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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06198010
Other study ID # ASCENT_MAIN
Secondary ID R33CA27859423-01
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2024
Est. completion date August 31, 2027

Study information

Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date August 31, 2027
Est. primary completion date January 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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?" - Primary brain tumors - Acute leukemias - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practice
Receive enhanced usual care
Educational Intervention
Receive ASCENT guide
Questionnaire Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Procedure:
Health Telemonitoring
Attend video or phone calls with a CHW and/or PCM
Behavioral:
Cancer Pain Management
Receive personalized pain management plan

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain Score Will be measured using the Brief Pain Inventory Short Form (BPI SF), a 4-item questionnaire answered on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates worse pain. Baseline, 3 months, 6 months
Secondary Physical function Will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF) 6b, a 6-item questionnaire that measures the effects of pain on physical functioning over the past 7 days. Questions are answered on a scale of 1-5, with higher scores indicating more pain interference. Baseline, 3 months, 6 months
Secondary Perceived Quality of Life Will be measured using the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) questionnaire, which measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each component has three response levels of severity: no problems, some problems, extreme problems. Baseline, 3 months, 6 months
Secondary Depression Will be measured using the Patient Health Questionnaire-2 (PHQ-2), a two-item questionnaire answered with responses from 0 (not al all) to 3 (nearly every day). A higher score indicates a higher level of depression. Baseline, 3 months, 6 months
Secondary Anxiety Will be measured using the Generalized Anxiety Disorder-2 (GAD-2) scale, a two-item questionnaire answered with a score of 0 (not at all) to 3 (nearly every day). A higher score indicates higher frequency of being bothered by anxiety. Baseline, 3 months, 6 months
Secondary Sleep Will be measured using the PROMIS Sleep Disturbance 6a, a 6-item questionnaire assessing sleep disturbance over the past 7 days. Each question is answered with a score of 1-5, with a higher score indicating greater sleep disturbance. Baseline, 3 months, 6 months
Secondary Employment status Employment status will be self-reported Baseline, 3 months, 6 months
Secondary Adherence to behavioral multimodal pain care plan components Will be measured using logged count data. Baseline, 3 months, 6 months
Secondary Use of study electronic-tools Will be measured in minutes/week that participants access available electronic tools. Baseline, 3 months, 6 months
Secondary Social isolation Will be measured using the PROMIS SF 4a, a six-item questionnaire with each question answered on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate greater perceived social isolation. Baseline, 3 months, 6 months
Secondary Opioid consumption Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions. Up to 6 months
Secondary Health care utilization Will be measured by reviewing the electronic health record (EHR) and administrative billing data for incidents of hospitalization and emergency department visits Up to 6 months
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