Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
Study Overview
Brief Summary
The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 and over
- •Able to speak and read English
- •Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years
Exclusion Criteria
- •Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
- •Major psychiatric disorder (e.g., psychosis, personality disorder)
- •Current suicidal ideation or suicide attempt within past 3 months
- •Past participation in an MBCT group
Outcomes
Primary Outcomes
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y
Time Frame: 3 Months
This measure consists of 20-items that assess trait anxiety and 20 for state anxiety.
Change in level of Depression using the Beck Depression Inventory-II (BDI-II)
Time Frame: 3 Months
The 21-item version of this widely used measure will be used to assess depressive symptoms.
Secondary Outcomes
- Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)(3 Months)
- Change in Rumination using the Ruminative Responses Scale (RSS):(3 Months)
- Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)(3 Months)
- Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):(3 Months)
- Change in Physical Health Symptoms(3 Months)
- Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):(3 Months)