Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)
This study is looking at whether a program called Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) can help women with breast cancer manage stress after their main treatments are finished. R-CBSM is a group stress management program delivered online, using video calls like Zoom, to teach relaxation, coping skills, and cognitive behavioral therapy techniques. You might be able to join if you are a woman aged 50 or older, have completed primary treatment for Stage I-III HR+ (estrogen/progesterone positive) and Her2neu- (Human Epidermal Growth Factor Receptor 2 negative) breast cancer 3-12 months ago, are post-menopausal, and have elevated distress. The study will measure changes in your psychological adaptation (how well you cope with stress) and immune cell function over 24 months. This study aims to enroll 192 participants.
- Study design
- This is an interventional study comparing the R-CBSM program to standard survivorship care planning. It plans to enroll 192 participants.
- What's involved
- Participants will receive either 10 weeks of structured group sessions for R-CBSM or a 30-minute orientation call for standard care. Measurements will be taken at the start, 6 months, 12 months, and 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in psychological adaptation and immune cell function for up to 24 months after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael Antoni, Ph.D · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)Baseline, 6 months, 12 months
Cancer-specific intrusive distress will be measured using the 7-item Intrusion subscale of the Impact of Event Scale (IES). Each item is scored 0 ("not at all"), 1 ("rarely"), 3 ("sometimes"), or 5 ("often"), yielding a total score range of 0-35. Scores reflect the frequency of intrusive, cancer-related thoughts over the past 7 days. Higher scores indicate greater intrusive distress, and lower scores indicate fewer intrusive thoughts and better psychological adaptation. Change scores will be calculated as slope of change over 3 time points (baseline, 6months, and 12 months). Negative slops indicate improvement (reduced intrusive distress), and positive values indicate worsening. Change scores (slopes) will be compared between the R-CBSM+SCP and SCP-only arms to evaluate whether the combined intervention produces greater improvement over 6 and 12 months.
- Change in Immune Cell Senescence measured by Lymphocyte Metabolic FunctionBaseline, 6 months, 12 months, 24 months
Change in immune cell senescence will be measured using latent construct composite of B- and T-lymphocyte metabolic indicators (ATP production, maximum respiration, and spare respiratory capacity). A composite score will be created from ATP production, maximum respiration, and spare respiratory capacity to index lymphocyte hyper-metabolism, a marker of cancer-accelerated aging. Higher composite values indicate greater immune senescence. Composite change scores (slope of change over the 4 time points) will be compared between study arms, R-CBSM+SCP and SCP only, over 6- and 12-months Increases indicate worsening immune senescence while decrease indicate lessening immune senescence.