Advanced Solid Tumor, Pain
Conditions
Keywords
Caner pain management, Psychosocial intervention, Spiritual aspects of coping with pain, Pain Coping Skills Training, Meaning-Centered Psychotherapy
Brief summary
This study is a randomized controlled trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and pain interference will be randomized to MCPC or a standard care control condition. Patient-reported outcomes will be assessed at baseline and 8- and 12-week follow-ups. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
Detailed description
Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with activities they care about. Psychosocial interventions show promise for improving cancer-related pain; however, there is a lack of interventions that address existential and spiritual concerns (e.g., a loss of meaning, purpose, and peace) that are common among those facing high levels of pain interference from advanced cancer. To address this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was developed. In this trial, the investigators will randomize patients to MCPC or enhanced usual care control (target N = 210). Patient-reported outcomes will be assessed at baseline and 8- and 12-weeks after baseline. As in the investigators' extensive pilot work, MCPC's four 45-to-60 minute individual weekly sessions will be delivered by trained study therapists via an accessible videoconference format. Intervention sessions focus on training participants in evidence-based cognitive-behavioral skills, such as guided imagery and activity pacing. Emphasis is placed on using skills to reduce the degree to which pain interferes with participants' sense of meaning, purpose, and peace. The first aim of this trial is to determine the efficacy of MCPC for reducing the primary outcome of pain interference at 8-weeks. The second aim is to determine the efficacy of MCPC for improving secondary outcomes at 8-weeks. The third aim is to test the maintenance of MCPC's effects on primary and secondary outcomes at 12-weeks. The fourth aim is to estimate the cost-effectiveness of implementing MCPC.
Interventions
The goal of this intervention is to help participants reduce pain interference so that they can engage with what gives them a sense of meaning, purpose, and peace.
Sponsors
Duke University
American Cancer Society, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomly assigned with equal allocation to an intervention or a standard care control condition, using a stratified block randomization scheme to ensure group balance based on patient performance status (i.e., Eastern Cooperative Oncology Group \[ECOG\] score of 0 vs. 1 or 2) and pain interference (i.e., Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference 8-item raw score of 25 or lower vs. 26 or higher) at screening.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage IV solid tumor cancer diagnosis * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower * At least one clinical pain severity rating \> 0 out of 10 in past month * At least moderate pain interference (8-item Patient-Reported Outcomes Measurement Information System \[PROMIS\] Pain Interference T-score \>/= 55) in the past week at telephone screening * Ability to speak and read in English * Age \>/= 18 years.
Exclusion criteria
* Significant cognitive impairment as indicated in medical chart or during telephone screening * Serious untreated mental illness * Primary brain cancer diagnosis * Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy * Enrollment in hospice at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form | 8-week follow-up | This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-item 5-level EuroQol Group (EQ-5D-5L) | 8-week follow-up and 12-week follow-up | This 5-item measure assesses health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The response options range from 1 to 5, with response choices that vary per question. Higher scores indicate worse health-related quality of life. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form | 12-week follow-up | This 8-item measure assesses the degree to which, over the past 7 days, pain has interfered with daily activities, work around the home, engagement in social activities, household chores, fun activities, enjoyment of social activities, enjoyment of life, and family life. Response options range from 1 (not at all) to 5 (very much). Higher scores indicate worse pain interference. |
| Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Subscale | 8-week follow-up and 12-week follow-up | This 4-item measure assesses pain severity at its worst, least, and average over the past 7 days as well as current pain severity. Response options range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate worse pain severity. |
| Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) | 8-week follow-up and 12-week follow-up | This 12-item measure references the past 7 days and includes an overall spiritual well-being score and three subscales: 1) meaning (i.e., reason for living, sense of meaning and purpose); 2) peace (i.e., feeling peaceful, sense of harmony within oneself); and 3) faith (i.e., finding strength and comfort in faith or spiritual beliefs). Response options range from 0 (not at all) to 4 (very much); two items are reverse coded. Higher scores indicate greater spiritual well-being. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale | 8-week follow-up and 12-week follow-up | This 8-item measure assesses feelings of meaning and purpose, including having a good sense of what makes one's life meaningful, a sense that one's life is valuable and worthwhile, having clear goals and aims, feeling life one's life has meaning, significance, direction, fulfillment, and purpose. Response options range from 1 (strongly disagree or not at all) to 5 (strongly agree or very much). Higher scores indicate greater meaning and purpose. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form | 8-week follow-up and 12-week follow-up | This 8-item measure assesses anxiety symptoms over the past 7 days, including fear, difficulty focusing on things other than anxiety, feeling overwhelmed by worries, feeling uneasy, nervousness, feeling the need for help with anxiety, feeling anxious, and feeling tense. Response options range from 1 (never) to 5 (always). Higher scores indicate worse anxiety. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form | 8-week follow-up and 12-week follow-up | This 8-item measure assesses depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, hopelessness, depression, failure, unhappiness, nothing to look forward to, and difficulty improving mood. Response options range from 1 (never) to 5 (always). Higher scores indicate worse depressive symptoms. |
| Medical Outcomes Study Social Support Survey (MOS-SS) | 8-week follow-up and 12-week follow-up | This 8-item measure assesses how often someone was available to provide instrumental (i.e., practical) support and emotional support. Instrumental support includes having someone available if confided to bed, needing to visit a doctor, needing help preparing meals, and needing help with daily chores. Emotional support includes having someone available to have a good time with, turn to for suggestions, feel understood, and feel loved and wanted. Response options range from 1 (none of the time) to 5 (all of the time). Higher scores indicate greater social support. |
| Chronic Pain Self-Efficacy Scale (CPS) | 8-week follow-up and 12-week follow-up | This 5-item measures assesses 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. Response options range from 10 (not at all certain) to 100 (very certain). Higher scores indicate greater self-efficacy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph G Winger, PhD
Duke University
Outcome results
None listed