Improving cancer pain management for rural and Hispanic survivors
Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT)
This study is testing a new way to help rural and Hispanic cancer survivors manage their pain better by giving them extra support and education on pain management techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06198010 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests a collaborative intervention called ASCENT aimed at enhancing pain management for rural and Hispanic cancer survivors. The approach involves providing patients with an educational guide on pain management techniques and personalized coaching through community health workers and pain care managers. Participants are randomized into two groups: one receiving standard care and the other receiving additional support through video or phone calls. The goal is to improve pain control while addressing social determinants of health that affect access to care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a qualifying cancer diagnosis, experiencing significant pain, and identifying as rural or Hispanic.
Not a fit: Patients currently enrolled in hospice care or those with severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management and quality of life for rural and Hispanic cancer survivors.
How similar studies have performed: Other studies have shown promise in using collaborative care models for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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?"
* 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 response
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Andrea L. Cheville, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 507-293-1043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.