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Spots Global Cancer Trial Database for Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

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Trial Identification

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

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

Study ID: NCT06063603

Study Description

Brief 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. OUTLINE: Participants are assigned to 1 of 3 groups. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Contact Details

Name: Andrea L. Cheville, M.D.

Affiliation: Mayo Clinic in Rochester

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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