Pain Coping Skills and Meaning-Centered Intervention

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207360
• Other study ID #: Pro00083582
• Secondary ID: 130526-PF-17-054
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: February 11, 2020

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Cancer
• Pain

Intervention

Behavioral:
• Pain Coping Skills
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)