Mindfulness for Breast Cancer

NCT02647216 | Completed

• 1 other identifier: 14-01138
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Depression; Breast Cancer

Keywords

Mindfulness Based Cognitive Therapy (MBCT); anxiety; depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)

  3 Months

Study Arms (2)

Mindfulness Based Cognitive Therapy (MBCT)

ACTIVE COMPARATOR

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

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.

Mindfulness Based Cognitive Therapy (MBCT)

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Breast Neoplasms

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tanya Spruill

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Locations

US (1)