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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Meditation and Discussion Sessions
Cancer-Related Discussion Program
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Couples-based meditation program, Couples-based cancer-related discussion program, Questionnaires, Surveys, Metastatic lung cancer, Quality of life, QOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Texas MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Phase 1: Couple-Based Mindfulness Disclosure Group

Phase 2: Couple-Based Mindfulness Disclosure Group

Phase 3: Couple-Based Mindfulness Disclosure Group

Phase 3: Cancer-Related Discussion Program Group

Phase 3: Attention Control (AC) Group

Arm 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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
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
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
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
Intervention deemed feasible if no attributable adverse events (AE) or serious adverse events (SAE) occur.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2015
Last Updated
August 15, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02596490
Brief Title
Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners
Official Title
Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, Couples-based meditation program, Couples-based cancer-related discussion program, Questionnaires, Surveys, Metastatic lung cancer, Quality of life, QOL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Couple-Based Mindfulness Disclosure Group
Arm Type
Experimental
Arm 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.
Arm Title
Phase 2: Couple-Based Mindfulness Disclosure Group
Arm Type
Experimental
Arm 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.
Arm Title
Phase 3: Couple-Based Mindfulness Disclosure Group
Arm Type
Experimental
Arm 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.
Arm Title
Phase 3: Cancer-Related Discussion Program Group
Arm Type
Experimental
Arm 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.
Arm Title
Phase 3: Attention Control (AC) Group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation and Discussion Sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cancer-Related Discussion Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Description
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.
Time Frame
4 months
Title
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Description
Intervention deemed feasible if >60% of enrolled couples complete Time 1 and Time 2 survey assessments.
Time Frame
4 months
Title
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Description
Intervention deemed feasible if on average >50% of all practice sessions are attended.
Time Frame
4 months
Title
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Description
Intervention deemed feasible if no attributable adverse events (AE) or serious adverse events (SAE) occur.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Milbury, PHD, MA
Phone
713-745-2868
Email
KMilbury@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathrin Milbury, PHD, MA
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
29416870
Citation
Milbury K, Tsao AS, Liao Z, Owns A, Engle R, Gonzalez EA, Bruera E, Cohen L. A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners. Pilot Feasibility Stud. 2018 Jan 24;4:37. doi: 10.1186/s40814-018-0231-6. eCollection 2018.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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