Pain Coping Skills and Meaning-Centered Intervention



Status:Enrolling by invitation
Conditions:Cancer, Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:November 17, 2017
End Date:June 2020

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

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).

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.

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)
- 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)
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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