Clinical trial NCT05385965: Meaning-Centered Pain Coping Skills Training for Cancer Pain
Official title: Meaning-Centered Pain Coping Skills Training: A Randomized Controlled Trial of a Psychosocial Intervention for Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Solid Tumor
Pain
Keywords: Caner pain management
Psychosocial intervention
Spiritual aspects of coping with pain
Pain Coping Skills Training
Meaning-Centered Psychotherapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-05-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group \[ECOG\] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference (N=210) will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

Detailed description: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer.

To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize 210 patients to MCPC or enhanced usual care control. Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace.

The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.

Eligibility criteria: Inclusion Criteria:

* Stage IV solid tumor cancer diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
* At least one clinical pain severity rating \> 0 out of 10 in past month
* At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference T-score \>/= 55) in the past week at telephone screening
* Ability to speak and read in English
* Age \>/= 18 years.

Exclusion Criteria:

* Significant cognitive impairment as indicated in medical chart or during telephone screening
* Serious untreated mental illness
* Primary brain cancer diagnosis
* Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
* Enrollment in hospice at screening

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
timeFrame: 8-week follow-up
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form
timeFrame: 12-week follow-up
measure: Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale
timeFrame: 8-week follow-up and 12-week follow-up
measure: Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
timeFrame: 8-week follow-up and 12-week follow-up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale
timeFrame: 8-week follow-up and 12-week follow-up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form
timeFrame: 8-week follow-up and 12-week follow-up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form
timeFrame: 8-week follow-up and 12-week follow-up
measure: Chronic Pain Self-Efficacy Scale (CPS)
timeFrame: 8-week follow-up and 12-week follow-up
measure: Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: 8-week follow-up and 12-week follow-up
measure: 5-item 5-level EuroQol Group (EQ-5D-5L)
timeFrame: 8-week follow-up and 12-week follow-up
Other outcomes:
measure: All-cause medical resource use
timeFrame: Baseline, 8-week follow-up, and 12-week follow-up
measure: Participant time
timeFrame: 8-week follow-up
measure: Participant productivity
timeFrame: Baseline, 8-week follow-up, and 12-week follow-up
measure: Therapist time
timeFrame: 8-week follow-up
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph G Winger, PhD
role: PRINCIPAL_INVESTIGATOR
References: