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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06063603
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
Mar 2024
Primary completion
Feb 2, 2024
Completion
May 2, 2024

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group I (Pain management)
    See detailed description.
  • Active Comparator: Group II (Interview)
    ASCENT study interventionists complete an interview on study.
  • Active Comparator: Group III (Focus group)
    Medical oncology providers participate in a focus group on study.

Primary Outcome Measure

Feasibility of Intervention [ Time Frame: Up to 60 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in RochesterRochesterMinnesota55905-

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