A Collaborative Pain Management Intervention for Improving Cancer Pain Management in Rural and Hispanic Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

Achieving Equity Through Socioculturally-Informed, Digitally-Enabled Cancer Pain Management (ASCENT) - Main Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198010
• Other study ID #: ASCENT_MAIN
• Secondary ID: R33CA27859423-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cancer Pain
• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

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

External Links

•   Mayo Clinic Clinical Trials