A Collaborative Pain Management Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors

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Mayo Clinic

Status

Enrolling

Conditions

Malignant Solid Neoplasm
Hematopoietic and Lymphoid System Neoplasm

Treatments

Other: Questionnaire Administration
Behavioral: Cancer Pain Management
Other: Educational Intervention
Procedure: Health Telemonitoring
Other: Best Practice
Other: Electronic Health Record Review

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06198010
ASCENT_MAIN
R33CA278594 (U.S. NIH Grant/Contract)
23-010838 (Other Identifier)

Details and patient eligibility

About

This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic 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. 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. Digitally facilitated solutions are especially well matched for these patients, and can be customized to address their 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 rural and Hispanic cancer survivors.

Full description

PRIMARY OBJECTIVE: I. To test a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic 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.

Enrollment

660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years

    • Including malignant hematology

      • Lymphoma
      • Myeloma
      • Chronic leukemias
  • Age >= 18

  • Numeric Rating Scale (NRS) pain score of >= 5/10

  • Pain that developed or worsened following cancer diagnosis

  • Fit the description of either rural or Hispanic or both

Exclusion criteria

  • Patient Health Questionnaire - 8 (PHQ8) score of >= 13
  • Hospice enrollment
  • Skilled nursing facility, inpatient rehabilitation facility, or long-term care placement
  • Encounters with Palliative Care or the Pain Clinic in the past two months or upcoming two months
  • Any mention of hospice referral in medical oncology encounter notes (assess through textual search of the Mayo Data Explorer)
  • Affirmative response to, "Are you usually confined to a bed or chair more than a third of your waking hours because of your health?"
  • Primary brain tumors
  • Acute leukemias
  • Currently homeless
  • Do not feel safe in their home
  • New or worsening chest pain, chest tightness, or chest pressure
  • Back pain that is associated with a new or worsening weakness, control of bowels/bladder, or difficulty walking
  • Lightheadedness, inability to keep down food or fluids, or vomiting blood or dark coffee-grounds-like material
  • New or worsening headaches that are associated with vision changes, nausea, balance issues, or problems with speech

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

660 participants in 2 patient groups

Arm I (enhanced usual care)
Active Comparator group
Description:
Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
Treatment:
Other: Electronic Health Record Review
Other: Best Practice
Other: Educational Intervention
Other: Questionnaire Administration
Arm II (ASCENT intervention)
Experimental group
Description:
Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or 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.
Treatment:
Other: Electronic Health Record Review
Procedure: Health Telemonitoring
Other: Best Practice
Other: Educational Intervention
Behavioral: Cancer Pain Management
Other: Questionnaire Administration

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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