Background
Methods
Search and identification of studies
Data collection
Results
Study selection
Characteristics of included studies
Study and location | Patient population | Intervention | Control | Length of follow up | Study outcomes | Results | Critical appraisal score |
---|---|---|---|---|---|---|---|
Beaver et al., 2009 Manchester, UK [11] | 374 breast cancer patients | Telephone follow up by specialist nurses | Usual hospital care | 24 months (mean) | Psychological morbidity | Equivalence trial - : no difference between the two groups | Study Quality – 8/10 |
Participant’s needs for information | External validity – 2/3 | ||||||
Participant’s satisfaction | Internal Validity (bias) – 6/7 | ||||||
Clinical Investigations ordered | Internal Validity (selection bias) – 6/6 | ||||||
Time to detection of recurrent disease | Power – 1/1 (Total – 23/27) | ||||||
Beaver et al., 2009 (Economic evaluation) Manchester, UK [25] | 374 breast cancer patients | Cost minimization analysis of RCT above | - | 24 months (mean) | Primary: NHS resource use | Telephone follow-up more costly (mean difference £55 but telephone patients had lower personal costs (mean difference £47) | No score as cost analysis |
Secondary: patient, carer and productivity courses | |||||||
Davison and Degner, 2002 Vancouver, Canada [15] | 749 breast cancer patients | Computer programme providing information and assisting decision making | Standard care only- asked about decision making before clinic appointment | One clinic visit | Involvement in decision making | Women in the intervention group reporting playing a more passive role. | Study Quality – 6/10 |
Patient satisfaction | Patient satisfaction was high in both groups | External validity – 2/3 | |||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 4/6 | |||||||
Power – 0/1 (Total – 17/27) | |||||||
Harrison et al., 2011 Sydney, Australia [21] | 75 patients with colorectal cancer | 5 telephone calls from a specialist colorectal nurse in 6 months after discharge | Standard care | 6 months | Unmet supportive care needs | No difference between the groups for unmet needs and health service utilization | Study Quality – 8/10 |
Health service utilization | Quality of life scores higher in the intervention group at 6 months | External validity – 2/3 | |||||
Quality of life | Internal Validity (bias) – 5/7 | ||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 0/1 (Total – 21/27) | |||||||
Hegel et al., 2010 New Hampshire, USA [16] | 31 Breast cancer patients | 6 weekly session of telephone delivered problem solving occupational therapy | Usual care | 12 weeks | Primary outcome: feasibility of conducting the trial | Overall positive outcomes | Study Quality – 8/10 |
Secondary outcomes: functional, quality of life and emotional status | External validity – 3/3 | ||||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 0/1 (Total – 20/20) | |||||||
Kearney et al., 2008 Stirling, Scotland [12] | 112 cancer patients | Mobile phone-based remote monitoring during chemotherapy | Standard care | 16 weeks | Chemotherapy related morbidity – 6 common symptoms, nausea, vomiting, fatigue, mucositis, hand-foot syndrome and diarrhoea | Higher reports of fatigue in the control group and lower reports of hand-foot syndrome in the control group | Study Quality – 8/10 |
External validity – 1/3 | |||||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 0/1 (Total – 20/27) | |||||||
Kimman et al., 2011 Maastricht, Netherlands [17] | 299 women with breast cancer | Nurse led telephone follow up or | Hospital follow up or hospital follow up plus EGP | 18 months | Health related quality of life (HRQoL) | No difference between the two groups | Study Quality – 8/10 |
Nurse led telephone follow up plus educational group programme (EGP) | Secondary measures included role and emotional functioning and feelings of control and anxiety | External validity – 2/3 | |||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 1/1 (Total – 22/27) | |||||||
Kimman et al., 2011 Maastricht, Netherlands [27] | 299 women with breast cancer | Nurse led telephone follow up or Nurse led telephone follow up plus educational group programme (EGP) | Hospital follow up or hospital follow up plus EGP | 18 months | Quality adjusted life gain (QALYs) | Hospital follow-up plus EGP resulted in the highest QALYs but has the highest costs. Next best in terms of costs and QALYs was nurse led telephone follow up plus EGP | No score as cost analysis |
Incremental cost-effectiveness ratios (ICERs) | |||||||
Kimman et al., 2010 Maastricht, Netherlands [13] | 299 women with breast cancer | Nurse led telephone follow up or | Hospital follow up or hospital follow up plus EGP | 12 months | Patient satisfaction | Increased patient satisfaction with access to care in telephone follow-up group. No significant influence on general patient satisfaction, technical competence or inter-personal aspects | Study Quality – 9/10 |
Nurse led telephone follow up plus educational group programme (EGP) | External validity – 2/3 | ||||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 5/6 | |||||||
Power – 1/1 (Total – 22/27) | |||||||
Kroenke et al., 2010 Indiana, USA [26] | 405 cancer patients | Centralized telecare management by a nurse-physican specialist team coupled with home-based symptom monitoring by interactive voice recording or internet | Usual care | 12 months | Depression Pain | Improvements in pain and depression for the intervention group | Study Quality – 8/10 |
External validity – 2/3 | |||||||
Internal Validity (bias) 6/7- | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 1/1 (Total – 23/27) | |||||||
Marcus et al., 2009 Colorado, USA [18] | 304 breast cancer patients | 16 session telephone counselling post treatment | Resource directory for breast cancer was given to each patient | 18 months | Distress | No difference for distress and depression | Study Quality – 8/10 |
Depression | Need for clinical referral – depression and distress reduced by 50% in the intervention group for dichotomized end points | External validity – 2/3 | |||||
Sexual dysfunction | Effects found for personal growth and sexual dysfunction in the intervention group | Internal Validity (bias) – 5/7 | |||||
Personal growth | Internal Validity – 5/6 (selection bias) | ||||||
Power – 0/1 (Total – 20/27) | |||||||
Matthew et al., 2007 Toronto, Canada [20] | 152 prostate cancer patients | PDA survey followed by paper | Paper followed by PDA survey | 30 mins | Survey was monitoring health-related quality of life but outcomes looked at assessment of data quality and feasibility | Internal consistency similar | Study Quality – 8/10 |
PDA followed by PDA survey. (3 groups) | Test re-test reliability confirmed | External validity – 3/3 | |||||
Data from two modalities strongly correlated. | Internal Validity (bias) – 5/7 | ||||||
Fewer missed items for the PDA | Internal Validity (selection bias) – 5/6 | ||||||
More preferred using the PDA or had no preference. PDA found easy to use | Power – 0/1 (Total – 21/27) | ||||||
Age did not correlate with difficulty using PDA | |||||||
Sandgren et al., 2003 North Dakota, USA [19] | 222 women with breast cancer | 6×30 min telephone therapy sessions that involved either cancer education or emotional expressions | Standard care | 5 months | Perceived control | Cancer education group reported greater perceived control compared to standard care | Study Quality – 7/10 |
Mood | |||||||
Quality of life | No difference for mood or quality of life | External validity – 2/3 | |||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 1/1 (Total – 21/27) | |||||||
Sikorski et al., 2009 Michigan, USA [22] | 486 cancer patients | Automated voice response symptom reporting | Nurse assisted symptom management via the telephone | 6 telephone contacts over 8 weeks | Severity of cancer symptom at intake interview and at first intervention contact | Patient in the AVR group reported more severe symptoms. There was a variation with age with older patients reporting more severity of symptoms to the nurse | Study Quality – 9/10 |
External validity - 2/3 | |||||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 0/1 (Total – 22/27) | |||||||
Sikorskii et al., 2007 Michigan, USA [23] | 435 cancer patients | Automated telephone symptom management | Nurse-assisted symptom management | 10 weeks | Severity of cancer symptoms, demographic data and co-morbidities | Reduction in symptom severity in both groups. Lung cancer patients with greater symptom severity withdrew from the ATSM group | Study Quality – 8/10 |
External validity – 2/3 | |||||||
Internal Validity (bias) – 5/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 1/1 (Total – 22/27) | |||||||
Yun et al. 2012 Seoul, Korea [24] | 273 cancer patients | Internet based, individually tailored cancer related fatigue education program | Usual care | 12 weeks | Level of fatigue | Education group reported a reduction in fatigue, decrease in HADS anxiety score, increase in global QoL score and emotional, cognitive and social functioning of EORTIC QLQ-C30 | Study Quality – 8/10 |
Quality of Life, Anxiety and depression | External validity – 1/3 | ||||||
Internal Validity (bias) – 4/7 | |||||||
Internal Validity (selection bias) – 6/6 | |||||||
Power – 1/1 (Total – 20/27) |
Study | Intervention | Primary and secondary outcomes | Measures used | Results including statistical values |
---|---|---|---|---|
Telephone follow up by specialist nurses | Psychological Morbidity | State-trait anxietntdy inventory | No difference for psychological morbidity | |
Participant’s need for information | General Health Questionnaire | Patients in telephone group more satisfied (intention to treat p < 0.001) | ||
Participants’ satisfaction | No difference for information needs | |||
Clinical investigations ordered | No difference for clinical investigations | |||
Time to detection of recurrent disease | Recurrences :- no differences between the two groups p = 0.295% CI (−3.33-2.07) – equivalence demonstrated. 28) | |||
Davison et al. (2002) [15] | Computer programme providing information and assisting decision making | “Extent to which women achieved their preferred decisional roles” | Control Preferences Scale (CPS) | Intervention group was more passive in decision making than planned. (p < 0.0001) |
Patient satisfaction | Patient Satisfaction Questionnaire (PSQ) | More women over 50 opted to play a more passive role. (p= > 0.002) | ||
No difference found for the two groups for patient satisfaction. Both groups reported high levels | ||||
Harrison et al. (2011) [21] | 5 telephone calls from a specialist colorectal nurse in 6 months after discharge | Unmet supportive care needs | SCNS-SF34 and FACT-C used for unmet supportive care needs and quality of life. CaSUN was used to measure these two outcomes at 6 months | No difference was found for unmet supportive care needs at 6 months |
Secondary outcomes: | Patient asked to remember health service use in a telephone interview | “Observed effect size for supportive care needs was 0.25“ | ||
Health service utilization | Study was aiming for effect size of 0.75. | |||
Quality of life | Quality of life had improved by “twice as much” in the intervention group at six months. (size of difference = 5.7) | |||
At 6 months in the intervention group; fewer “presentations to emergency departments (p = 0.23) and readmissions to hospital (p = 0.37)” compared with the control group. Intervention group patients had more contact with “hospital-based, specialist based and community services”. Differences for health service utilization were not statistically significant | ||||
Hegel et al. (2010) [16] | 6 weekly session of telephone delivered problem solving occupational therapy | Feasibility of conducting a RCT including patient satisfaction | Study recruitment and retention data was gathered | “67% recruitment rate (31/46)” |
Secondary outcomes:
| At 12 weeks participants completed a satisfaction survey | “81% retention rate” | ||
Functional quality of life
| “92% of those receiving the intervention were “highly satisfied” | |||
Emotional status
| 92% reported it to be “helpful/very helpful” | |||
97% if planned sessions of the intervention were completed | ||||
Effect sizes were calculated for secondary outcomes but “study was not powered to detect treatment effects”. Main outcome was feasibility for study to be repeated as larger scale RCT. No CIs quoted | ||||
Kearney et al. (2008) [12] | Mobile phone-based remote monitoring during chemotherapy | “Chemotherapy-related morbidity” of six symptoms | Electronic symptom questionnaire completed by patients in control and intervention group before the start of chemotherapy and prior to cycles 2, 3, 4 and 5 | In the control group more report of fatigue (CI = 1.04-5.05, P = 0.040) and lower reporting of hand-foot syndrome (CI 0.17-0.92 P = 0.031) Severity and distress of symptoms were no different between the two groups except for hand-foot syndrome in the intervention group. (Severity CI −0.52 to −0.02 P = 0.033, Distress CI −0.33 to −0.02, P = 0.028). Other differences were not statistically significant |
These were nausea, vomiting, fatigue, mucositis, hand-foot syndrome and diarrhoea” | ||||
Nurse led telephone follow up or | Health-related quality of life (HRQoL) | HRQoL: EORTC QLQ-C30 | No difference between the two groups for HRQoL. (P value = 0.42 | |
Nurse led telephone follow up plus educational group programme (EGP) | Secondary outcomes: | Role and emotional functioning: EORTC QLQ-C30 subscales | Confidence interval of 95% for the “estimated difference between mean HRQoL scores at 12 months after treatment” = −1.93-4.64) | |
Role and emotional functioning | Anxiety: State Trait Anxiety Inventory (STAI) | No differences between groups for all other secondary outcomes (all p values > 0.05) | ||
Feelings of control and anxiety | Perceived feelings of control: Mastery scale | |||
Kroenke et al. (2010) [26] | Centralized telecare management by a nurse-physican specialist team coupled with home-based symptom monitoring by interactive voice recording or internet | Depression and pain | Measured at baseline and at 1, 3, 6 and 12 months. Depression measured using the “20-item Hopkins Symptom Checklist (HSCL-20) and pain (BPI) severity | Greater improvements in pain (p < 0.001) and depression (p < 0.001) in the intervention group. |
Secondary outcomes: | Health related quality of life: SF-12 | Effect size “for between-group differences” at 12 months for pain were 0.39 (95% CI, 0.01-0.77) and for depression, 0.41 (95% CI, 0.08-0.72) | ||
Health-related quality of life | “Quality of life – single item 0-10” | No difference for health-related quality of life and health-care use. Difference for “other pain treatments” (p = 0.03). | ||
Disability | Anxiety – “7-item Generalised Anxiety Disorder scale” | |||
Cointerventions | “Physical symptom burden – 22-item somatic symptom scale” | |||
Self reported health care use | Fatigue- “SF 36 vitality scale” | |||
Disability – “3- item Sheehan Disability Scale” | ||||
“Self-report health care use: treatment survey” | ||||
Marcus et al. (2009) [18] | 16 session telephone counselling post treatment | Cancer specific Distress | Cancer specific Distress – Impact of Event Scale (IES). | No differences found for depression and distress unless end points were “dichotomized at cutpoints suggestive of the need for clinical referral”. A 50% reduction in depression and distress was demonstrated in the intervention group compared to the control. (p = 0.07) |
Depression | Depression – Centre for Epidermiologic Studies Depression Scale (CES-D) | “Significant effects” shown in sexual dysfunction and personal growth for the intervention group | ||
Sexual dysfunction | Sexual Dysfunction – 25 items (designed for study) | When endpoints dichotomized- no change in the control group (depression: p = 0.41, distress = 0.86). Intervention group (depression p = 0.0007, distress p = 0.0007) | ||
Personal Growth | Personal growth – 5 items (designed for study) | Group differences at 18 months were significant | ||
Depression: p = 0.06 and Distress: p = 0.07 “with effect sizes of 0.23 and 0.24” | ||||
Sexual dysfunction: at 18 months, “significant improvement intervention group” p = 0.04, effect size = 0.23 | ||||
Personal growth- both groups improved but more in the intervention group. (At 18 months p = 0.03, effect size =0.22) | ||||
Matthew et al. (2007) [20] | PDA survey followed by paper | Data quality | International Prostate Symptom Score (IPSS) | Internal consistency found to be high |
PDA followed by PDA survey. (3 groups) | Feasibility | Patient Orientated Prostate cancer Utility Survey (PORPUS) International Index of Erectile Function-5 (IIEF-5) either in paper or PDA forms | Test re-test reliability high. (p < 0.01) | |
Scores across modalities were correlated demonstrating “concurrent validity (p < 0.01)” | ||||
No differences in levels of participation | ||||
Preference was highest for the PDA version of the questionnaire. (58.6%) | ||||
Age did not have an impact on preference (p = 0.12) | ||||
Age did not have an impact of difficulty using PDA. (p = 0.08) | ||||
Confidence intervals quoted in the paper for each of the data items within the questionnaire | ||||
Sandgren et al. (2003) [19] | 6×30 min telephone therapy sessions that involved either cancer education or emotional expressions | Mood | Quality of Life – Functional Assessment of Cancer Therapy-Breast Instrument (FACT-B) | Cancer Education group – greater perceived control (p < 0.01) |
Quality of Life | Mood – Profile of Mood States | No difference for mood (p > 0.12) or quality of life (p > 0.12) found | ||
Perceived control | Perceived control – Perceived Stress Scale | No CIs quoted- only standard deviations, means and p values | ||
Sikorskii et al. (2007) [22] | Automated telephone symptom management | Severity of symptoms | 17 symptoms scored for severity – designed for the study. Analysed using a RASCH model | Both groups had a reduction in symptom severity. No difference found between 2 groups |
Effect sizes were almost the same for NASM (0.56) and ATSM (0.59) | ||||
Sikorskii et al. (2009) [23] | Automated voice response symptom reporting | Severity of symptoms – difference depending on mode of assessment | 14 cancer related symptoms – scored for severity. Designed for the study | AVR group reported more severe symptoms of “nausea, vomiting, diarrhoea, poor appetite, pain and alopecia (p values less than 0.05)” |
Varied with age with older patients reporting higher severity in the nurse led group (effect sizes greater or equal to 0.35”) | ||||
Yun et al. 2012 Seoul, Korea [24] | Internet based, individually tailored cancer related fatigue education program | Level of fatigue | Brief Fatigue Inventory (BFI) | Intervention group reported an improvement in fatigue with a significantly greater decrease in BFI global score (−0.66 points, 95% CI −1.04 to −0.27), FSS total score (−0.49;95% CI, 0.78 to −0.21) and HADS score |
Anxiety and depression | Fatigue Severity Scale (FSS) | Participants with moderate or greater fatigue reported a significantly greater decrease in HADS Anxiety score (−0.90; 95%CI, −1.51 to −0.29) as well as global quality of life (5.22; 95% CI, 0.93 to 9.50) and several functioning scores of the EORTC QLQ_C30 | ||
Global quality of life | Hospital Anxiety and Depression Scale (HADS) | |||
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ_C30) |