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Behavioural Intervention

Mindfulness-Based Cognitive Therapy for Breast Cancer

N/A
Waitlist Available
Led By Jacob Hill, ND
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

"This trial aims to create and test a program that can help improve mood and lessen depression symptoms."

Who is the study for?
This trial is for African American/Black women over 65 with mild to moderate depression and a history of Stage I, II or III breast cancer. They must speak English, have completed cancer treatment at least 3 months ago (except endocrine therapy), and be willing to consent to audio and video recording. Excluded are those with severe depression, recent changes in antidepressants, certain psychiatric conditions, daily meditation practice, or prior mindfulness training.Check my eligibility
What is being tested?
The study is testing an abbreviated form of Mindfulness-Based Cognitive Therapy (MBCT) designed to improve mood and reduce symptoms of depression in older African American/Black breast cancer survivors.See study design
What are the potential side effects?
While MBCT generally does not involve medication and thus has minimal physical side effects, participants may experience emotional discomfort as they confront difficult feelings during the mindfulness exercises.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean participant attendance rate
Secondary outcome measures
Acceptability rate using CSQ(Client Satisfaction Questionnaire-8)
Other outcome measures
Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores
Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores
Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mindfulness-Based Cognitive TherapyExperimental Treatment1 Intervention
MBCT-Brief includes 8 weekly 1-hour group sessions delivered either via telephone or video teleconferencing. The decision to deliver the intervention either via phone or teleconferencing will be made based on participant preference obtained during the formative focus groups. Telephone delivery of MBCT-Brief only requires a landline, while teleconferencing requires either a smartphone, tablet, or computer with audio and video functionality. During the MBCT-Brief intervention the instructor will lead in-session practice of medication and cognitive therapy exercises, guided inquiry, and assign and review at-home practice exercises. All sessions will be audio-recorded. Participants will be encouraged to practice daily meditation in between group sessions for 20 minutes, 6 days per week. Participants will complete practice logs to document daily meditation practice.

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
453 Previous Clinical Trials
31,859 Total Patients Enrolled
54 Trials studying Breast Cancer
4,936 Patients Enrolled for Breast Cancer
Jacob Hill, NDPrincipal InvestigatorCleveland Clinic Department of Wellness and Preventive Medicine, Cleveland Clinic, Case Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"As per clinicaltrials.gov, this investigation is presently not in the recruitment phase. The trial was initially listed on July 1st, 2024 and last revised on March 22nd, 2024. Despite this study being inactive for patient enrollment currently, there are a total of 4154 ongoing studies actively seeking participants."

Answered by AI
~21 spots leftby Jan 2025