A Collaborative Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors (ASCENT)
NCT ID: NCT06198010
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
660 participants
INTERVENTIONAL
2024-02-07
2027-08-31
Brief Summary
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Detailed Description
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Mayo Clinic Health Systems-Mankato Mankato, MN 56001, US
Mayo Clinic Health System in Albert Lea Albert Lea, MN 56007, US
Mayo Clinic Health System in Austin Austin, MN 55912, US
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, WI 54701, US
Mayo Clinic Health System-Franciscan Healthcare La Crosse, WI 54601, US
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (enhanced usual care)
Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).
Best Practice
Receive enhanced usual care
Educational Intervention
Receive ASCENT guide
Questionnaire Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Arm II (ASCENT intervention)
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.
Best Practice
Receive enhanced usual care
Educational Intervention
Receive ASCENT guide
Questionnaire Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Health Telemonitoring
Attend video or phone calls with a CHW and/or PCM
Cancer Pain Management
Receive personalized pain management plan
Interventions
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Best Practice
Receive enhanced usual care
Educational Intervention
Receive ASCENT guide
Questionnaire Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Health Telemonitoring
Attend video or phone calls with a CHW and/or PCM
Cancer Pain Management
Receive personalized pain management plan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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?"
* 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
* Screens positive for use of non-cannabis drug use a a frequency of monthly or greater
* Inability to engage with the intervention due to medical or psychological reasonse
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Andrea L. Cheville, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Josiah Lulf
Role: backup
Provided Documents
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Document Type: Study Protocol
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-010838
Identifier Type: OTHER
Identifier Source: secondary_id
ASCENT_MAIN
Identifier Type: -
Identifier Source: org_study_id