Clinical trial NCT06063603: Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Official title: Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Leukemia
Hematopoietic and Lymphoid System Neoplasm
Lymphoma
Malignant Solid Neoplasm
Multiple Myeloma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

OUTLINE: Participants are assigned to 1 of 3 groups.

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.

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

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Up to 60 days
measure: Acceptability of Intervention - Interaction
timeFrame: Up to 60 days
measure: Acceptability of Intervention - Satisfaction
timeFrame: Up to 60 days
measure: Utility of Intervention - Helpfulness
timeFrame: Up to 60 days
measure: Utility of Intervention - Confidence
timeFrame: Up to 60 days
measure: Utility of Intervention - Ease
timeFrame: Up to 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Andrea L. Cheville, M.D.
role: PRINCIPAL_INVESTIGATOR
References: