Mindfulness for Breast Cancer

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02647216

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Breast Cancer	Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Treatment as Usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Tanya Spruill, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02647216

Other Study ID Numbers:

14-01138

First Posted:

Jan 6, 2016

Last Update Posted:

May 18, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

Mindfulness Based Cognitive Therapy (MBCT)

anxiety

depression

Additional relevant MeSH terms:

Breast Neoplasms

Depression

Study Results

No Results Posted as of May 18, 2020