A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors

NCT06198010 | Recruiting DMC

• 3 other identifiers: ASCENT_MAINR33CA27859423-010838
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in 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. All cancer survivors stand to benefit from electronic health record innovations, as they can experience profound pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially helpful and can be customized to address patient 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 cancer survivors.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Physical function

  Baseline, 3 months, 6 months

• Perceived Quality of Life

  Baseline, 3 months, 6 months

• Depression

  Baseline, 3 months, 6 months

• Anxiety

  Baseline, 3 months, 6 months

• Sleep

  Baseline, 3 months, 6 months

Study Arms (2)

Arm I (enhanced usual care)

ACTIVE COMPARATOR

Patients receive enhanced usual care, which includes access to the educational and pain self-management materials developed for the ASCENT trial (the ASCENT guide).

Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Electronic Health Record Review

Arm II (ASCENT intervention)

EXPERIMENTAL

Patients receive the ASCENT guide and attend 3 video or phone calls over 30 minutes each with their CHW and/or 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.

Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration; Other: Electronic Health Record Review; Procedure: Health Telemonitoring; Behavioral: Cancer Pain Management

Interventions

Best Practice OTHER

Receive enhanced usual care

Also known as: standard of care, standard therapy

Arm I (enhanced usual care); Arm II (ASCENT intervention)

Educational Intervention OTHER

Receive ASCENT guide

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (enhanced usual care); Arm II (ASCENT intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm I (enhanced usual care); Arm II (ASCENT intervention)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (enhanced usual care); Arm II (ASCENT intervention)

Health Telemonitoring PROCEDURE

Attend video or phone calls with a CHW and/or PCM

Arm II (ASCENT intervention)

Cancer Pain Management BEHAVIORAL

Receive personalized pain management plan

Also known as: management of cancer pain

Arm II (ASCENT intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 response

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Andrea L. Cheville, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

507-293-1043; mayocliniccancerstudies@mayo.edu

Josiah Lulf

CONTACT

507-538-7991; Lulf.Josiah@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient Reported Outcome Measures will be administered at baseline by a study coordinator and at 3 and 6 months by a blinded, bilingual, assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (3)