Qualitative inquiry: a method for validating patient perceptions of palliative care while enrolled on a cancer clinical trial

Participants (n = 34) in this qualitative analysis were drawn from a larger, randomized controlled, multiphased, longitudinal, mixed methods trial conducted at the National Institutes of Health (NIH), Clinical Center (CC) to evaluate the efficacy of the Palliative Care Service intervention compared to usual care for patients with advanced malignancies who were enrolled in cancer clinical trials that included undergoing surgical procedures in National Cancer Institute (NCI) Surgery Branch clinical trials. The primary study included 152 participants, 76 in the early palliative care arm and 76 in the standard care arm [ 10]. Participants from the primary study in the standard care arm were permitted to crossover to the treatment arm at the clinical discretion of the attending physician if pain and symptom management in the standard care arm was insufficient to meet their needs [ 10]. All 34 participants who received palliative care services and provided responses to the open-ended questions were included in the analysis. Of the 34 participants included in the qualitative analysis, 29 participants were enrolled in the treatment arm and 5 participants were crossovers from the standard care to the treatment arm of the study. The pain and palliative care team (PPCT) for this analysis included two full time attending physicians, three nurse practitioners, a nurse thanatologist, and one physician fellow from Hospice and Palliative Medicine [ 10]. In addition, patients also had access to spiritual ministry, social work, recreation therapy, counseling, nutrition, acupuncture, acupressure, massage, reiki, and rehabilitation medicine. Consults with the palliative care service included a full pain and symptom assessment, a review of treatments being implemented and any emotional or spiritual distress the patient may have been experiencing [ 10].

The original study was approved by the National Cancer Institute (NCI) institutional review board (IRB) [ 10]. All participants provided written informed consent. The qualitative analysis presented in this paper was further approved by the Office of Human Subjects Research Protection at the NIH and the University of Pennsylvania IRB. All qualitative data were de-identified prior to the qualitative thematic analysis.

Two open-ended qualitative questions related to the receipt of pain and palliative care services were included at 6 weeks, 6 months, and 12 months. These open-ended questions were as follows: 1) Do you feel that you are more likely or less likely to complete the protocol knowing that the Pain and Cancer teams are working together? Can you put into words your sense of security (with having a pain and palliative care team)? 2) What is your perception of how the Cancer Institute and the Pain and Palliative Care Service are communicating? Do you think that the communication is working to help you? These qualitative open-ended questions were part of a semi- structured, face-to-face interview conducted by a nurse researcher in an outpatient surgical oncology clinic. All sessions were audio-taped and transcribed verbatim.

Thematic analyses of verbatim transcripts of audio files were conducted by two independent readers (CS, CM-D). For validity, all transcripts were independently reviewed by the readers, followed by an independent blinded review by the principal investigator (GW). The themes were then condensed and verified by the analysis team (CS, CM-D, GW) in a joint meeting, and consensus building by all readers. Verification of the themes occurred throughout the data analysis process in order to establish methodological rigor [ 11]. The qualitative analysis program NVivo 7 was utilized by the readers to manage and cross-reference participant responses.

Figures  1 and 2 illustrate the process by which the overarching themes were developed. First, the independent readers (CS, CM-D) conducted an initial content analysis of all 34 transcribed interviews from the two open-ended questions based on their content and perceived importance. The initial content analysis by the independent reviewers was then analyzed by the PI of the primary investigation (GW) for completeness and consistency of participants’ meanings throughout analysis. Second, the independent readers assembled themes and subthemes in NVivo 7 from the verbatim transcripts by merging similar codes, combining repetitive or overlapping codes, and merging the independent coding lists of the two readers. The initial theme list addressed responses to the question: Do you feel that you are more likely or less likely to complete the protocol knowing that the Pain Team and the Cancer team are working together? Can you put into words your sense of security? Codes were combined into 25 themes, which all represented a collection of the codes identified by the reviewers, with none eliminated to ensure the inclusion of all data for the next step in analysis. Next, the reviewers met and conducted the first round of consensus building by the independent readers and principal investigator. Themes that were viewed as repetitive were eliminated. Themes that appeared to overlap between the independent reviewers were merged. Of the original 25 themes, 12 remained. Next, the team addressed the second open-ended question: What is your perception of how the Cancer Institute and the Pain and Palliative Care Service are communicating? Do you think that the communication is working to help you? Thematic analysis for the second question was the same as the first; the initial theme list included 30 themes. After consensus building, 27 themes illustrated the merged and eliminated themes between reviewers. To support the second criterion of dependability, the initial content analysis by the independent reviewers was then analyzed by the PI of the primary study (GW) as a review for the consistency of participants’ meanings throughout the analysis. Following these steps, two debriefing sessions were held with the three reviewers (CS, CM-D, GW) to establish consensus regarding major themes. The existing literature was also reviewed to establish validity [ 12, 13]. The independent reader (CS) assembled a table of patient quotations that was generated from the list of themes which was then reviewed by the rest of the research team (CM-D, GW, KB) for significance and accuracy.

Three themes emerged when asked whether receiving pain and palliative care services made them more likely to remain enrolled in their primary cancer clinical trial: 1) patients’ past experiences with care, 2) self-identified personal characteristics and reasons for participation, and 3) the quality of the cancer clinical trial team and palliative care team partnership (Table  2).

The patients’ past experiences with care influenced their willingness to participate and remain enrolled in their clinical trial. One participant described this perception of a “good feeling” that contributed to their willingness to return and remain enrolled in their cancer clinical trial.

‘I wouldn’t even consider coming back here if I didn’t have a good feeling about last time.’ (Time 2, 45 year old, female, melanoma).

Self-identified personal characteristics and reasons for participation also emerged from the data, including the motivation to help others as a reason to participate. As one participant described:

‘I feel that it’s important, not that it’s going to help me but that it’s going to help the next people. And you know I’m real happy with everything.’ (Time 3, 66 year old male, pseudomyxoma)

Some patients discussed perseverance as a self-identified personal characteristic that helped them feel confident enough to get through the clinical trial. Patients who made statements describing perseverance did so independently of what was happening with them in the trial. Patients were motivated to finish the trial no matter what, speaking to their persevering character rather than the challenges faced in the trial.

The quality of the partnership between the cancer clinical trial team and PPCT was an important theme that contributed to the patients’ likelihood of remaining in the clinical trial; it included the importance of being closely monitored, supported, having confident providers, and good pain management. Patients in the clinical trial viewed the close monitoring as a benefit of participating in the trial and a way of getting better treatment than if they did not participate. As a patient described:

‘Yeah, I think it’d be easier to complete the protocol and it’s always better to have more teams working together for the final outcome.’ (Time 2, 38 year old, male, renal cell cancer)

Another factor contributing to patients’ perspective of the quality of the team was the degree of support they received from the PPCT. This support by the PPCT involved acknowledging participants’ physical, emotional, and psychological needs and the ability of the PPCT to help participants cope with the burdensome parts of the protocol.

‘We believe that we’re in good hands.’ (Time 2, 65 year old, male, colon cancer)

‘ Absolutely, nobody minimized anything.’ (Time 2, 45 year old, female, colon cancer)

‘I feel their support.’ (Time 2, 49 year old, female, mucinous adenocarcinoma)

Separate from having their physical health monitored, participants also felt that the PPCT acted as their advocates. This was through their sense of connection with the PPCT and the perception that they aided in making informed decisions to improve not only participants’ physical health, but also their emotional and mental well-being.

Part of participants’ appreciation for a quality team was based on the display of confidence by the healthcare team themselves. Providers who relayed knowledge of the participants’ experiences and confidence in themselves were perceived as quality providers. As one participant stated:

‘They express so much confidence, you know. And I feel confident that they could do the job.’ (Time 3, 65 year old, male, colon cancer)

Another participant described the team’s knowledge as the reason for their confidence:

‘I think they realize different symptoms that I might not realize that I’m going through and they pick it up pretty fast.’ (Time 3, 53 year old, female, pseudomyxoma)

Four themes emerged related to interdisciplinary communication including: 1) developing relationships, 2) facilitating open communication, 3) having quality communication, and 4) uncertainty about communication between the cancer clinical trial team and the palliative care team (Table  3).

Developing relationships was important to participants as identified below.

‘I feel the communication with each other and I’m sure they understand. They relate to what I’m going through.’ (Time 2, 41 year old, male, melanoma)

Facilitating open communication is an important part of providing high quality care and helping participants feel secure, especially in PCCTs. Patients wanted to feel involved in the communication process and have information clearly articulated to them by the cancer clinical trial team, as noted by the following statement:

‘You know, what’s the best way, when we’re getting conflicting information from his primary care managers or the physical therapists down there to what they’re suggesting here. That what’s nice about having that Pain and Palliative Care Team conversing with them as to going outside of NIH and trying to make everybody on the same page. That’s the part that I don’t think can be avoided but that’s the hardest point.’ (Time 2, 48 year old, male, rectal cancer)

The PPCT’s expertise in communicating with participants about different aspects of their care gave the participants greater confidence in the PPCT. Consistent, quality information is crucial between interdisciplinary teams. Whether patients had a positive or negative view on communication between the health care teams was partly reliant on the quality of the communication.

‘Absolutely, this place is excellent, it couldn’t be no better communication wise, everything, I’ve had great treatment here, I just don’t believe you could be any better place than here for this treatment.’ (Time 3, 53 year old, male, melanoma)

Quality of communication was recognized by participants based on how they “felt” about the degree of communication occurring and the actual results that were incurred, such as appointments, effective treatments, and consistency in care.

Some participants were unaware of the communication between the PPCT and the clinical trial team, while others simply assumed that communication was occurring but were unable to speak to the degree of communication. Additionally, a few participants felt left out of the communication. As a whole, this qualitative analysis provides insight into the cancer patients’ perceptions regarding receiving pain and palliative care services while enrolled in a clinical trial.

As with any qualitative inquiry, during the process of analysis the authors may not have captured nuances of intonations and personal vernacular specific to the participants that may have provided even further nuances related to their experiences. This study was prospective, but future retrospective studies are required to explore family perceptions of clinical trial participation and the quality of communication between clinical trial and palliative care teams after the death of their loved one. This study was also limited in that we did not directly examine whether individuals who felt positively about communication and were satisfied with their palliative care services remained enrolled the cancer clinical trial. Future studies are needed to quantify whether there is a relationship between the early introduction of integrated palliative care services and retention in cancer clinical trials.