A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors (ASCENT)

Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT)

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Other: Best Practice; Other: Educational Intervention; Procedure: Health Telemonitoring; Behavioral: Cancer Pain Management

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josiah Lulf; Phone Number: 507-538-7991; Email: Lulf.Josiah@mayo.edu
• Study Contact Backup: Name: Clinical Trials Referral Office; Phone Number: 507-293-1043; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Jessica D. Austin, Ph.D.
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Gerardo Colon-Otero, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Andrea L. Cheville, M.D.
      • Contact: Josiah Lulf; Phone Number: 507-538-7991; Email: Lulf.Josiah@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 response

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (enhanced usual care); 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: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Best Practice; Receive enhanced usual care; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive ASCENT guide; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Experimental: Arm II (ASCENT intervention); 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: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Best Practice; Receive enhanced usual care; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive ASCENT guide; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: Health Telemonitoring; Attend video or phone calls with a CHW and/or PCM; Behavioral: Cancer Pain Management; Receive personalized pain management plan; Other Names: management of cancer pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Employment status	Employment status will be self-reported	Baseline, 3 months, 6 months
Adherence to behavioral multimodal pain care plan components	Will be measured using logged count data.	Baseline, 3 months, 6 months
Use of study electronic-tools	Will be measured in minutes/week that participants access available electronic tools.	Baseline, 3 months, 6 months
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
Opioid consumption	Will be measured in oral morphine equivalents and collected using electronic health record (EHR) prescriptions.	Up to 6 months
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrea L. Cheville, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Quality of Health Care; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Methods; Standard of Care; Early Intervention, Educational; Educational Status; Practice Guidelines as Topic
• Other Study ID Numbers: ASCENT_MAIN; R33CA278594 (U.S. NIH Grant/Contract); 23-010838 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No