Mindfulness for Breast Cancer

Mindfulness Training to Improve Well-being in Post-Treatment Breast Cancer Patients

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 Overview

• Status: Completed
• Conditions: Depression; Breast Cancer; Anxiety
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mindfulness Based Cognitive Therapy (MBCT); 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.	Behavioral: Mindfulness Based Cognitive Therapy; Weekly MBCT sessions consist of: a) mindfulness practice including breath-focused sitting meditation, body scanning, and mindful stretching; b) review of previous weeks' homework and an overview of the current week's homework; c) barriers to completing the homework. Homework includes: a) practicing the mindfulness exercise reviewed in class using the CDs provided to each participant (guided practice of the relevant exercise); b) maintaining a calendar of pleasant events; c) mindfully engaging in activities of daily living; and d) logging practice efforts in a daily log.
Active Comparator: Treatment as Usual (TAU); 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).	Behavioral: Treatment as Usual; Subjects randomized to the Treatment as Usual group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Level using the State-Trait Anxiety Inventory (STAI)-Form Y	This measure consists of 20-items that assess trait anxiety and 20 for state anxiety.	3 Months
Change in level of Depression using the Beck Depression Inventory-II (BDI-II)	The 21-item version of this widely used measure will be used to assess depressive symptoms.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)	PROMISE: 10 Item measure of quality of life	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):	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.	3 Months
Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)		3 Months
Change in Rumination using the Ruminative Responses Scale (RSS):	Change in the level of escalating cycles of negative thinking	3 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tanya Spruill, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: depression; anxiety; Mindfulness Based Cognitive Therapy (MBCT)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Depression; Breast Neoplasms
• Other Study ID Numbers: 14-01138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No