Effect of Individual Psychological Intervention in Chinese Women With Gynecologic Malignancy: A Randomized Controlled Trial
Publication: Journal of Clinical Oncology
Abstract
Purpose
To evaluate the effectiveness of psychological intervention in the care of cancer patients and to determine whether routine use of individual psychological therapies is indicated.
Patients and Methods
Patients with newly diagnosed gynecologic malignancies from August 1999 to November 2000 were recruited and randomly assigned to either a control group receiving routine medical care or to an intervention group receiving individual psychotherapy. A set of fixed-choice, self-report questionnaires assessing the patients' psychological status, quality of life, and their perceptions related to the medical consultations was completed at recruitment and then every 3 months for 18 months. Data analysis was performed according to the intention-to-treat principle by fitting the data into a linear mixed-effects model. Multivariable analyses were performed to examine the effects of confounding factors.
Results
One hundred fifty-five patients participated in the trial. There were no statistically significant differences between the two groups at baseline. There was a trend toward better quality of life and functional status and also improvement of the symptoms over time for both groups. No differences were found between the groups in the scores measured by any of the instruments at baseline and at any time points after the cancer diagnosis. Psychological intervention had no significant effects on the psychosocial parameters.
Conclusion
Routine use of psychological therapies as given in our format has no significant effect on the patients' quality of life and psychological status.
Introduction
Cancer presents far more than a physical challenge. The psychological and medical problems encountered by cancer patients are numerous and unique. There is considerable evidence suggesting that cancer patients suffer from substantial and long-term psychological distress associated with different forms of cancer and its medical treatment. These psychological problems can, in fact, be more challenging to some cancer patients than the physical aspects of the disease, and contribute significantly to the overall suffering of the patients.1
In an attempt to improve emotional adjustment and prevent negative psychological effects, many intervention strategies have been used during the last 30 to 40 years.2-6 These interventions range from traditional approaches, such as psychotherapy, to the less orthodox music therapy and aromatherapy. Various components may be included, such as providing information or psychoeducation, peer discussion, coping strategies, biofeedback, relaxation, emotional expression, and cognitive-behavioral therapy. Patients may be treated in an individual format or in groups. The treatment may be offered formally or informally by health care professionals or by lay volunteers, including patients themselves. Moreover, they may be provided outside of hospitals by a wide variety of self-help groups or national and local cancer support organizations.
Recent surveys confirm the popularity of psychological therapies among cancer patients, with more than 50% of cancer patients in Australia, up to 29% of cancer patients of United States, and up to 10% of cancer patients in Europe and Canada reporting the use of at least one type of psychological therapy.7-12 Moreover, patients have high expectations for these therapies. In one study, up to 25% of participants expected the psychological therapy to cure their cancer, and 75% to 100% expected it to assist their traditional therapies.10
Despite the popularity of psychological therapy, there is an ongoing debate about whether and to what extent psychological care is effective in helping patients who suffer from cancer. Comparison of the results from previous studies on psychological intervention is hampered by differences in the time between diagnosis of cancer and inclusion in the study, in patient populations, in intervention strategies, and in outcome measures used. Long-term follow-up studies were rare. Despite the increased use of randomized, controlled trial designs over time, the methodologic quality of the intervention trials generally was suboptimal. The sample size of many studies generally was small. The randomization procedure and the characteristics of nonresponders were often not adequately described. The intention-to-treat principle may not have been followed.13,14 The possibility of publication bias is another concern, given that studies with negative results may not have been published.
A number of reviews have indicated support for psychological interventions in cancer patients.4-6,14-16 However, these reviews have been criticized for their lack of consideration of the methodologic rigor in the studies reviewed. Only two of these reviews excluded nonrandomized trials,6,15 and although some discussed the methodologic limitations of the included trials, methodologically inadequate studies were not excluded in the analyses, nor did they provide separate summaries for the more methodologically sound studies. Conversely, a meta-analysis that included more than 150 randomized, controlled trials published during 40 years was published recently.13 In the conclusion, the authors could make no strong recommendations and relatively few tentative recommendations about the effectiveness of psychological intervention strategies at improving cancer patients’ outcomes.13 Furthermore, recent articles in leading medical journals have also highlighted the need for objective and scientific evaluations of these psychological therapies, as opposed to blind dismissals.17-19
We believed that psychological intervention might be beneficial to patients with cancer. Because formal psychological interventions are not commonly provided in our local population, we performed this randomized study to evaluate the effectiveness of such interventions in the care of cancer patients. More importantly, because resources are limited, the results will be important to determine whether the routine use of psychological therapies is indicated.
Patients and Methods
A prospective randomized study was conducted with the approval of our hospital Institutional Review Board. This was a collaborative study between the Division of Gynaecological Oncology and the Clinical Health Psychology Division of the University of Hong Kong and the Queen Mary Hospital.
Patients with newly diagnosed gynecologic malignancies referred to our division from August 1999 to November 2000 were recruited to participate in the study. Newly diagnosed patients were chosen because a structured psychological intervention offered early on during the course of cancer diagnosis and treatment was considered to be less stigmatizing and more readily accepted by both patients and staff, and was expected to be more easily integrated into our comprehensive medical care program for cancer patients. The findings of our previous longitudinal study also suggested that all patients should be included in the program and the program should be offered early during the course of diagnosis and treatment.20
Inclusion criteria were age between 18 and 70 years, and the ability to understand and read Chinese. Patients with known confusion or who were judged too ill to participate were excluded. After written consent was obtained, the patient’s clinical and social data were obtained and the patient was randomly assigned either to a control group receiving routine medical care or to an intervention group receiving the same kind of routine medical care plus an individual psychological intervention. To ensure adequate blindness in the assessments, the group allocation was randomly assigned, the participant recruitment was performed by the medical staff, and the random assignment was performed separately by the research nurse using computer-generated number series contained within closed, opaque envelopes. The random assignment was stratified according to the site of disease.
Apart from the individual psychological interventions, both groups received the same treatment in accordance with standard clinical practices. The nature of the disease, the investigations, and the treatment protocol were outlined and explained. Booklets or pamphlets for routine distribution prepared before the design of this study were also provided to patients.
Intervention
For the intervention group, in addition to the usual medical care, the participants received individual psychological interventions, conducted by one of the two experienced clinical psychologists (A.S.M.F. or L.Y.F.W). Both psychologists had more than 10 years clinical experience in counseling and treating cancer patients. Before the start of the study, the clinical psychologists attended a series of discussion and information sessions with the team of gynecologic oncologists and nursing staff. Through these sessions, the clinical psychologists gained basic knowledge regarding the diseases, the principles of treatment, and the normal routines for the oncology division.
An initial intake assessment was routinely done at the first encounter. This included assessment of the developmental and personal history, magnitude of the patient’s psychosocial stresses, coping and social resources, worries and anxieties in relation to cancer, risks for developing psychological and emotional problems, and current mental health status, with particular emphasis on identifying pathologic signs of anxiety, depression, or adjustment difficulties. The content to be covered was formulated and refined after trial runs in 20 patients with known gynecologic cancers before the start of the study. This helped the clinical psychologists understand further the specific concerns and reactions related to the gynecologic cancer treatments.
Because each person and each situation is unique, the psychological care that followed was individually tailored, with the following therapeutic considerations: exert caution not to ask patients to reveal or deal with their feelings about cancer prematurely at the start of the consultation; expand patient’s perspectives on cancer treatment; work within values inherent in the Chinese culture; help patients see the integral link between thoughts, emotions, and physical well-being; promote an active and positive stance against cancer; and respect individual differences in preferences, needs, and choices. Although effort was made to recognize individual differences in needs and preferences, and to tailor interventions to each patient’s pace and knowledge, a number of core intervention components are included. The core components include: psychoeducation and supportive care, stress management, brief crisis counseling, relaxation, pain and distress management, and management of specific symptom spectrum (eg, anxiety, depression, and adjustment disorders) with the use of cognitive-behavioral therapy.21,22 The core therapeutic components are highlighted so that the interventions are comparable across psychologists and patients. Future replication is also possible with inclusion of the core components listed. Psychological interventions were provided throughout the treatment process and up to 18 months afterward, approximately once every 2 weeks during active treatment and once every 6 weeks during the follow-up period. The psychologists also held biweekly meetings to discuss patient progress, consult with each other about treatment strategies, and also ensure comparability of their treatment approaches.
During the course of the psychological intervention, if the patient expressed any doubts, thoughts, or emotions deemed to be important in affecting her participation in treatment, or if the patient was noted to harbor any misunderstanding or misperception regarding clinical management, the problem was referred back to the treating doctor of the oncology team for additional support and clarification.
Measures
Both groups of patients were asked to complete a set of questionnaires at recruitment (about 1 week before the psychosocial intervention) and then every 3 months for 18 months during their visits in the outpatient clinics after medical consultations. The study coordinator was available to answer any questions and to collect the questionnaires before the patients left the hospital. The entire list of questionnaires took approximately 30 minutes to complete. A time window of 2 weeks was maintained for acceptance of questionnaires.
The fixed-choice, self-report questionnaires assessed the patients’ psychological status, quality of life (QOL), and their perceptions related to the medical consultations. We did not assess sexual function because our female population tends to weigh sex as a minor concern23 and we did not want to be disadvantaged by a high attrition rate associated with other studies on sexual function.24 Moreover, assessing sexual function was not our primary objective.
QOL.
The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a standardized self-administered questionnaire measuring aspects of QOL relevant to cancer patients. It was developed for use in clinical trials to evaluate the effect of cancer and its treatment on multidimensional QOL. It has also been validated and cross-culturally tested by the EORTC Study Group on Quality of Life.25-27 The Chinese translation of the third-generation questionnaire, EORTC QLQ-C30, was used in this study. It consists of 30 items (each scored either as 4 or 7 points), most of which measure the patients’ symptoms in the preceding week. The 30 items form a global health status, five functional scales, three symptom scales, and six single items. In the functional scales, a high score indicates a good function. In the symptom scales and items, a high score indicates a severe symptom.
Beck Depression Inventory–second edition and Beck Anxiety Inventory.
The Chinese version of the Beck Depression Inventory–second edition (BDI-II) and Beck Anxiety Inventory (BAI) were chosen to measure depression and anxiety, respectively. They have been validated previously, and show good reliability and validity.28-30 The BDI-II is one of the most widely used instruments for both assessing the intensity of depression and detecting depression in normal populations, whereas BAI measures the symptoms of anxiety with minimal overlap with those of depression. The total score of each scale reflects the overall severity, with higher scores indicating more severe depression or anxiety.
The Impact of Events Scale.
The Impact of Events Scale (IES) was widely adopted in research studying the psychological impact of trauma. The IES was designed to tap into two of the most commonly reported psychological response patterns associated with trauma: intrusive and avoidance symptoms. The IES has also been used in research studying the psychological impact of specific traumatic life events and as an outcome measure in treatment studies; a higher score indicates a more significant degree of distress. The reliability and validity of the Chinese version have been verified and has high internal consistency.31,32
Generalized Self-Efficacy Scale.
Self-efficacy is posited in social cognitive theory as fundamental to behavior change, and building self-efficacy is a reasonable starting point for any intervention. The Generalized Self-Efficacy Scale consists of 10 items and each is rated on a 4-point scale. The scale was designed to measure perceived coping ability across a wide range of demanding situations and provides a measure of general adaptational outcomes. The Chinese version has been validated and found to have good internal consistency (α = .92).33 Higher scores indicate higher degree of self-efficacy.
Self-Esteem Scale.
The Rosenberg Self-Esteem Scale was developed to measure global attitudes toward oneself through five positively worded and five negatively worded items. It has become the most widely used measure of self-esteem and it has also been used in Chinese populations. The Chinese version has demonstrated acceptable internal consistency among the Hong Kong Chinese population.34 The reliability and validity of the Chinese version have also been verified.35
Medical Interview Satisfaction Scale.
The Medical Interview Satisfaction Scale is a 26-item, 5-point, Likert-scored instrument composed of cognitive, affective, and behavioral subscales. It has been found to have good internal consistency (α = .9) and the scores reflect patients’ need fulfillment, with a greater number of expectations met during consultation associated with higher consultation satisfaction,36,37 indicated by higher scores.
Statistical Analysis
The sample size was computed based on the main outcome, global health status (QL2) of the EORTC-QLQ. From our previous study,20 the standard deviation for the change of QL2 was approximately 22 points. A difference of 10 points or more was considered to be clinically significant.38,39 Taking an effect size of 10 between the two groups, 77 participants per group were needed to achieve a power of 80% and a maximum of 5% false-positive error rate by a two independent samples t test. Assuming a small attrition rate, 80 participants per group were planned.
The scoring of the questionnaires was performed according to the scoring manuals. All participants were included as randomly assigned in the statistical analysis. An intention-to-treat approach was used for all analyses. There was no predetermined number of follow-up or treatment sessions which subjects were required to complete to test the effectiveness of the psychological intervention.
Compliance at each assessment was calculated as the percentage of returned questionnaires in relation to the number expected. The number of expected questionnaires was the difference between the number of patients included and those who died during the study. The number of returned questionnaires with missing items leading to missing scores for the scales at each assessment was counted and compared between the two groups.
For each scale of all questionnaires, a linear mixed-effects model was used to examine the effect of the psychological intervention. The data on participants with baseline measurements and at least one postbaseline measurement were included in the analyses. Specifically, the intercept was treated as a random effect to account for the dependence among repeated measurements of each participant over time. The time after baseline (in months), group, and the baseline measurement of the scale were treated as fixed effects. With all scale measurements after baseline as the dependent variable, the restricted maximum likelihood method was used to estimate all effects. Normality of the residuals and random effects was examined using the normal probability plot.
Multivariable analyses were performed to examine the effects of confounding factors, including patients’ age at diagnosis, site and stage of diseases, treatment modality, religion, and education level, in addition to time after baseline and group. The mixed-effects modeling approach was used with all confounding factors treated as fixed effects and the intercept treated as a random effect. A forward stepwise variable selection procedure was adopted to determine which confounding factors had independent effects on a scale of a questionnaire.
P values less than .05 were considered statistically significant. The statistical analysis was carried out using the Statistical Analysis System (SAS) version 8.2 (SAS Institute Inc, Cary, NC).
Results
Of the total of 173 women with newly diagnosed gynecologic malignancies seen during the period of recruitment, 160 patients fulfilled the inclusion criteria. Five patients refused participation because they found completing the questionnaires cumbersome or they preferred to avoid thinking about their diseases. The remaining 155 patients (96.9%) agreed to participate and were entered onto the trial, with 80 patients randomly assigned to the study group and 75 patients randomly assigned to the control group.
Table 1 summarizes the patient characteristics. There were no statistically significant differences in demographic and illness characteristics between the two groups at baseline. Three patients in the control group were later referred to the clinical psychologists because of their clinical needs. Two patients in the study group did not attend the psychological intervention because they considered it inconvenient and they did not feel the need.
The compliance rate at the different time points ranged from 66% to 95%; the compliance rate remained at approximately 70% from 12 to 18 months (Table 2). The majority of participants (84%) who did not want to continue participation withdrew before 9 months. The reasons for nonparticipation were mainly unwillingness to complete the questionnaires because they considered the questionnaires too long, or a preference to avoid thinking about their illness. Two patients in each group withdrew after experiencing recurrent disease. There were no systematic differences in the distribution of compliance and number of questionnaires with missing scores between the two groups. The precision of the estimates might be slightly lower mainly due to missing values at follow-up. However, the SEs of the overall treatment effects were generally small. For the main outcome QL2 of EORTC-QLQ, the 95% CI for the effect of psychological intervention was −7.4 to 4.5, which was within the targeted 10-point difference of meaningful effect. Therefore, the main conclusions of this study do not seem to be influenced significantly by the presence of missing data.
The mean scores for all patients at the seven time points are shown in a panel of graphs in Figures 1 to 3. No differences were found between the groups in the scores measured by any of the instruments at baseline and at any time points after the diagnosis of gynecologic malignancy. There was a trend toward better QOL and functional status, and also improvement of the symptom scales over time for both groups. There were clinically significant improvements (> 10 points difference) over time in terms of the overall QOL and most of the functional scales and symptom scales of the EORTC QLQ-C30, starting from 6 months onward. For the scales measuring psychological status in Figure 3, the scores of the scales were stable over time. There was only a mild degree of anxiety and depression among our patients. The degree of satisfaction toward the medical and health care team was consistently high throughout the treatment and follow-up periods.
Table 3 shows the results of the linear mixed model. Patients in the intervention group were coded as 1, whereas patients in the control group were coded as 0. For example, an effect of −1.46 for QL2 means patients who underwent the psychological intervention had QL2 lower than patients in the control group by an average of 1.46. There was no statistically significant effect of psychological intervention on most of the parameters tested, except for the physical and role functioning scales. In these two scales, negative effects were seen in patients with psychological interventions. However, on multivariable analysis (Table 4), the effects of group allocation were insignificant in all the parameters tested. Moreover, patients with different diagnoses did not seem to respond differently to the intervention in all parameters.
From the results of multivariable analysis, time since first diagnosis was the most significant predictor of outcome and adjustment status. Other factors important in determining the final outcomes were patient’s age, the disease stage at diagnosis, and education level. Older patients had poorer physical, role, and cognitive functioning, and more fatigue and financial problems than younger patients. For disease stage at diagnosis, more extensive diseases as measured by the International Federation of Gynecology and Obstetrics stage were associated with poorer physical, role, emotional, and social functioning, and more fatigue, dyspnea, and appetite loss. Patients with lower educational levels reported having less pain and anxiety but had lower scores on self-esteem.
Discussion
This was a randomized study investigating the effects of psychological intervention in patients with gynecologic malignancies. Our study fulfilled most of the methodologic quality indicators for an optimally designed study. Steps were taken to ensure adequate concealment of treatment allocation and to ensure that patients were randomly selected. There were well-established treatment protocols for various gynecologic malignancies. Both groups in this study were treated according to standard clinical procedures, with similar distribution in terms of disease sites and stage, and the types of cancer treatment. Medical care for participants in both groups was equivalent apart from the psychological intervention provided by the psychologists.
Self-report instruments and scales were used because the patient is the most relevant person to evaluate her own QOL and psychological status. The questionnaires used in this study have been thoroughly evaluated, with confirmed validity and reliability. The measures contain general as well as specific questions to give a fair picture of condition of our patients with cancer. They are also proven to be sensitive to changes over time and suitable for use in different subgroups of patients. Therefore, we consider the instruments chosen as being appropriate, despite the lack of significant results found. Moreover, we adhered to the principle of intention-to-treat, and individual patients were used as their own control on data analysis.
Despite the fact that the patients in the study group received regular psychological intervention provided by the clinical psychologists, the program did not improve their QOL or psychological status when compared with the control group. The overall result is consistent with the results of a large number of studies40-47 and a recently published meta-analysis13 that failed to demonstrate a conclusive effect of psychosocial intervention on psychological well-being.
Several explanations are possible. First, the effect of the present program may be weak, and our sample size may not be sufficient to show the difference. In the present study, both groups of patients had low scores in the scales measuring anxiety and depression, and high scores in the medical interview satisfaction scale, at baseline. The floor effect and ceiling effect may hinder the detection of any significant improvements in these areas. It should be pointed out that in comparing our participants with those typically reported in other studies, our participants clearly showed much less psychological morbidity in terms of anxiety, depression, or adjustment disorders at baseline. Given the relative robust adjustment of our participants, it is conceivable that their need for and hence their responses to formal psychological intervention might be less obvious compared with patients with more significant psychopathologies.
The degree of satisfaction with our medical team as evaluated by the patients was consistently high throughout the study period. This indicated that our medical staff in general has good communication skills and a caring attitude toward our patients. This may constitute a certain degree of psychosocial care and support. With the same team of medical staff managing all of the patients and with a similar degree of medical satisfaction for both groups of patients, the effects of this on the psychological adjustment, if any, should be the same for both groups. Moreover, whether this kind of care and support is sufficient to bring about an optimal QOL and adjustment to cancer is unclear. We are not aware of any studies comparing the psychosocial and supportive care provided by the medical staff versus the formal psychological therapy provided by clinical psychologists.
Second, the effect of the interventions may have been diluted by the inclusion of unselected patient groups rather than patients selected for their need for psychological intervention. Consequently, a significant proportion of the participants receiving the intervention might not need it or benefit from it. This would substantially reduce the effects of the intervention. A more stringent test of the impact of psychological intervention may be to select patients with documented psychological and adjustment morbidity at baseline and to randomly assign such patients into a treatment and control group. This procedure would maximize the impact of psychological interventions on the at-risk patient population without suffering from the effect of dilution of clinical impact when patients without such need are excluded. However, if the control patients were assessed and noted to suffer from significant psychological morbidities, yet available psychological intervention was not offered as dictated by the study design, the inherent ethical problems might have to be more carefully considered. We also noted that no statistically significant effects of psychological interventions were identified from the few trials conducted on patients at risk of psychological distress.48-51
Third, a number of questionnaires were used in this study. The EORTC QLQ-C30 has a major focus on the physical aspects of QOL and it may not be sensitive enough to detect changes that are influenced by our psychological intervention. Therefore, we also used other psychological instruments to give a comprehensive assessment of participants’ psychological status over time. However, these instruments were not designed specifically for use in cancer patients, and this may undermine the results of the present study. Nevertheless, the constancy of our results as measured by these instruments provides evidence for the robustness of our conclusions.
Fourth, the many studies that gave positive results for psychological intervention may be a result of publication bias, given that some studies with negative results may not have been published. Some of the positive effects of intervention reported in previous studies may have been chance findings, given that many of the studies included multiple scales and thereby made multiple comparisons, with a strong probability of chance findings. In one study, a significant effect on one scale of depression could not be demonstrated on another scale.52 Moreover, the mechanisms by which psychological interventions can modify the course of the disease or even the disease itself still remain unknown.
Our results do suggest that time is an important factor for patients to recover from the physical and psychological trauma of cancer. There was a trend toward better QOL and functional status and also improvement of the symptom scales over time. Elapsed time from diagnosis was the most significant factor affecting the patients’ outcomes in terms of QOL and psychological well-being. This is consistent with our findings in the previous longitudinal observational studies.20,53 Therefore, irrespective of whether psychological intervention was performed, the patients’ QOL and functional status improved over time and became clinically significant from 6 months after diagnosis. This could be due to the effectiveness of cancer treatment and recovery from the disease, given that most of the treatment should have been completed by 6 months. However, it seems that time is still the most important factor for healing and recovery from the physical and psychological trauma of the cancer.
There are two potential limitations to this study. First, as discussed, the study was performed on unselected patients with newly diagnosed gynecologic malignancy. Together with the floor effect observed, the sample size certainly is not sufficient to allow for subgroup analysis for those in need of psychological care based on their baseline measurements. Thus, our results probably do not apply well to cancer patients at risk for psychological morbidities. Second, our participants were Chinese women in Hong Kong, and our results may not be generalizable to other racial or ethnic groups. Additional work may clarify the generality of the study findings to other populations.
In summary, routine use of formal psychological therapies as given in our format does not have a significant effect on the patients’ QOL and psychological status. This study highlighted the importance of thorough evaluation of any intervention by randomized controlled trial before routine clinical implementation. Additional studies are needed to evaluate the effectiveness of other strategies of psychosocial intervention, such as group therapy, cognitive behavioral therapy, interventions involving patients’ significant others, and the interaction between self-efficacy and benefit from the interventional therapies.
Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
| Characteristic | Intervention Group (n = 80) | Control Group (n = 75) | P |
|---|---|---|---|
| Age, years | |||
| Mean | 45.3 | 44.18 | .30 |
| SD | 9.5 | 11.6 | |
| Median | 45.0 | 42.5 | |
| Duration of marriage, years | .94 | ||
| Mean | 17.9 | 18.2 | |
| SD | 9.4 | 10.7 | |
| No. of children | .55 | ||
| Mean | 1.8 | 1.7 | |
| SD | 1.5 | 1.7 | |
| Religion, No. | .60 | ||
| Nil | 48 | 37 | |
| Buddhist | 14 | 14 | |
| Catholic | 4 | 8 | |
| Christian | 11 | 13 | |
| Other | 3 | 3 | |
| Marital status, No. | .22 | ||
| Single | 15 | 17 | |
| Married | 52 | 47 | |
| Divorced | 3 | 7 | |
| Widowed | 10 | 4 | |
| Occupation, No. | .76 | ||
| Unemployed | 7 | 7 | |
| Clerical | 31 | 33 | |
| Nonclerical | 42 | 35 | |
| Education level, No. | 1.00 | ||
| Nil | 4 | 4 | |
| Primary | 18 | 16 | |
| Secondary | 47 | 44 | |
| Tertiary | 11 | 11 | |
| Site of disease, No. | .99 | ||
| Ovary | 39 | 36 | |
| Corpus | 11 | 10 | |
| Cervix | 25 | 25 | |
| Others | 5 | 4 | |
| FIGO stage, No. | .27 | ||
| I | 41 | 47 | |
| II | 9 | 9 | |
| III | 26 | 14 | |
| IV | 4 | 5 | |
| Primary treatment to be received, No. | .49 | ||
| Surgery | 31 | 29 | |
| Radiotherapy or chemoradiation | 9 | 12 | |
| Chemotherapy | 6 | 2 | |
| Surgery and chemotherapy | 34 | 32 |
Abbreviations: SD, standard deviation; FIGO, International Federation of Gynecology and Obstetrics staging system.
| Parameter | Intervention Group (months) | Control Group (months) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 3 | 6 | 9 | 12 | 15 | 18 | 0 | 3 | 6 | 9 | 12 | 15 | 18 | |||||||||||||
| No. of deaths, cumulative | 0 | 2 | 2 | 3 | 6 | 8 | 11 | 0 | 1 | 3 | 4 | 7 | 9 | 10 | ||||||||||||
| Expected No. of questionnaires | 80 | 78 | 78 | 77 | 74 | 72 | 69 | 75 | 74 | 71 | 67 | 64 | 62 | 61 | ||||||||||||
| No. of questionnaires not given to patient | 1 | 0 | 1 | 2 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 2 | ||||||||||||
| No. of patients who did not want to participate, cumulative | 2 | 13 | 13 | 16 | 16 | 17 | 18 | 2 | 11 | 11 | 11 | 12 | 13 | 14 | ||||||||||||
| No. of questionnaires not returned | 2 | 2 | 2 | 2 | 3 | 1 | 2 | 2 | 2 | 3 | 3 | 4 | 2 | 5 | ||||||||||||
| No. of questionnaires returned, No. | 75 | 63 | 62 | 57 | 55 | 53 | 48 | 71 | 61 | 56 | 53 | 47 | 46 | 40 | ||||||||||||
| Compliance, % | 94 | 81 | 79 | 74 | 74 | 74 | 70 | 95 | 82 | 79 | 79 | 73 | 74 | 66 | ||||||||||||
| No. of questionnaires with missing scores | ||||||||||||||||||||||||||
| EORTC QLQ-C30 | ||||||||||||||||||||||||||
| QL2 | 0 | 2 | 2 | 2 | 3 | 2 | 1 | 0 | 2 | 3 | 2 | 2 | 0 | 1 | ||||||||||||
| PF/RF2/EF/CF/SF | 0 | 2 | 3 | 2 | 2 | 1 | 2 | 0 | 3 | 3 | 2 | 2 | 1 | 2 | ||||||||||||
| FA/NV/PA/DY/AP/CO/DI/FI | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 0 | 2 | 3 | 1 | 2 | 1 | 1 | ||||||||||||
| BDI-II | 4 | 1 | 3 | 2 | 2 | 2 | 2 | 3 | 2 | 3 | 2 | 3 | 2 | 2 | ||||||||||||
| BAI | 0 | 2 | 2 | 3 | 3 | 2 | 1 | 0 | 3 | 3 | 3 | 2 | 2 | 2 | ||||||||||||
| IES | 3 | 3 | 2 | 4 | 2 | 2 | 2 | 7 | 2 | 2 | 2 | 3 | 2 | 1 | ||||||||||||
| GSES | 9 | 3 | 3 | 3 | 2 | 2 | 2 | 9 | 4 | 4 | 3 | 2 | 3 | 2 | ||||||||||||
| SES | 2 | 4 | 4 | 3 | 3 | 2 | 1 | 5 | 3 | 3 | 2 | 2 | 2 | 1 | ||||||||||||
| MISS | 6 | 5 | 6 | 4 | 2 | 3 | 1 | 4 | 2 | 3 | 1 | 2 | 3 | 2 | ||||||||||||
Abbreviations: EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; QL2, global health status (revised); PF, physical functioning; RF2, role functioning (revised); EF, emotional functioning; CF, cognitive functioning; SF, social functioning; FA, fatigue; NV, nausea and vomiting; PA, pain; DY, dyspnea; AP, appetite loss; CO, constipation; DI, diarrhea; FI, financial difficulties; BDI-II, Beck Depression Inventory–second edition; BAI, Beck Anxiety Inventory; IES, Impact of Events Scale; GSES, Generalized Self-Efficacy Scale; SES, Self-Esteem Scale; MISS, Medical Interview Satisfaction Scale.
| Scale | Estimated Effect | SE | P |
|---|---|---|---|
| EORTC-QLQ | |||
| QL2 | −1.46 | 3.03 | .63 |
| PF | −5.54 | 2.73 | .04 |
| RF2 | −8.35 | 4.06 | .04 |
| EF | −3.35 | 3.06 | .27 |
| CF | −2.69 | 3.03 | .38 |
| SF | −5.49 | 3.81 | .15 |
| FA | 5.51 | 3.50 | .17 |
| NV | 4.50 | 2.42 | .06 |
| PA | 5.01 | 3.58 | .16 |
| DY | 3.57 | 3.79 | .35 |
| AP | 3.24 | 3.51 | .36 |
| CO | 4.30 | 3.41 | .21 |
| DI | −0.63 | 3.14 | .84 |
| FI | 6.52 | 4.35 | .14 |
| Other parameters | |||
| BDI-II | −1.23 | 1.16 | .29 |
| BAI | −0.56 | 1.10 | .61 |
| IES-intrusive | −0.27 | 1.21 | .82 |
| IES-avoidance | −0.30 | 1.20 | .81 |
| GSES | −0.64 | 1.08 | .56 |
| SES | −0.44 | 0.55 | .42 |
| MISS | −0.02 | 0.08 | .78 |
Abbreviations: EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; QL2, global health status (revised); PF, physical functioning; RF2, role functioning (revised); EF, emotional functioning; CF, cognitive functioning; SF, social functioning; FA, fatigue; NV, nausea and vomiting; PA, pain; DY, dyspnea; AP, appetite loss; CO, constipation; DI, diarrhea; FI, financial difficulties; BDI-II, Beck Depression Inventory–second edition; BAI, Beck Anxiety Inventory; IES, Impact of Events Scale; GSES, Generalized Self-Efficacy Scale; SES, Self-Esteem Scale; MISS, Medical Interview Satisfaction Scale.
| Scale | Study Group | Age | Religion | Type of Treatment | FIGO Stage | Site of Disease | Time From Diagnosis | Education Level |
|---|---|---|---|---|---|---|---|---|
| EORTC-QLQ | ||||||||
| QL2 | NS | NS | NS | NS | NS | NS | < .01 | NS |
| PF | NS | < .01 | NS | < .01 | .02 | NS | < .01 | NS |
| RF2 | NS | .02 | NS | NS | < .01 | NS | .01 | NS |
| EF | NS | NS | NS | NS | .03 | NS | .01 | NS |
| CF | NS | < .01 | NS | NS | NS | NS | NS | NS |
| SF | NS | NS | NS | .05 | .03 | NS | < .01 | NS |
| FA | NS | .03 | NS | NS | .03 | NS | < .01 | NS |
| NV | NS | NS | NS | NS | .03 | .01 | < .01 | NS |
| PA | NS | NS | NS | NS | NS | NS | < .01 | 0.04 |
| DY | NS | NS | NS | NS | < .01 | NS | NS | NS |
| AP | NS | NS | NS | NS | .01 | NS | < .01 | NS |
| CO | NS | NS | NS | NS | NS | NS | .01 | NS |
| DI | NS | NS | NS | < .01 | NS | NS | NS | NS |
| FI | NS | .01 | NS | NS | NS | NS | < .01 | NS |
| Other parameters | ||||||||
| BDI-II | NS | NS | NS | NS | NS | NS | NS | NS |
| BAI | NS | NS | NS | NS | NS | NS | NS | 0.03 |
| IES-intrusive | NS | NS | NS | NS | NS | NS | .04 | NS |
| IES-avoidance | NS | NS | NS | NS | NS | NS | .04 | NS |
| GSES | NS | NS | .02 | NS | NS | NS | NS | NS |
| SES | NS | NS | NS | NS | NS | NS | < .01 | 0.03 |
| MISS | NS | NS | NS | NS | NS | NS | NS | NS |
Abbreviations: FIGO, International Federation of Gynecology and Obstetrics staging system; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; NS, nonsignificant (P > .05); QL2, global health status (revised); PF, physical functioning; RF2, role functioning (revised); EF, emotional functioning; CF, cognitive functioning; SF, social functioning; FA, fatigue; NV, nausea and vomiting; PA, pain; DY, dyspnea; AP, appetite loss; CO, constipation; DI, diarrhea; FI, financial difficulties; BDI-II, Beck Depression Inventory–second edition; BAI, Beck Anxiety Inventory; IES, Impact of Events Scale; GSES, Generalized Self-Efficacy Scale; SES, Self-Esteem Scale; MISS, Medical Interview Satisfaction Scale.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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© 2005 by American Society of Clinical Oncology.
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Published in print: August 01, 2005
Published online: September 21, 2016
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Effect of Individual Psychological Intervention in Chinese Women With Gynecologic Malignancy: A Randomized Controlled Trial. JCO 23, 4913-4924(2005).
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