Pain Coping Skills and Meaning-Centered Intervention

NCT03207360 | Completed

• 2 other identifiers: Pro00083582130526-PF-17-054-01-PCSM
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Cancer; Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Change in self-efficacy for pain management

  0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

• Change in anxiety

  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 hopelessness

  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)

Study Arms (1)

Pain Coping Skills

EXPERIMENTAL

Behavioral: Pain Coping Skills

Interventions

Pain Coping Skills BEHAVIORAL

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.

Also known as: Meaning-Centered Psychotherapy

Pain Coping Skills

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Brain tumor diagnosis
• Significant cognitive impairment
• Serious mental illness that would interfere with engagement in the intervention (e.g., schizophrenia)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Winger JG, Ramos K, Kelleher SA, Somers TJ, Steinhauser KE, Porter LS, Kamal AH, Breitbart WS, Keefe FJ. Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. J Palliat Med. 2022 Jan;25(1):60-69. doi: 10.1089/jpm.2021.0081. Epub 2021 Aug 12.

  PMID: 34388037 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph G Winger, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: November 17, 2017
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)