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

Part of paid clinical trials in San Diego, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06728579
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Survivor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness Oriented Recovery Enhancement (MORE) — BEHAVIORAL
    eight weekly two-hour MORE sessions
  • Questionnaires — OTHER
    filled out up to 24 weeks
  • Supportive Psychotherapy (SG) — BEHAVIORAL
    eight weekly two-hour SG sessions

Study Details

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).

Key Dates

Start date
Dec 6, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MORE Treatment Group
    Participants randomized to the MORE arm will participate in eight weekly, two-hour group sessions following an established protocol. MORE sessions involve instruction in three therapeutic skills: 1) mindfulness to reduce pain and increase self regulation over maladaptive pain coping habits, (2) reappraisal to decrease psychological distress and negative affect, and 3) savoring to amplify natural reward processing and evoke positive emotion (see Figure 2). Participants will be asked to engage in 15 minutes per day of skill practice at home guided by audio recording, and to record the number of minutes they engaged in skill practice via a weekly Research Electronic Data Capture (REDCap) survey.
  • Active Comparator: Supportive Psychotherapy Control Group
    Participants randomized to SG will participate in eight weekly two-hour SG sessions led by the same instructors who deliver MORE interventions. The instructors will lead discussions on themes pertinent to chronic pain and cancer survivorship (see Figure 3) but will not teach MORE skills. To match the MORE homework requirement, SG participants will be asked to journal for 15 minutes/day on weekly session topics. Providers will employ empathic responding, elicit emotional expression, and promote a positive group climate.

Primary Outcome Measure

Pain Interference [ Time Frame: up to 24 weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San Diego (Data collection and Data analysis)San DiegoCalifornia92103
Eric Garland, PhD, LCSW
801-581-3826
Florida State UniversityTallahasseeFlorida32306
Adam Hanley, PhD
[email protected]
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)CommackNew York11725
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Jun Mao, MD, MSCE
646-888-0863

Find similar trials in San Diego, CA

By research site
University of California San Diego (Data collection and Data analysis)· San Diego, CAFlorida State University· Tallahassee, FLMemorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk- Commack (All Protocol Activities)· Commack, NY

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