Mindfulness for Breast Cancer

Not Applicable

Completed

• Conditions: Anxiety; Depression; Breast Cancer
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Treatment as Usual

• Registration Number: NCT02647216
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Primary Completion: 2019-02
• Study Completion: 2020-03-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Cognitive Therapy (MBCT)	Mindfulness Based Cognitive Therapy	MBCT is a structured 8-week group intervention which integrates aspects of cognitive behavioral therapy (CBT) with components of the Mindfulness Based Stress Reduction (MBSR) program.
Treatment as Usual (TAU)	Treatment as Usual	Subjects randomized to TAU will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study (for the TAU group) and outside of the study (for the MBCT group) will be assessed at the 3-month follow up (Visit 3).

Primary Outcome Measures

Name	Time	Method
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y	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)	3 Months	The 21-item version of this widely used measure will be used to assess depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
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 the level of escalating cycles of negative thinking
Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)	3 Months	PROMISE: 10 Item measure of quality of life
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	This 19-item measure assesses habitual sleep quality over the last month. It consists of 7 subscales (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction), and also provides a global sleep quality score.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States