Clinical trial NCT03207360: Pain Coping Skills and Meaning-Centered Intervention
Official title: Pain Coping Skills Training and Meaning-Centered Intervention for Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility as measured by study accrual
timeFrame: 5 weeks (immediately post-intervention)
measure: Feasibility as measured by study attrition
timeFrame: 5 weeks (immediately post-intervention)
measure: Acceptability as measured by the Client Satisfaction Questionnaire eight-item version (CSQ)
timeFrame: 5 weeks (immediately post-intervention)
measure: Acceptability as measured by engagement
timeFrame: 3 weeks, 4 weeks, and 5 weeks (sessions 2, 3, and 4)
measure: Change in pain and pain interference
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in meaning in life
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
Secondary outcomes:
measure: Change in self-efficacy for pain management
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in anxiety
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in depressive symptoms
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in hopelessness
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in fatigue
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in health-related quality of life
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in performance status
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
measure: Change in meaningfulness in life despite pain
timeFrame: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph G Winger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.