Not currently recruiting at University of California Health

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

a study on Breast Cancer

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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.

Keywords

Breast Cancer Survivor, Enhanced Pain Coping in Cancer, Mindfulness Oriented Recovery Enhancement, Aromatase inhibitors, Arthralgia, Ache, Cancer Pain, Cancer Survivors, Breast Neoplasms, Mastodynia, Mindfulness Oriented Recovery Enhancement (MORE), Supportive Psychotherapy (SG)

Eligibility

You can join if…

Open to females ages 18 years and up

  • Age ≥18 years
  • English-proficient women with a history of stage I, II, or III breast cancer
  • Free of oncologic disease by clinical examination and history;
  • 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;
  • Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
  • Reporting at least 15 days with pain in the preceding 30 days prior to consent;
  • Experiencing joint pain for at least one month;
  • Pain attributed to AI therapy;
  • 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);
  • Able to attend video-call sessions in a quiet/private location.

You CAN'T join if...

  • Metastatic breast cancer (stage IV);
  • Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
  • Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
  • Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
  • Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.

Locations

  • University of California San Diego (Data collection and Data analysis) not yet accepting patients
    San Diego California 92103 United States
  • Florida State University not yet accepting patients
    Tallahassee Florida 32306 United States
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) accepting new patients
    Basking Ridge New Jersey 07920 United States
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) accepting new patients
    Middletown New Jersey 07748 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Memorial Sloan Kettering Cancer Center
Links
Memorial Sloan Kettering Cancer Center
ID
NCT06728579
Phase
Phase 2 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated