Pain Coping Skills and Meaning-Centered Intervention

Study Overview
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Brief Summary
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The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention. The second aim is to test the intervention's feasibility and acceptability as well as preliminary efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life) and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life. Participants will be patients with advanced cancer and moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will be intervention development. The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy. Initial intervention content will be further informed by interviews with patients with advanced cancer. Content will then be refined through an iterative patient testing process. Phase II of the study will be a single-arm pilot trial testing the intervention. The intervention will be delivered in-person and consist of four, 45-to-60 minute therapy sessions delivered using videoconferencing technology. Study measures will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks post-intervention (9 weeks).

Detailed Description
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Effective pain management is a major healthcare concern for patients with advanced cancer. Compared to patients with early-stage disease, those with advanced cancer report higher levels of pain and greater functional impairment related to pain. There is a critical need for psychosocial pain management interventions that are specifically designed to address the suffering of patients with advanced cancer. The proposed study seeks to develop and assess the feasibility, acceptability, and preliminary efficacy of a novel integration of pain coping skills training and meaning-centered psychotherapy for patients with advanced cancer and moderate-to-severe pain.

Official Title
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Pain Coping Skills Training and Meaning-Centered Intervention for Cancer Pain

Conditions
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Advanced Cancer, Pain

Intervention / Treatment
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* Behavioral: Pain Coping Skills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis At least moderate pain (pain score >/= 4) at recruitment Clinically elevated distress (NCCN Distress Thermometer >/= 3) at recruitment Eastern Cooperative Oncology Group (ECOG) </= 2 at recruitment Ability to speak and read English Exclusion Criteria: Brain tumor diagnosis Significant cognitive impairment Serious mental illness that would interfere with engagement in the intervention (e.g., schizophrenia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Coping Skills<br> | Behavioral: Pain Coping Skills<br>* Participants will be trained in pain coping skills and meaning-centered psychotherapy. The intervention will consist of 4 weekly videoconference-delivered sessions that will last between 45 and 60 minutes.<br>* Other names: Meaning-Centered Psychotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by study accrual | Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm trial) in the 24-month study period. | 5 weeks (immediately post-intervention) | 
| Feasibility as measured by study attrition | Treatment feasibility will be shown by no more than 30% study attrition. Attrition will be defined as not completing the post-intervention assessment. | 5 weeks (immediately post-intervention) | 
| Acceptability as measured by the Client Satisfaction Questionnaire eight-item version (CSQ) | Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol (mean score of 7) on the CSQ. | 5 weeks (immediately post-intervention) | 
| Acceptability as measured by engagement | Acceptability will be indicated by reported practice of the skills and ideas from the intervention in at least 75% of the sessions. | 3 weeks, 4 weeks, and 5 weeks (sessions 2, 3, and 4) | 
| Change in pain and pain interference | Pain and pain interference will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in meaning in life | Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp). | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-efficacy for pain management | Self-efficacy for pain management will be measured using the five-item self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale. | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in anxiety | Anxiety will be measured using the seven-item version of the Generalized Anxiety Disorders scale (GAD-7). | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in depressive symptoms | Depressive symptoms will be measured using the eight-item version of the Patient Health Questionnaire (PHQ-8). | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in hopelessness | Hopelessness will be measured using the eight-item Hopelessness Assessment in Illness Questionnaire. | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in fatigue | Fatigue will be assessed using the four-item Fatigue Symptom Inventory (FSI). | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in health-related quality of life | Health-related quality of life will be assessed using the 16-item version of the McGill Quality of Life Questionnaire. | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in performance status | Performance status will be assessed using the one-item self-report version of the Karnofsky Performance Rating Scale. | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) | 
| Change in meaningfulness in life despite pain | Meaningfulness in life despite pain will be measured using the five-item Pain Solutions Questionnaire - Meaningfulness in Life Despite Pain subscale. | 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention) |