N/A
N=59
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Chronic Leukemia · Hematopoietic and Lymphoid System Neoplasm · Lymphoma · Malignant Solid Neoplasm · Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT06063603 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Feasibility of Intervention — 41; 17; 11; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture Therapy (Procedure); Cancer Pain Management (Behavioral); Cognitive Behavior Therapy (Behavioral); Discussion (Procedure); Educational Intervention (Other); Exercise (Other); Interview (Other); Massage Therapy (Procedure); Mindfulness Relaxation (Behavioral); Pain Therapy (Procedure); Palliative Therapy (Other); Patient Navigation (Behavioral); Referral (Other); Spiritual Therapy (Procedure); Spiritual Care Referral (Procedure); Survey Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Intervention |
41; 17; 11; 5; 27; 16 | — |
| PRIMARY Acceptability of Intervention - Interaction |
0; 1; 18; 16; 0 | — |
| PRIMARY Acceptability of Intervention - Satisfaction |
0; 35 | — |
| PRIMARY Utility of Intervention - Helpfulness |
2; 7; 6; 9; 11; 0 | — |
| PRIMARY Utility of Intervention - Confidence |
2; 3; 6; 10; 9; 5 | — |
| PRIMARY Utility of Intervention - Ease |
0; 0; 0; 2; 15; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06063603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.