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Completed

NCT Number: NCT02647216

Mindfulness for Breast Cancer

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).

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Cancer Breast Diseases Breast Neoplasms Depression Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  1. Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)

    Time frame: 3 Months

    PROMISE: 10 Item measure of quality of life

  2. Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):

    Time frame: 3 Months

  3. Change in Physical Health Symptoms

    Time frame: 3 Months

  4. Change in Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI):

    Time frame: 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.

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

    Time frame: 3 Months

  6. Change in Rumination using the Ruminative Responses Scale (RSS):

    Time frame: 3 Months

    Change in the level of escalating cycles of negative thinking

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jan 6, 2016
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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