Meaning-Centered Pain Coping Skills Training for Cancer Pain (MCPC)

Duke University

Status: Enrolling

Conditions: Advanced Solid Tumor; Pain

Treatments: Behavioral: Meaning-Centered Pain Coping Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05385965

Pro00110762

Details and patient eligibility

About

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).

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Meaning-Centered Pain Coping Skills Training

Experimental group

Description:

Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery, activity pacing) for managing pain.

Treatment:

Behavioral: Meaning-Centered Pain Coping Skills Training

Standard Care

No Intervention group

Description:

Information and referrals for free services available through the Duke Cancer Patient Support Program.