RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain Management (ASCENT) Clinical Trial - Main

Quick Facts

Study Start:2024-02-07
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06198010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site in the past 15 years
  2. * Including malignant hematology
  3. * Lymphoma
  4. * Myeloma
  5. * Chronic leukemias
  6. * Age \>= 18
  7. * Numeric Rating Scale (NRS) pain score of \>= 5/10
  8. * Pain that developed or worsened following cancer diagnosis
  9. * Fit the description of either rural or Hispanic or both
  1. * Patient Health Questionnaire - 8 (PHQ8) score of \>= 13
  2. * Hospice enrollment
  3. * Skilled nursing facility, inpatient rehabilitation facility, or long-term care placement
  4. * Encounters with Palliative Care or the Pain Clinic in the past two months or upcoming two months
  5. * Any mention of hospice referral in medical oncology encounter notes (assess through textual search of the Mayo Data Explorer)
  6. * Affirmative response to, "Are you usually confined to a bed or chair more than a third of your waking hours because of your health?"
  7. * Currently homeless
  8. * Do not feel safe in their home
  9. * New or worsening chest pain, chest tightness, or chest pressure
  10. * Back pain that is associated with a new or worsening weakness, control of bowels/bladder, or difficulty walking
  11. * Lightheadedness, inability to keep down food or fluids, or vomiting blood or dark coffee-grounds-like material
  12. * New or worsening headaches that are associated with vision changes, nausea, balance issues, or problems with speech
  13. * Screens positive for use of non-cannabis drug use a a frequency of monthly or greater
  14. * Inability to engage with the intervention due to medical or psychological response

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
507-293-1043
mayocliniccancerstudies@mayo.edu
Josiah Lulf
CONTACT
507-538-7991
Lulf.Josiah@mayo.edu

Principal Investigator

Andrea L. Cheville, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Andrea L. Cheville, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-02-07
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

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