Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)
4 other identifiers
interventional
51
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2023
CompletedFirst Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2024
CompletedResults Posted
Study results publicly available
September 18, 2025
CompletedSeptember 18, 2025
March 1, 2024
9 months
September 13, 2023
June 30, 2025
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Feasibility of Intervention
Assessed by proportion of participants who received key intervention components.
Up to 60 days
Acceptability of Intervention - Interaction
As assessed by frequency of participant interaction with care team.
Up to 60 days
Acceptability of Intervention - Satisfaction
As assessed by participant satisfaction with care team interactions
Up to 60 days
Utility of Intervention - Helpfulness
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
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
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
Study Arms (3)
Group I (Pain management)
EXPERIMENTALSee detailed description.
Group II (Interview)
ACTIVE COMPARATORASCENT study interventionists complete an interview on study.
Group III (Focus group)
ACTIVE COMPARATORMedical oncology providers participate in a focus group on study.
Interventions
Undergo acupuncture therapy
Receive pain clinic referral
Undergo CBT
Receive self-guided pain management education materials
Practice mindfulness
Receive pain treatment/medicine
Receive palliative care referral
Undergo visits with PCM and CHW for pain management
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea L. Cheville, MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea L. Cheville, M.D.
Mayo Clinic in Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2023
First Posted
October 2, 2023
Study Start
May 22, 2023
Primary Completion
February 2, 2024
Study Completion
May 2, 2024
Last Updated
September 18, 2025
Results First Posted
September 18, 2025
Record last verified: 2024-03