NCT06198010

A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors

Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

NOTE: Although Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic in Rochester are the main study locations, this study is also recruiting (enrolling remotely) at the following Mayo Clinic Health System locations. The study is virtual/remote, so no travel is required. Mayo Clinic Health Systems-Mankato Mankato, MN 56001, US Mayo Clinic Health System in Albert Lea Albert Lea, MN 56007, US Mayo Clinic Health System in Austin Austin, MN 55912, US Mayo Clinic Health System-Eau Claire Clinic Eau Claire, WI 54701, US Mayo Clinic Health System-Franciscan Healthcare La Crosse, WI 54601, US PRIMARY OBJECTIVE: I. To test a validated collaborative care model-based intervention aimed at improving pain control among cancer survivors by promoting multimodal pain care (MMPC) to reduce inappropriate opioid use and by addressing social determinants of health (SDOH) that impede a patient's access to appropriate care. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide). ARM II: Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their community health worker (CHW) and/or pain care manager (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.

Conditions

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Hematopoietic and Lymphatic System Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Receive enhanced usual care
OTHER	Educational Intervention	Receive ASCENT guide
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Electronic Health Record Review	Ancillary studies
PROCEDURE	Health Telemonitoring	Attend video or phone calls with a CHW and/or PCM
BEHAVIORAL	Cancer Pain Management	Receive personalized pain management plan

Timeline

• Start date: 2024-02-07
• Primary completion: 2027-01-31
• Completion: 2027-08-31
• First posted: 2024-01-10
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States