Pain Coping Skills Training and Meaning-Centered Intervention for Cancer Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- Duke University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in pain and pain interference
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in pain and pain interference
Time Frame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
Pain and pain interference will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF).
Acceptability as measured by engagement
Time Frame: 3 weeks, 4 weeks, and 5 weeks (sessions 2, 3, and 4)
Acceptability will be indicated by reported practice of the skills and ideas from the intervention in at least 75% of the sessions.
Feasibility as measured by study accrual
Time Frame: 5 weeks (immediately post-intervention)
Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm trial) in the 24-month study period.
Acceptability as measured by the Client Satisfaction Questionnaire eight-item version (CSQ)
Time Frame: 5 weeks (immediately post-intervention)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol (mean score of 7) on the CSQ.
Change in meaning in life
Time Frame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
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).
Feasibility as measured by study attrition
Time Frame: 5 weeks (immediately post-intervention)
Treatment feasibility will be shown by no more than 30% study attrition. Attrition will be defined as not completing the post-intervention assessment.
Secondary Outcomes
- Change in anxiety(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in hopelessness(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in health-related quality of life(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in self-efficacy for pain management(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in performance status(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in fatigue(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in depressive symptoms(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))
- Change in meaningfulness in life despite pain(0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention))