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Completed

NCT Number: NCT04431830

Meaning-Centered Pain Coping Skills Training

This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week follow-ups. The first aim of this study is to assess the feasibility of conducting a randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy for pain management, and psychological distress. The third aim is to describe participants' experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).

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Key information

Conditions

Advanced Solid Tumor 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, 27705, United States

About this study

Many patients with advanced cancer describe pain as their most feared and distressing symptom. In this population, higher pain levels often predict worse physical, emotional, and existential/spiritual well-being. Psychosocial interventions show promise for improving cancer-related pain; however, no interventions address existential concerns (e.g., a loss of meaning in life) that are common among those facing pain from advanced illness. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain (e.g., guided imagery) in order to help them engage with what gives their life a sense of meaning, purpose, and significance.

This pilot study is being conducted to prepare for a large-scale clinical trial that will test the efficacy of MCPC for improving patients' pain and pain-related outcomes.

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 (worst pain in past week >/= 4 out of 10) at screening
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening
  • Ability to speak and read English

Exclusion criteria

  • Brain tumor diagnosis
  • Significant cognitive impairment
  • Untreated serious mental illness that would interfere with engagement in the interventions (e.g., schizophrenia)
  • Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy
  • Enrollment in hospice

Treatment and study plan

Meaning-Centered Pain Coping Skills Training

Behavioral

The goal of this intervention is to help participants manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.

Primary outcomes

  1. Feasibility as measured by study accrual

    Time frame: Baseline

    Treatment feasibility will be evidenced by meeting study accrual (N = 60).

  2. Feasibility as measured by adherence and assessment completion

    Time frame: 5-week follow-up (immediately post-intervention)

    Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment.

  3. Feasibility as measured by attrition

    Time frame: 5-week follow-up (immediately post-intervention)

    Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.

Secondary outcomes

  1. Change in pain severity

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Pain severity will be measured using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain. The minimum value on this scale is 0 and the maximum value is 10. Higher scores represent worse outcomes.

  2. Change in pain interference

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Pain interference will be measured using the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form. This measure assesses the degree to which pain has impacted patients' enjoyment of life and engagement in social, cognitive, emotional, physical, and recreational activities. The minimum value on this scale is 6 and the maximum value is 30. Higher scores represent worse outcomes.

  3. Change in meaning in life

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    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).The minimum value on each subscale is 0 and the maximum value is 4. Higher scores represent better outcomes.

  4. Change in self-efficacy for pain management

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Self-efficacy for pain management will be measured using the Self-efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale. The subscale includes 5 items assessing patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication.The minimum value on this scale is 10 and the maximum value is 100. Higher scores represent better outcomes.

  5. Change in anxiety

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Anxiety will be measured using the 7-item version of the Generalized Anxiety Disorders scale (GAD-7), which assesses the frequency of nervousness, worry, difficulty relaxing, restlessness, irritability, and fear. The minimum value on this scale is 0 and the maximum value is 21. Higher scores represent worse outcomes.

  6. Change in depressive symptoms

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Depressive symptoms will be measured using the 8-item version of the Patient Health Questionnaire (PHQ-8), which assesses the frequency of anhedonia, depressed mood, sleep difficulties, lack of energy, appetite disturbance, low self-esteem, trouble concentrating, and psychomotor retardation.The minimum value on this scale is 0 and the maximum value is 24. Higher scores represent worse outcomes.

  7. Change in hopelessness

    Time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up

    Hopelessness will be measured using the Hopelessness Assessment in Illness Questionnaire. The scale includes 8 items assessing the degree to which patients have felt hopelessness, discouragement, and dread. The minimum value on this scale is 0 and the maximum value is 16. Higher scores represent worse outcomes.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
May 4, 2022

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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