A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06198010
- Status
- Recruiting
Conditions
- Hematopoietic and Lymphatic System Neoplasm
- Hematopoietic and Lymphoid System Neoplasm
- Malignant Solid Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Best Practice — OTHERReceive enhanced usual care
- Educational Intervention — OTHERReceive ASCENT guide
- Questionnaire Administration — OTHERAncillary studies
- Electronic Health Record Review — OTHERAncillary studies
- Health Telemonitoring — PROCEDUREAttend video or phone calls with a CHW and/or PCM
- Cancer Pain Management — BEHAVIORALReceive personalized pain management plan
Study Details
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. All cancer survivors stand to benefit from electronic health record innovations, as they can experience profound pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially helpful and can be customized to address patient needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in cancer survivors.
Key Dates
- Start date
- Feb 7, 2024
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 660 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Arm I (enhanced usual care)Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
- Experimental: Arm II (ASCENT intervention)Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or PCM. During the first call, patients discuss barriers to receiving help for their pain with their CHW. During the second call, patients work with their PCM to develop an action plan for addressing their pain using the different techniques and interventions detailed in the ASCENT guide. During the third and final call, patients meet with both their CHW and PCM to discuss specialist recommendations for their pain management plan. After the final visit, patients will be contacted by the CHW or PCM every other week to monitor their progress and may also be contacted as-needed based on the their reported pain intensity, symptoms, or reported barriers.
Primary Outcome Measure
Change in Pain Score [ Time Frame: Baseline, 3 months, 6 months ]
Central Contacts
- Clinical Trials Referral Office507-293-1043
- Josiah Lulf507-538-7991
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Jessica D. Austin, Ph.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Gerardo Colon-Otero, M.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Andrea L. Cheville, M.D. (PRINCIPAL_INVESTIGATOR) |
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