RECRUITING

Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors

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

The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires. Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).

Official Title

Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors

Quick Facts

Study Start:2024-12-06
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06728579

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * English-proficient women with a history of stage I, II, or III breast cancer
  3. * Free of oncologic disease by clinical examination and history;
  4. * Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months;
  5. * Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
  6. * Reporting at least 15 days with pain in the preceding 30 days prior to consent;
  7. * Experiencing joint pain for at least one month;
  8. * Pain attributed to AI therapy;
  9. * Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: Mindfulness-Oriented Recovery Enhancement (MORE) or Supportive Group Psychotherapy (SG);
  10. * Able to attend video-call sessions in a quiet/private location.
  1. * Metastatic breast cancer (stage IV);
  2. * Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
  3. * Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
  4. * Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
  5. * Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.

Contacts and Locations

Study Contact

Jun Mao, MD, MSCE
CONTACT
646-608-8553
maoj@mskcc.org
Karolina Bryl, PhD
CONTACT
646-608-8573
brylk@mskcc.org

Principal Investigator

Jun Mao, MD, MSCE
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

University of California San Diego (Data collection and Data analysis)
San Diego, California, 92103
United States
Florida State University
Tallahassee, Florida, 32306
United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jun Mao, MD, MSCE, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2024-12-06
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Enhanced Pain Coping in Cancer
  • Mindfulness Oriented Recovery Enhancement
  • Aromatase inhibitors
  • Arthralgia
  • Ache
  • Cancer Pain
  • Cancer Survivors

Additional Relevant MeSH Terms

  • Breast Cancer Survivor