Mindfulness Based Couples Therapy

NCT02349217 | Completed

• 2 other identifiers: 2014-0233NCI-2015-00507
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.

Conditions

Breast Cancer

Keywords

Breast cancer; Breast cancer survivors; Breast cancer partners; Mindfulness-Based Relationship Enhancement; MBRE; Standard of care; Pain Assessment; Questionnaires; Surveys; Neurocognitive Tests; Cortisol Tests; Saliva tests; Interviews; Meditation; Yoga; Self-help materials

Outcome Measures

Primary Outcomes (1)

• Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions)

  Feasibility endpoint is intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions.

  12 weeks

Study Arms (2)

Mindfulness Based Stress Reduction Intervention (MBRE)

EXPERIMENTAL

Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Behavioral: Mindfulness-Based Relationship Enhancement (MBRE); Behavioral: Pain Assessment; Behavioral: Questionnaires; Behavioral: Neurocognitive Tests; Procedure: Cortisol Tests; Behavioral: Interviews

Standard of Care

ACTIVE COMPARATOR

Participants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Behavioral: Self-Help Materials; Behavioral: Pain Assessment; Behavioral: Questionnaires; Behavioral: Neurocognitive Tests; Procedure: Cortisol Tests; Behavioral: Interviews

Interventions

Mindfulness-Based Relationship Enhancement (MBRE) BEHAVIORAL

Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.

Mindfulness Based Stress Reduction Intervention (MBRE)

Self-Help Materials BEHAVIORAL

Participants and partner receive self-help materials.

Standard of Care

Pain Assessment BEHAVIORAL

Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.

Mindfulness Based Stress Reduction Intervention (MBRE); Standard of Care

Questionnaires BEHAVIORAL

Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.

Also known as: Surveys

Mindfulness Based Stress Reduction Intervention (MBRE); Standard of Care

Neurocognitive Tests BEHAVIORAL

Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.

Mindfulness Based Stress Reduction Intervention (MBRE); Standard of Care

Cortisol Tests PROCEDURE

Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.

Also known as: Saliva tests

Mindfulness Based Stress Reduction Intervention (MBRE); Standard of Care

Interviews BEHAVIORAL

Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.

Mindfulness Based Stress Reduction Intervention (MBRE); Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 0-IIIA breast cancer survivors and their partner
• All the female breast cancer survivors will be at least two months from receiving cancer treatment (surgery, adjuvant therapy or radiation) and within three years from completing cancer treatment, except for tamoxifen/aromatase inhibitors.
• Are able to read and write in English
• Are able to pass the Physical Activity Readiness Questionnaire or participant provides a letter from their physician or nurse practitioner clearing them for study participation
• All couples co-habiting for at least 3 years with current partner who is willing to participate in study
• Are 21 years of age or older

You may not qualify if:

• Male breast cancer survivors;
• Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
• Anti-inflammatory medications (e.g. statins, cholesterol medication)
• Consume excessive amounts of alcohol (\>30 drinks/week)
• Pregnant or thinking about becoming pregnant during the study period
• Lactating women
• Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
• Pressure readings \>/=140/90 mm Hg, as defined by the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be deemed ineligible to participate and excluded from the study. They will be referred to their family physician or community services. Those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study.
• A hemoglobin level \< 10g/dl
• Person less than 21 years of age

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires; Mental Status and Dementia Tests; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Robert Dantzer, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 28, 2015
• Study Start: January 23, 2015
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

US (2)