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Mindfulness Meditation vs. Survivorship Education for Breast Cancer Survivors (PTW Trial)
N/A
Waitlist Available
Led By Patricia Ganz
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-intervention to 6 months
Awards & highlights
PTW Trial Summary
This trial will compare mindfulness meditation and survivorship education to see which is more effective in improving behavioral symptoms in younger stage 0-III breast cancer survivors.
Who is the study for?
This trial is for women under 50, diagnosed with early-stage breast cancer (Stage 0-III) within the past 5 years, who have finished initial treatments at least 6 months ago but may still be on certain therapies. They should not be actively practicing mindfulness and must commit to a schedule of weekly group meetings. Participants need to show mild depression symptoms and cannot have recurrent or metastatic cancer.Check my eligibility
What is being tested?
The study compares two approaches: mindfulness meditation and survivorship education, aiming to improve behavioral symptoms in young breast cancer survivors. It's testing if these interventions can reduce stress and enhance quality of life by changing reactions to triggers.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like meditation therapy and educational programs, traditional side effects associated with medications are not expected. However, participants might experience emotional discomfort or increased awareness of stressful thoughts during the process.
PTW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-intervention to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-intervention to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
Secondary outcome measures
Change in fatigue assessed by Fatigue Symptom Inventory
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
+3 morePTW Trial Design
3Treatment groups
Active Control
Group I: Arm A (MAPs)Active Control3 Interventions
Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
Group II: Arm B (SE)Active Control3 Interventions
Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
Group III: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)Active Control4 Interventions
Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
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25,979 Total Patients Enrolled
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National Institutes of Health (NIH)NIH
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National Cancer Institute (NCI)NIH
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You finished surgery, radiation, or chemotherapy at least 6 months ago, but you may still be taking trastuzumab or hormone therapy.Currently practicing mindfulness meditation.Women under 50 years old who were diagnosed with early stage breast cancer within the last 5 years.You have had breast cancer come back or spread to other parts of the body, or have been diagnosed with another cancer after having breast cancer.You have a serious medical or mental health condition that would make it difficult for you to take part in the study or to measure the results accurately.You have shown signs of feeling sad or down when answering a set of questions.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (MAPs)
- Group 2: Arm B (SE)
- Group 3: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment actively seeking volunteers?
"This particular medical study is no longer accepting participants, as indicated by the information displayed on clinicaltrials.gov; it was initially posted in February 2017 and last updated in July 2022. However, there are more than two thousand three hundred thirty seven separate trials currently enrolling patients at this time."
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