Meaning-Centered Pain Coping Skills Training for Cancer Pain

Study Overview
=================
Brief Summary
-----------------
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference (N=210) will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

Detailed Description
-----------------
Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize 210 patients to MCPC or enhanced usual care control. Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace. The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.

Official Title
-----------------
Meaning-Centered Pain Coping Skills Training: A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients

Conditions
-----------------
Advanced Solid Tumor, Pain

Intervention / Treatment
-----------------
* Behavioral: Meaning-Centered Pain Coping Skills Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage IV solid tumor cancer diagnosis Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower At least one clinical pain severity rating > 0 out of 10 in past month At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference T-score >/= 55) in the past week at telephone screening Ability to speak and read in English Age >/= 18 years. Exclusion Criteria: Significant cognitive impairment as indicated in medical chart or during telephone screening Serious untreated mental illness Primary brain cancer diagnosis Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy Enrollment in hospice at screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group [ECOG] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meaning-Centered Pain Coping Skills Training<br>Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain. | Behavioral: Meaning-Centered Pain Coping Skills Training<br>* The goal of this intervention is to help participants reduce pain interference so that they can engage with what gives them a sense of meaning, purpose, and peace.<br>|
| No Intervention: Standard Care<br>Information and referrals for free services available through the Duke Cancer Patient Support Program. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form | This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference. | 8-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form | This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference. | 12-week follow-up | 
| Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale | This 4-item measure assesses pain severity at its worst, least, and average over the past 7 days as well as current pain severity. Response options range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate worse pain severity. | 8-week follow-up and 12-week follow-up | 
| Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) | This 12-item measure references the past 7 days and includes an overall spiritual well-being score and three subscales: 1) meaning (i.e., reason for living, sense of meaning and purpose); 2) peace (i.e., feeling peaceful, sense of harmony within oneself); and 3) faith (i.e., finding strength and comfort in faith or spiritual beliefs). Response options range from 0 (not at all) to 4 (very much); two items are reverse coded. Higher scores indicate greater spiritual well-being. | 8-week follow-up and 12-week follow-up | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale | This 8-item measure assesses feelings of meaning and purpose, including having a good sense of what makes one's life meaningful, a sense that one's life is valuable and worthwhile, having clear goals and aims, feeling life one's life has meaning, significance, direction, fulfillment, and purpose. Response options range from 1 (strongly disagree or not at all) to 5 (strongly agree or very much). Higher scores indicate greater meaning and purpose. | 8-week follow-up and 12-week follow-up | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form | This 8-item measure assesses anxiety symptoms over the past 7 days, including fear, difficulty focusing on things other than anxiety, feeling overwhelmed by worries, feeling uneasy, nervousness, feeling the need for help with anxiety, feeling anxious, and feeling tense. Response options range from 1 (never) to 5 (always). Higher scores indicate worse anxiety. | 8-week follow-up and 12-week follow-up | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form | This 8-item measure assesses depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, hopelessness, depression, failure, unhappiness, nothing to look forward to, and difficulty improving mood. Response options range from 1 (never) to 5 (always). Higher scores indicate worse depressive symptoms. | 8-week follow-up and 12-week follow-up | 
| Chronic Pain Self-Efficacy Scale (CPS) | This 5-item measures assesses patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication. Response options range from 10 (not at all certain) to 100 (very certain). Higher scores indicate greater self-efficacy. | 8-week follow-up and 12-week follow-up | 
| Medical Outcomes Study Social Support Survey (MOS-SS) | This 8-item measure assesses how often someone was available to provide instrumental (i.e., practical) support and emotional support. Instrumental support includes having someone available if confided to bed, needing to visit a doctor, needing help preparing meals, and needing help with daily chores. Emotional support includes having someone available to have a good time with, turn to for suggestions, feel understood, and feel loved and wanted. Response options range from 1 (none of the time) to 5 (all of the time). Higher scores indicate greater social support. | 8-week follow-up and 12-week follow-up | 
| 5-item 5-level EuroQol Group (EQ-5D-5L) | This 5-item measure assesses health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The response options range from 1 to 5, with response choices that vary per question. Higher scores indicate worse health-related quality of life. | 8-week follow-up and 12-week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caner pain management, Psychosocial intervention, Spiritual aspects of coping with pain, Pain Coping Skills Training, Meaning-Centered Psychotherapy