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Meaning-Centered Pain Coping Skills Training

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ClinicalTrials.gov Identifier: NCT04431830
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Duke University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Pain Behavioral: Meaning-Centered Pain Coping Skills Training Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to an intervention or a standard care control condition.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Meaning-Centered Pain Coping Skills Training
Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain.
Behavioral: Meaning-Centered Pain Coping Skills Training
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.

No Intervention: Standard Care
Information and referrals for free services available through the Duke Cancer Patient Support Program.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431830


Contacts
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Contact: Joseph G Winger, PhD 919-416-7506 joseph.winger@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Joseph G Winger, PhD    919-416-7506    joseph.winger@duke.edu   
Sponsors and Collaborators
Duke University
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joseph G Winger, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04431830    
Other Study ID Numbers: Pro00105953
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Solid Tumor Cancer
Pain
Meaning-Centered Psychotherapy
Pain Coping Skills Training
Meaning-Centered Pain Coping
Advanced Cancer