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NCT Number: NCT03207360

Pain Coping Skills and Meaning-Centered Intervention

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).

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Key information

Conditions

Advanced Cancer Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Meaning-Centered Psychotherapy

Primary outcomes

  1. Feasibility as measured by study accrual

    Time frame: 5 weeks (immediately post-intervention)

    Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm trial) in the 24-month study period.

  2. Feasibility as measured by study attrition

    Time frame: 5 weeks (immediately post-intervention)

    Treatment feasibility will be shown by no more than 30% study attrition. Attrition will be defined as not completing the post-intervention assessment.

  3. Acceptability as measured by the Client Satisfaction Questionnaire eight-item version (CSQ)

    Time frame: 5 weeks (immediately post-intervention)

    Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol (mean score of 7) on the CSQ.

  4. Acceptability as measured by engagement

    Time frame: 3 weeks, 4 weeks, and 5 weeks (sessions 2, 3, and 4)

    Acceptability will be indicated by reported practice of the skills and ideas from the intervention in at least 75% of the sessions.

  5. Change in pain and pain interference

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

    Pain and pain interference will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF).

  6. Change in meaning in life

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

    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).

Secondary outcomes

  1. Change in self-efficacy for pain management

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

    Self-efficacy for pain management will be measured using the five-item self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.

  2. Change in anxiety

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

    Anxiety will be measured using the seven-item version of the Generalized Anxiety Disorders scale (GAD-7).

  3. Change in depressive symptoms

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

    Depressive symptoms will be measured using the eight-item version of the Patient Health Questionnaire (PHQ-8).

  4. Change in hopelessness

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

    Hopelessness will be measured using the eight-item Hopelessness Assessment in Illness Questionnaire.

  5. Change in fatigue

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

    Fatigue will be assessed using the four-item Fatigue Symptom Inventory (FSI).

  6. Change in health-related quality of life

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

    Health-related quality of life will be assessed using the 16-item version of the McGill Quality of Life Questionnaire.

  7. Change in performance status

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

    Performance status will be assessed using the one-item self-report version of the Karnofsky Performance Rating Scale.

  8. Change in meaningfulness in life despite pain

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

    Meaningfulness in life despite pain will be measured using the five-item Pain Solutions Questionnaire - Meaningfulness in Life Despite Pain subscale.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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