Clinical trial NCT06198010: A Collaborative Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors (ASCENT)
Official title: Achieving Equity Through Socioculturally-Informed, Digitally-Enabled Cancer Pain Management (ASCENT) - Main Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Hematopoietic and Lymphatic System Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-10
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. 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. Digitally facilitated solutions are especially well matched for these patients, and can be customized to address their needs. The ASCENT intervention provides patients with an educational guide that describes techniques for addressing cancer pain, and uses community health workers and pain care managers to coach patients through a personalized pain management plan. This study may help researchers learn how pain management strategies can improve cancer pain and lower risk of opioid exposure and dependency in rural and Hispanic cancer survivors.

Detailed description: NOTE: Although Mayo Clinic in Arizona, Mayo Clinic in Florida, and Mayo Clinic in Rochester are the main study locations, this study is also recruiting (enrolling remotely) at the following Mayo Clinic Health System locations. The study is virtual/remote, so no travel is required.

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.

Eligibility 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 reasonse

Primary outcomes:
measure: Change in Pain Score
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Physical function
timeFrame: Baseline, 3 months, 6 months
measure: Perceived Quality of Life
timeFrame: Baseline, 3 months, 6 months
measure: Depression
timeFrame: Baseline, 3 months, 6 months
measure: Anxiety
timeFrame: Baseline, 3 months, 6 months
measure: Sleep
timeFrame: Baseline, 3 months, 6 months
measure: Employment status
timeFrame: Baseline, 3 months, 6 months
measure: Adherence to behavioral multimodal pain care plan components
timeFrame: Baseline, 3 months, 6 months
measure: Use of study electronic-tools
timeFrame: Baseline, 3 months, 6 months
measure: Social isolation
timeFrame: Baseline, 3 months, 6 months
measure: Opioid consumption
timeFrame: Up to 6 months
measure: Health care utilization
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
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: