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

August 28, 2025 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site
  • Age 18+
  • Numerical rating scale (NRS) pain score of a 5+ out of 10
  • Pain that developed (onset) or significantly worsened since cancer diagnosis

  • Malignant hematology including:

    • Lymphoma
    • Myeloma
    • Chronic leukemias

Exclusion Criteria:

  • Patient Health Questionnaire (PHQ) 8 score of 10 or more
  • Life expectancy less than 12 months
  • Hospice enrollment
  • Admitted to hospital from long term care/skilled nursing facilities (SNF)
  • Acute leukemias
  • Primary brain tumors
  • Confinement to a bed or a chair more than a third of waking hours because of health complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (Pain management)
See detailed description.
Procedure: Acupuncture Therapy
Undergo acupuncture therapy
Other Names:
  • Acupuncture
Other: Survey Administration
Ancillary studies
Other: Interview
Complete interview
Behavioral: Cognitive Behavior Therapy
Undergo CBT
Other Names:
  • CT
  • CBT
  • cognitive therapy
Behavioral: Cancer Pain Management
Receive pain clinic referral
Other Names:
  • management of cancer pain
Other: Educational Intervention
Receive self-guided pain management education materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Exercise
Participate in exercise
Other Names:
  • Exercise Type
Procedure: Massage Therapy
Receive massage
Other Names:
  • Massage
Behavioral: Mindfulness Relaxation
Practice mindfulness
Other Names:
  • MBSR
  • Mindfulness-Based Stress Reduction
  • Mindfulness Meditation
  • Mindful Meditation
Procedure: Pain Therapy
Receive pain treatment/medicine
Other Names:
  • Analgesia
  • Pain Control
  • Pain Management
  • Pain, Pain Management
Other: Palliative Therapy
Receive palliative care referral
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Behavioral: Patient Navigation
Undergo visits with PCM and CHW for pain management
Other Names:
  • Patient Navigator Program
Other: Referral
Receive pain management referrals
Other Names:
  • Referred
Procedure: Spiritual Therapy
Receive spiritual support
Procedure: Spiritual Care Referral
Receive spiritual care referral
Active Comparator: Group II (Interview)
ASCENT study interventionists complete an interview on study.
Other: Interview
Complete interview
Active Comparator: Group III (Focus group)
Medical oncology providers participate in a focus group on study.
Procedure: Discussion
Participate in focus group
Other Names:
  • Discuss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention - Interaction
Time Frame: Up to 60 days
As assessed by frequency of participant interaction with care team.
Up to 60 days
Acceptability of Intervention - Satisfaction
Time Frame: Up to 60 days
As assessed by participant satisfaction with care team interactions
Up to 60 days
Utility of Intervention - Helpfulness
Time Frame: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
Up to 60 days
Utility of Intervention - Confidence
Time Frame: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.
Up to 60 days
Utility of Intervention - Ease
Time Frame: Up to 60 days
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
Up to 60 days
Feasibility of Intervention
Time Frame: Up to 60 days
Assessed by proportion of participants who received key intervention components.
Up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andrea L. Cheville, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCENT_Pilot
  • ASCENT (Other Identifier: Mayo Clinic in Rochester)
  • NCI-2023-05223 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 23-004139 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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