1. Introduction
Pain is common for patients with cancer. Moderate-to-severe pain is endorsed by nearly 40% of patients with cancer and affects patients' quality of life and health outcomes.15,37 Analgesics are an effective first-line treatment for cancer pain,34,36 yet undertreatment remains common, with one-third of patients reporting inadequate pain management.8 National guidelines recommend integrating psychosocial and pharmacologic interventions for optimal cancer pain management.27,34 Psychosocial interventions, such as behavioral pain management, are efficacious for reducing pain.29 However, optimal dosing of behavioral pain interventions is not known, and integration of these interventions remains low.
Pain Coping Skills Training (PCST) is a behavioral pain management intervention that has demonstrated efficacy in numerous clinical populations.1,2,5,10,26,31–33,38 Pain Coping Skills Training protocols teach patients cognitive–behavioral skills to enhance their pain self-management. Traditional randomized controlled trials of PCST have used a “one size fits all” approach with all participants receiving the same intervention, and outcomes are assessed postintervention. This approach is discordant with clinical practice, where intervention response is repeatedly assessed, and dose is adapted based on response.
This study used a Sequential Multiple Assignment Randomized Trial (SMART)19,24 design to evaluate whether varying doses of PCST and response-based dose adaptation can improve pain in women with breast cancer. The first aim assessed comparative evidence of pain severity response to differing initial doses expecting that participants randomized to PCST-Full would report a significantly greater reduction in pain severity compared with participants randomized to PCST-Brief. The second aim was to provide comparative evidence of pain response to entire dose sequences of PCST, which adjusted the second dose based on participant response to initial dose.
2. Methods
2.1. Study sample
A trial methods description has been published.12 Procedures were approved by Duke University (IRB No. Pro00070823) and complied with Health Insurance Portability and Accountability Act guidelines. Participants were recruited between November 2016 and October 2020 from the Duke Cancer Center (Durham, NC; N = 123), Duke Women's Cancer Care Raleigh (N = 199), and a clinic in the Duke Cancer Network (Henderson, NC; N = 5). Potentially eligible participants were identified by medical record review, provider referral, or self-referral. After the oncologist approval, research staff mailed a letter followed by a telephone call or clinic approach, completed screening, and obtained informed consent. Eligibility criteria included (1) stage I-IIIC breast cancer3 (initial or recurrence) within 2 years, (2) 18 years or older, (3) life expectancy >12 months, and (4) worst pain severity in past week >5 of 10 at screening.28 Exclusion criteria included (1) cognitive impairment,7 (2) severe psychiatric condition, and (3) PCST in the past 6 months.
2.2. Design
Figure 1 presents the 8 intervention sequences embedded and compared in the SMART design. After baseline assessment, participants were randomly assigned (1:1 allocation) to a five session PCST-Full or a one session PCST-Brief. Randomization was performed by an independent staff member. Participants were not blinded to condition, given that conditions had differing numbers of sessions. Study therapists were blinded to participants' assessment responses, and analyses were conducted by team members who did not interact with participants. Five to 8 weeks after randomization (assessment 2), pain severity was assessed. Those who responded to the initial intervention (ie, pain severity reduction >30%)16 were rerandomized to a maintenance dose (ie, PCST-Full Maintenance or PCST-Brief Maintenance) or no further intervention. Those who did not respond were rerandomized to an increased dose (ie, PCST-Plus or PCST-Full) or a maintenance dose (ie, PCST-Full Maintenance or PCST-Brief Maintenance). Assessment 3 was completed 5 to 8 weeks after rerandomization, and assessment 4 was completed 6 months after assessment 3. Sequential Multiple Assignment Randomized Trials are ideal for studying outcomes following entire intervention sequences that may adjust or modify an initial intervention based on response, where a sequence specifies a strategy for treating a patient over time.17,35 Supplemental Online Figure 1 (available at https://links.lww.com/PAIN/B812) presents this process.
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Figure 1.: Eight intervention sequences embedded in the SMART design. PCST, Pain Coping Skills Training; SMART, Sequential Multiple Assignment Randomized Trial.
2.2.1. Initial randomization conditions
- (1) Pain Coping Skills Training-Full (PCST-Full). Pain Coping Skills Training-Full consisted of five 60-minute weekly individual in-person sessions. Sessions focused on pain education22,23 and training in cognitive–behavioral pain management skills using behavioral rehearsal, modeling, guided practice, and feedback. Session one focused on training in progressive muscle relaxation and guided imagery.16,30 Subsequent sessions included training in activity–rest cycling, pleasant activity scheduling, applied relaxation, identifying and changing unhelpful pain-related thoughts, problem solving, and goal setting.9,14
- (2) Pain Coping Skills Training-Brief (PCST-Brief). Pain Coping Skills Training-Brief consisted of one 60-minute individual in-person session. Session content was the same as the PCST-Full first session.
Participants in both initial conditions received 3 weekly caring text messages to prompt skills practice and provide encouragement.
2.2.2. Secondary/rerandomization conditions
- (3) Pain Coping Skills Training-Plus after PCST-Full Nonresponse. Participants received 2 additional in-person sessions focused on skills practice emphasizing adherence followed by three weekly 20-minute telephone calls to review skills practice, problem solving, and assess progress.
- (4) Pain Coping Skills Training-Full Maintenance after PCST-Full Nonresponse. Participants received 5 weekly 20-minute booster telephone calls to review skills practice, problem solving, and do a therapist-guided relaxation practice using techniques learned in the initial randomization condition.
- (5) Pain Coping Skills Training-Full Maintenance after PCST-Full Response. Participants received the same secondary condition as described in #4.
- (6) No Further Intervention after PCST-Full Response. Participants received no further intervention.
- (7) Pain Coping Skills Training-Full after PCST-Brief Nonresponse. Participants received the condition described in #1.
- (8) Pain Coping Skills Training-Brief Maintenance after PCST-Brief Nonresponse. Participants received 5 weekly 20-minute booster telephone calls to problem solving and practice therapist-guided PMR or imagery.
- (9) Pain Coping Skills Training-Brief Maintenance after PCST-Brief Response. Participants received the same secondary condition as described in #8.
- (10) No Further Intervention after PCST-Brief Response. Participants received no further intervention.
2.3. COVID-19 pandemic
After March 13, 2020, procedures were conducted through telephone because of the COVID-19 pandemic. Overall, 13.5% (44/327) of participants had at least one intervention session during the pandemic. There were no differences in response to PCST-Full or PCST-Brief based on delivery modality (χ2 = 0.03 and 0.23, respectively; P > 0.05).
2.4. Therapist training and treatment fidelity
Therapist training included a 2-day workshop and a 4-week certification process. Therapists were intervention certified after demonstrating >90% (M = 4.50/5.00) competence and adherence. The five study therapists (ie, PhD-level clinical psychologists and one advanced PhD clinical psychology student) received weekly supervision. Of 326 participants assigned to a therapist and 1804 total study sessions: Therapist 1 = 150 participants, 47% of sessions; Therapist 2 = 148 participants, 43% of sessions; Therapist 3 = 23 participants, 8% of sessions; Therapist 4 = 4 participants, 2% of sessions; and Therapist 5 = 1 participant, 0.2% of sessions. Intervention response differences between therapists were considered by comparing Therapist 1 and Therapist 2 as well as Therapist 1, Therapist 2, and the other 3 therapists combined. There were no significant differences in response at any time point by the therapist (P = 0.31-0.94).
Treatment fidelity was assessed by an independent PhD-level clinical psychologist. Twenty percent of session recordings (N = 108) were randomly reviewed. Competence and adherence were exceptional, with average ratings of 4.71 (SD = 0.28) and 4.75 (SD = 0.44), respectively.
2.5. Study measures
Participants completed standardized self-report measures online at assessments 1 to 4 receiving $30 for each assessment. Participant demographics and medical variables were collected at assessment 1.
2.5.1. Primary outcome
Pain severity was assessed with the Brief Pain Inventory (BPI)—Pain Severity subscale.4 Participants rated their pain over the past 7 days at its worst, least, and average as well as their current pain where 0 = no pain to 10 = worst pain imaginable (Cronbach α = 0.86). The primary outcome was percent change in pain severity from assessment 1 to assessment 2, calculated using the following formula: {([average of BPI severity items at assessment 2 − average of BPI severity items at Assessment 1]/average of BPI severity items at assessment 1) × 100}. Given this formula, negative values correspond to a pain reduction.
2.5.2. Initial intervention response
Response was categorized as follows: responders reported >30% reduction in their pain severity and nonresponders reported <30% reduction or a pain severity increase.
2.5.3. Intervention outcomes
Percent change in pain severity from assessment 1 to assessment 3 was calculated using {([average of BPI severity items at Assessment 3 − average of BPI severity items at Assessment 1]/average of BPI severity items at Assessment 1) × 100}. Similarly, percent change in pain severity from assessment 1 to assessment 4 was calculated using {([average of BPI severity items at Assessment 4 − average of BPI severity items at Assessment 1]/average of BPI severity items at Assessment 1) × 100}.
2.6. Sample size
An effective sample size of 284 was planned (N = 327 allowing for approximately 15% attrition) to provide 80% power to detect a 10% mean difference in the primary outcome of percent reduction in pain severity from assessment 1 to assessment 2 between PCST-Full and PCST-Brief assuming a standard deviation 30% in each group at a 0.05 two-sided level of significance.
2.7. Statistical analyses
To test the first aim, an average percent reduction in pain severity at assessment 2 between the 2 initial intervention conditions was compared (ie, PCST-Full vs PCST-Brief) using a standard 2-sided, 2-sample t test.
To test the second aim, the mean percent reduction in pain for each of the 8 intervention sequences embedded in the SMART at assessment 3 and assessment 4 was estimated and compared using specialized methods21,24,25 that take into account that the interventions received by a participant may be consistent with having followed more than one of the sequences. Specifically, a modification of the approach by Nahum-Shani et al.25 was applied using weights based on sample proportions randomized at each stage in place of known randomization probabilities (0.5 at each stage), which statistical theory leads to more precise estimators and more powerful tests.35 A χ2 statistic constructed from these estimates was the basis for a test of the null hypothesis of no difference in mean percent reduction in pain. Planned comparisons of pairs of sequences reflecting the least and most intensive approaches overall (sequences 1 and 8) and within each initial intervention (sequences 1 and 4 and sequences 5 and 8) were conducted using constructed Z statistics.
3. Results
3.1. Study participants and intervention adherence
Figure 2 presents randomization, response, and rerandomization details. Withdrawals were minimal (29/327; 8.9%) and consistent between initial randomization groups (χ2 = 0.03; P = 0.859). Table 1 presents participant (N = 327) characteristics. Pain Coping Skills Training-Full participants (n = 163) completed on average 4.33 (SD = 1.40) sessions with 77% completing all five sessions; 99% of PCST-Brief participants completed their session. In the second conditions, participants rerandomized to PCST-Full (n = 44) completed on average 3.75 (SD = 1.94) sessions with 64% completing all 5 sessions; participants rerandomized to PCST-Plus (n = 36) completed on average 1.53 (SD = 0.84) sessions with 75% completing both sessions. Across conditions with phone calls, 62% to 82% of participants completed all calls. Daily skills practice was assessed at assessments 2, 3, and 4 by asking participants how many times in the past 7 days they had used PCST skills (0 = not at all, 1 = one time, 2 = a few days, 3 = several days, 4 = almost every day, and 5 = every day). Across follow-up time points, participants reported using skills on average “several days” or “almost every day” in the past 7 days. Supplement Table 1, available at https://links.lww.com/PAIN/B812, presented reported means and standard deviation of skills practice at each assessment overall and by randomization condition.
Figure 2.: Consort chart. PCST, Pain Coping Skills Training.
Table 1 -
Participant demographic, medical characteristics, and pain at baseline.
| Characteristic |
Overall (N = 327) |
PCST-Full (n = 163) |
PCST-Brief (n = 164) |
| Age, y, mean (SD) |
57.19 (11.87) |
56.93 (11.96) |
57.45 (11.81) |
| Race |
|
|
|
| Caucasian |
203 (62) |
98 (60) |
105 (64) |
| Black or African American |
97 (30) |
52 (32) |
45 (27) |
| Other (eg, Asian) |
22 (7) |
11 (7) |
11 (7) |
| Declined |
5 (2) |
2 (1) |
3 (2) |
| Not Hispanic or Latina |
311 (95) |
155 (95) |
156 (95) |
| Married/living with partner |
195 (60) |
94 (58) |
101 (62) |
| Bachelor's or graduate degree |
173 (53) |
81 (50) |
92 (56) |
| Months since diagnosis, mean (SD) |
10.11 (6.21) |
9.85 (5.91) |
10.37 (6.49) |
| Stage at diagnosis |
|
|
|
| I |
183 (56) |
95 (58) |
88 (54) |
| II |
113 (35) |
52 (32) |
61 (37) |
| III |
31 (9) |
16 (10) |
15 (9) |
| Surgical history* |
|
|
|
| Single mastectomy |
54 (17) |
36 (22) |
18 (11) |
| Double mastectomy |
65 (20) |
28 (17) |
37 (23) |
| Breast conserving (eg, lumpectomy) |
185 (57) |
94 (58) |
91 (56) |
| Lymph node removal or dissection |
286 (88) |
145 (90) |
141 (87) |
| Breast reconstruction |
73 (23) |
39 (24) |
34 (21) |
| Treatment in past week* |
|
|
|
| Surgical procedure |
22 (7) |
10 (6) |
12 (7) |
| Chemotherapy |
27 (8) |
12 (7) |
15 (9) |
| Radiation |
35 (11) |
15 (9) |
20 (12) |
| Immunotherapy |
31 (10) |
15 (9) |
16 (10) |
| Endocrine therapy |
49 (15) |
25 (15) |
24 (15) |
| Clinical trial |
4 (1) |
3 (2) |
1 (1) |
| Pain medication use* |
|
|
|
| Over the counter |
177 (54) |
87 (53) |
90 (55) |
| Opioid |
60 (18) |
31 (19) |
29 (18) |
| Other medications used for pain† |
107 (33) |
50 (31) |
57 (35) |
| Pain severity (0-10), mean (SD)* |
4.04 (1.73) |
4.03 (1.81) |
4.04 (1.65) |
Data are presented as no. (%) or n of N (%) unless indicated otherwise.
*Total n between 323 and 326 for these data points.
†Other self-reported medications for pain included corticosteroids, anticonvulsants, Lyrica, anxiolytics, antidepressants, anti-inflammatory, and muscle relaxants.
PCST, Pain Coping Skills Training; PCST-Full, five intervention sessions; PCST-Brief, one intervention session.
3.2. Aim 1
Aim 1 examined the average percent reduction in pain severity from assessment 1 to assessment 2 by initial randomization condition. Overall, there was a decrease in mean pain severity from assessment 1 to assessment 2 (Assessment 1 M [SD] = 4.0 [1.7]); Assessment 2 = 2.9 (1.8). As hypothesized, PCST-Full led to a greater mean percent reduction in pain than PCST-Brief (M [SD] = −28.5% [39.6%] vs M [SD] = −14.8% [71.8%], difference [SE] = −13.7% [6.7%], 95% confidence interval [CI] [−26.8% to −0.6%], P = 0.041). In examining the minimal clinically important difference (MCID; >30%) for pain severity, 51.0% of PCST-Full participants and 42.3% of PCST-Brief participants reported at least a 30% reduction in pain severity after their initial intervention assignment (P = 0.127).
3.3. Aim 2
Aim 2 compared the 8 intervention sequences embedded in the SMART study design (Fig. 1) by examining mean percent pain reduction from assessment 1 to assessment 3 and assessment 1 to assessment 4.21,24,25 Analyses included participants with available data at assessment 3 (n = 299) and assessment 4 (n = 291). The estimated mean percent reduction in pain by intervention sequence at assessment 3 and assessment 4 is presented in Table 2, along with the estimated mean percent reduction in pain at assessment 2 reported above (n = 307) after PCST-Full (the initial intervention for sequences 1-4) and PCST-Brief (the initial intervention for sequences 5-7).
Table 2 -
Estimated mean percent reduction in pain by intervention sequence compared with assessment 1 at assessment 3 and assessment 4, with estimated mean percent reduction in pain compared with assessment 1 at assessment 2 for Pain Coping Skills Training-Full (initial intervention for sequences 1-4) and Pain Coping Skills Training-Brief (initial intervention for sequences 5-8).
| Sequence |
Estimated mean (SE)
(95% CI)
A2 |
Estimated mean (SE)
(95% CI)
A3 |
Estimated mean (SE)
(95% CI)
A4 |
| S1 |
|
−30.0% (7.0%)
(−43.8% to −16.3%) |
−38.5% (6.2%)
(−50.6% to −26.3%) |
| S2 |
−28.5% (3.2%)
(−34.7% to −22.3%) |
−27.8% (6.8%)
(−41.1% to −14.5%) |
−31.7% (6.1%)
(−43.7% to −19.8%) |
| S3 |
|
−39.2% (4.5%)
(−48.1% to −30.3%) |
−41.8% (4.6%)
(−50.8% to −32.8%) |
| S4 |
|
−37.0% (4.2%)
(−45.2% to −28.7%) |
−35.1% (4.5%)
(−43.8% to −26.3%) |
| S5 |
|
−33.85 (4.8%)
(−42.9% to −24.2%) |
−37.1% (5.2%)
(−47.3% to −26.9%) |
| S6 |
−14.8% (5.8%)
(−26.3% to −3.4%) |
−37.9% (4.2%)
(−46.2% to −29.6%) |
−29.9% (5.5%)
(−40.7% to 19.0%) |
| S7 |
|
−20.1% (6.2%)
(−32.3% to −8.0%) |
−20.8% (7.1%)
(−34.7% to −7.0%) |
| S8 |
|
−24.6% (5.9%)
(−36.0% to −13.1%) |
−13.6% (7.2%)
(−27.7% to 0.6%) |
95% CI, 95% confidence interval.
At assessment 3, the evidence of differences among sequences was inconclusive (P = 0.11). All sequences show an improvement in estimated mean percent reduction in pain over that achieved by the initial intervention in the sequence at assessment 2 (Table 2), suggesting that the effect of the initial intervention may be enhanced over time and by dose adjustment. At assessment 4, however, there was strong evidence that all sequences are not the same in mean percent pain reduction from assessment 1 (P = 0.027). Any sequence that started with PCST-Full exhibited at least a 30% estimated mean reduction in pain at assessment 4, while only 2 of the four sequences that started with PCST-Brief achieved this effect (Table 2). The least intensive, sequence 8, showed the smallest mean percent pain reduction at assessment 4.
Comparison of the most and least intensive sequences overall (sequences 1 and 8) did not demonstrate the evidence of a difference in mean percent reduction in pain from assessment 1 to assessment 3 (difference [SE] = −5.5% [9.1%], 95% CI [−23.5% to 12.4%], P = 0.55). Similarly, there was not sufficient evidence at assessment 3 of a difference between the most and least intensive sequences starting with PCST-Full (sequences 1 and 4; difference [SE] = 6.9% [8.1%], 95% CI [−8.9% to 22.7%], P = 0.39) nor between those starting with PCST-Brief (sequences 5 and 8) (difference [SE] = −9.0% [7.4%], 95% CI [−23.6% to 5.6%], P = 0.23). However, at assessment 4, evidence supporting differences was found between sequence 1 and sequence 8 (difference [SE] = −24.9% [9.5%], 95% CI [−43.5% to −6.3%], P = 0.009) and sequences 5 and 8 (difference [SE] = −23.6% [8.7%], 95% CI [−40.7% to −6.5%], P = 0.007), but not between sequences 1 and 4 (difference [SE] = −3.4% [7.5%], 95% CI [−18.1% to 11.3%], P = 65).
Supplemental Tables 2, 3, and 4 (available at https://links.lww.com/PAIN/B812) present additional analyses providing insights into the evolution of mean percent pain reduction between assessments 3 and 4 for each sequence. Analyses suggest that sequences starting with PCST-Full might achieve durable, meaningful mean percent reduction in pain from assessment 3 to 4. Analyses comparing mean percent reduction in pain from assessment 1 to assessments 3 and 4 for PCST-Full vs PCST-Brief, marginalizing over subsequent interventions, also suggest sequences starting with PCST-Full may yield greater mean reduction in pain by assessment 4.
4. Discussion
Guidelines recommend routine integration of behavioral cancer pain interventions,34,36 yet little is known about optimizing these approaches. This trial rigorously examined behavioral pain intervention dosing in women with breast cancer and pain. As hypothesized, after initial randomization, PCST-Full participants reported significantly reduced pain severity compared with PCST-Brief participants (29% vs 15% reduction). Pain Coping Skills Training-Full led to an average pain reduction that approached being clinically meaningful6 (ie, >30% pain reduction), whereas PCST-Brief did not. Among PCST-Full participants, 51% reported a clinically meaningful pain severity reduction. Promisingly, and not statistically significantly different from PCST-Full, 42% of PCST-Brief participants also experienced a meaningful pain reduction.
Second doses of PCST that were adjusted based on response to the initial dose were examined. Based on the intervention sequence outcomes after the second intervention dose (approximately 4 months from baseline), participants demonstrated statistically significant average pain severity reduction from baseline. Response across sequences varied from 20% to 40%, with five of the 8 sequences resulting in clinically meaningful pain decreases (ie, >30%; Table 2). Although there were significant differences in mean percent reduction of pain severity between PCST-Full and PCST-Brief after the initial doses, there were no significant differences in pain severity at 4 months among sequences after the second dose. Thus, secondary PCST response-based dosing may be a strategy to improve pain severity outcomes.
At the 6-month follow-up, 6 of the 8 PCST intervention sequences demonstrated strong durability of response from immediately post-treatment. Specifically, 10 months after baseline, 7 of 8 intervention sequences continued to demonstrate statistically significant pain severity reductions (21%-42%), whereas one did not (14%), and 6 of 8 continued to demonstrate clinically meaningful pain severity reduction (ie, >30%). Pain reduction maintenance in response to a behavioral pain intervention at the long-term follow-up in a cancer population suggests that dose adjustment based on individual response or needs can lead to improved longitudinal outcomes. Many behavioral intervention trials have often had shorter follow-up periods and demonstrated a regression to the mean or baseline levels of symptoms.20,29
The intervention sequences that demonstrated durable pain reduction at the final time point included PCST-Full either as an initial dose or a secondary dose. The intervention sequences that demonstrated the least durability started with PCST-Brief, followed by PCST-Brief Maintenance or nothing (ie, sequences 7 and 8). The lowest dosing sequence showed a decrease in the maintenance of pain reduction from immediately postintervention to the final time point (25% to 14% reduction). Pain Coping Skills Training-Full included 8 different coping skills, while PCST-Brief included just 2 relaxation-focused skills. The full cadre of pain coping skills may be optimal for extended pain relief.
This study met a high accrual goal, had high adherence, and had high participant retention (91% completion) even within the context of a complicated trial design and the COVID-19 pandemic. This work also has areas for improvement. Of note, generalizability is limited as this study was conducted at a well-resourced single institution with well-trained staff and was delivered mostly in-person by experienced therapists. In addition, the focus on pain as an outcome limits our understanding of how decreases in pain may be related to other outcomes (eg, quality of life). Finally, PCST skills use in daily life is an important adherence variable and was not quantified but is important dosing data and likely could be collected through simple electronic data collection such as text messaging. These limitations can and should be addressed in future work (eg, effectiveness trial and broader assessment).
Multistage designs, such as SMARTs, are useful for testing and refining interventions to approximate actual clinical practice.24,25 Both initial PCST doses led to a clinically meaningful pain reduction in 51% (PCST-Full) and 42% (PCST-Brief) of participants; in 7 of 8 sequences, these reductions steadily improved or were maintained longitudinally. Pain Coping Skills Training is a nonpharmacological pain intervention, and varying PCST doses seem to lead to pain reduction. Pain Coping Skills Training protocols have the potential to be readily disseminated as they are manualized and brief and include relaxation and imagery (2 central skills) in audio form. Pain Coping Skills Training protocols can be efficaciously delivered either in-person or through telehealth,11 as well as delivered by several trained healthcare providers18 increasing accessibility particularly in areas with limited resources.13 Increasingly automating these protocols (eg, app, web-based, video) and enhancing the maintenance of the brief doses (eg, identify potent skills, practice reminders, motivational interviewing, and continued contact) could further intervention reach and decrease costs.
Conflict of interest statement
The authors have no conflicts of interest to declare.
Appendix A. Supplemental digital content
Supplemental digital content associated with this article can be found online at https://links.lww.com/PAIN/B812.
Acknowledgements
This work was funded by an award from the National Institutes of Health (R01CA202779) to the first author (T.J. Somers).
Contributors: Conceptualization: T.J. Somers, F.J. Keefe, M. Davidian, S.D. Reed; Data curation: J.G. Winger, S.N. Miller; Formal Analysis: J.G. Winger, M. Davidian, E.B. Laber; Funding acquisition: T.J. Somers; Investigation: S.A. Kelleher, J.C. Plumb Vilardaga, C. Majestic; Methodology: T.J. Somers, M. Davidian, E.B. Laber; Project administration: S.N. Miller; Resources: S.N. Miller; Visualization: T.J. Somers, J.G. Winger; Writing—original draft: T.J. Somers, J.G. Winger, H.M. Fisher, K.A. Hyland; Writing—review and editing: T.J. Somers, J.G. Winger, H.M. Fisher, K.A. Hyland, M. Davidian, E.B. Laber, S.N. Miller, S.A. Kelleher, J.C. Plumb Vilardaga, C. Majestic, R.A. Shelby, Shelby D. Reed, G.G. Kimmick, F.J. Keefe.
Data availability: We will work with the Palliative Care Research Cooperative to deposit de-identified data in their de-identified quantitative data repository.
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