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

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.

Conditions

• Chronic Leukemia
• Hematopoietic and Lymphoid System Neoplasm
• Lymphoma
• Malignant Solid Neoplasm
• Multiple Myeloma

Interventions

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Andrea L. Cheville, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-22

Primary Completion

2024-02-02

Completion

2024-05-02

Countries

• United States

Study Locations