Trials / Completed

CompletedNCT06063603

Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 51 (actual)

Sponsor: Mayo Clinic · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. 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. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.

Detailed description

PRIMARY OBJECTIVE: I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors. GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study. GROUP II: ASCENT study interventionists complete an interview on study. GROUP III: Medical oncology providers participate in a focus group on study.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Acupuncture Therapy	Undergo acupuncture therapy
BEHAVIORAL	Cancer Pain Management	Receive pain clinic referral
BEHAVIORAL	Cognitive Behavior Therapy	Undergo CBT
PROCEDURE	Discussion	Participate in focus group
OTHER	Educational Intervention	Receive self-guided pain management education materials
OTHER	Exercise	Participate in exercise
OTHER	Interview	Complete interview
PROCEDURE	Massage Therapy	Receive massage
BEHAVIORAL	Mindfulness Relaxation	Practice mindfulness
PROCEDURE	Pain Therapy	Receive pain treatment/medicine
OTHER	Palliative Therapy	Receive palliative care referral
BEHAVIORAL	Patient Navigation	Undergo visits with PCM and CHW for pain management
OTHER	Referral	Receive pain management referrals
PROCEDURE	Spiritual Therapy	Receive spiritual support
PROCEDURE	Spiritual Care Referral	Receive spiritual care referral
OTHER	Survey Administration	Ancillary studies

Timeline

Start date: 2023-05-22
Primary completion: 2024-02-02
Completion: 2024-05-02
First posted: 2023-10-02
Last updated: 2025-09-18
Results posted: 2025-09-18

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06063603. Inclusion in this directory is not an endorsement.