Mindfulness for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647216
• Other study ID #: 14-01138
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Quality of Life using the Patient Reported Outcomes Measurement Information System (PROMISE)	PROMISE: 10 Item measure of quality of life	3 Months
Secondary	Change in fatigues score using a Functional Assessment of Cancer Therapy Breast and Fatigue subscales (FACIT-B and F):		3 Months
Secondary	Change in Physical Health Symptoms		3 Months
Secondary	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
Secondary	Change in Illness Perceptions using the Brief Illness Perception Questionnaire (B-IPQ)		3 Months
Secondary	Change in Rumination using the Ruminative Responses Scale (RSS):	Change in the level of escalating cycles of negative thinking	3 Months