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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02596490

Collaborator

National Cancer Institute (NCI) (NIH), American Cancer Society, Inc. (Other)

200

Enrollment

Location

Arms

104

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Behavioral: Questionnaires Behavioral: Meditation and Discussion Sessions Behavioral: Cancer-Related Discussion Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1: Couple-Based Mindfulness Disclosure Group 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.	Behavioral: Questionnaires Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participant complete 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. AC group completes same questionnaires with no intervention. Other Names: Surveys Behavioral: Meditation and Discussion Sessions Phase 1: Participant and partner attend 2 meditation sessions with a mediation trained instructor. Each session will last about 60-90 minutes. Phase 2 and 3: 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.
Experimental: Phase 2: Couple-Based Mindfulness Disclosure Group 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.	Behavioral: Questionnaires Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participant complete 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. AC group completes same questionnaires with no intervention. Other Names: Surveys Behavioral: Meditation and Discussion Sessions Phase 1: Participant and partner attend 2 meditation sessions with a mediation trained instructor. Each session will last about 60-90 minutes. Phase 2 and 3: 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.
Experimental: Phase 3: Couple-Based Mindfulness Disclosure Group 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.	Behavioral: Questionnaires Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participant complete 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. AC group completes same questionnaires with no intervention. Other Names: Surveys Behavioral: Meditation and Discussion Sessions Phase 1: Participant and partner attend 2 meditation sessions with a mediation trained instructor. Each session will last about 60-90 minutes. Phase 2 and 3: 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.
Experimental: Phase 3: Cancer-Related Discussion Program Group 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.	Behavioral: Questionnaires Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participant complete 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. AC group completes same questionnaires with no intervention. Other Names: Surveys Behavioral: Cancer-Related Discussion Program Phase 3: Participant and partner attend 1 discussion session each week for 4 weeks with a trained interventionist. During the discussion sessions, participants discuss issues for couples coping with cancer. Each session will last about 60 minutes.
Other: Phase 3: Attention Control (AC) Group 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.	Behavioral: Questionnaires Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being. Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions. Phase 3: Participant complete 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. AC group completes same questionnaires with no intervention. Other Names: Surveys

Outcome Measures

Primary Outcome Measures

Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [4 months]
Efficacy based on physical, psychological, and spiritual quality of life outcomes. T-tests used to compare the pre-post change in the quality of life (QOL) outcomes between interventions separately for the participants and caregivers.
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [4 months]
Intervention deemed feasible if >60% of enrolled couples complete Time 1 and Time 2 survey assessments.
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [4 months]
Intervention deemed feasible if on average >50% of all practice sessions are attended.
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners [4 months]
Intervention deemed feasible if no attributable adverse events (AE) or serious adverse events (SAE) occur.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

ALL PHASES, PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team
ALL PHASES, PATIENTS AND PARTNERS: Regular (self-defined) participation in psychotherapy or a formal cancer support group
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.