Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: Cancer-Related Discussion Program; Behavioral: Meditation and Discussion Sessions; Behavioral: Questionnaires

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02596490

2015-0275

NCI-2015-02128 (Registry Identifier)

1R21CA191711 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Objectives:

Our specific aims are to:

Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners.

Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ALL PHASES, PATIENTS ONLY: Diagnosed with stage IV Non-Small Cell Lung Cancer (NSCLC)
2. ALL PHASES, PATIENTS ONLY: Currently receiving treatment (e.g. radiotherapy, chemotherapy) at MD Anderson Cancer Center
3. ALL PHASES, PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
4. ALL PHASES, PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months
5. ALL PHASES, PATIENTS AND PARTNERS: Must be at least 18 years old
6. ALL PHASES, PATIENTS AND PARTNERS: Able to read and speak English
7. ALL PHASES, PATIENTS AND PARTNERS: Able to provide consent.

Exclusion criteria

1. ALL PHASES, PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team
2. ALL PHASES, PATIENTS AND PARTNERS: Regular (self-defined) participation in psychotherapy or a formal cancer support group
3. ALL PHASES, PATIENTS AND PARTNERS: Prior enrollment in a couple-based mind-body intervention research study (protocols 2011-1179, 2013-0496, 2014-0036) conducted by the principal investigator including phase 1 or phase 2 of the current study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 5 patient groups

Phase 1: Couple-Based Mindfulness Disclosure Group

Experimental group

Description:

Phase 1: Couples participate in 2 guided meditation sessions. During the sessions, participants do deep breathing and visualization exercises then asked to review the exercises. Participants also asked for feedback about the instructions. Participants complete a written review about the program and a questionnaire about their general health and well-being. Each session will last about 60-90 minutes.

Treatment:

Behavioral: Questionnaires

Behavioral: Meditation and Discussion Sessions

Phase 2: Couple-Based Mindfulness Disclosure Group

Experimental group

Description:

Phase 2: Participants complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. After completing the last session, about 4 weeks later, participants complete the same questionnaires again. Participants also complete a program review. Couples participate in 4 guided meditation sessions with a trained meditation instructor. Participants do deep breathing and visualization exercises. All meditation and discussion sessions videotaped. Participants continue daily meditation practice and some other short exercises at home.

Treatment:

Behavioral: Questionnaires

Behavioral: Meditation and Discussion Sessions

Phase 3: Couple-Based Mindfulness Disclosure Group

Experimental group

Description:

Participant completes 13 questionnaires before first mediation session, after last session, and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. Participant and partner attend meditation class with a trained meditation instructor each week for 4 weeks. Each session will last about 60 minutes total. Meditation and discussion sessions videotaped.

Treatment:

Behavioral: Questionnaires

Behavioral: Meditation and Discussion Sessions

Phase 3: Cancer-Related Discussion Program Group

Experimental group

Description:

Participant completes 13 questionnaires before first mediation session, after last session, and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. Participant and partner take part in a discussion program, 1 discussion session each week for 4 weeks with a trained interventionist. These are one-on-one sessions. Issues discussed for couples coping with cancer. Each session will last about 60 minutes.

Treatment:

Behavioral: Questionnaires

Behavioral: Cancer-Related Discussion Program

Phase 3: Attention Control (AC) Group

Other group

Description:

Participant completes 13 questionnaires at baseline and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires.

Treatment:

Behavioral: Questionnaires