Meaning-Centered Pain Coping Skills Training

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431830
• Other study ID #: Pro00105953
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 3, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by study accrual	Treatment feasibility will be evidenced by meeting study accrual (N = 60).	Baseline
Primary	Feasibility as measured by adherence and assessment completion	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.	5-week follow-up (immediately post-intervention)
Primary	Feasibility as measured by attrition	Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.	5-week follow-up (immediately post-intervention)
Secondary	Change in pain severity	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in pain interference	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in meaning in life	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in self-efficacy for pain management	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in anxiety	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in depressive symptoms	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
Secondary	Change in hopelessness	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.	Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up