NCT02596490

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
7mo left

Started Apr 2016

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Apr 2016Dec 2026

First Submitted

Initial submission to the registry

October 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 6, 2016

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

10.7 years

First QC Date

October 29, 2015

Last Update Submit

April 10, 2026

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung CancerNSCLCCouples-based meditation programCouples-based cancer-related discussion programQuestionnairesSurveysMetastatic lung cancerQuality of lifeQOL

Outcome Measures

Primary Outcomes (4)

  • 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.

    4 months

  • 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.

    4 months

  • 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.

    4 months

  • 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.

    4 months

Study Arms (5)

Phase 1: Couple-Based Mindfulness Disclosure Group

EXPERIMENTAL

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: QuestionnairesBehavioral: Meditation and Discussion Sessions

Phase 2: Couple-Based Mindfulness Disclosure Group

EXPERIMENTAL

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: QuestionnairesBehavioral: Meditation and Discussion Sessions

Phase 3: Couple-Based Mindfulness Disclosure Group

EXPERIMENTAL

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: QuestionnairesBehavioral: Meditation and Discussion Sessions

Phase 3: Cancer-Related Discussion Program Group

EXPERIMENTAL

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: QuestionnairesBehavioral: Cancer-Related Discussion Program

Phase 3: Attention Control (AC) Group

OTHER

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

Interventions

QuestionnairesBEHAVIORAL

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.

Also known as: Surveys
Phase 1: Couple-Based Mindfulness Disclosure GroupPhase 2: Couple-Based Mindfulness Disclosure GroupPhase 3: Attention Control (AC) GroupPhase 3: Cancer-Related Discussion Program GroupPhase 3: Couple-Based Mindfulness Disclosure Group
Meditation and Discussion SessionsBEHAVIORAL

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.

Phase 1: Couple-Based Mindfulness Disclosure GroupPhase 2: Couple-Based Mindfulness Disclosure GroupPhase 3: Couple-Based Mindfulness Disclosure Group
Cancer-Related Discussion ProgramBEHAVIORAL

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.

Phase 3: Cancer-Related Discussion Program Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29416870DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Surveys and QuestionnairesMeditation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kathrin Milbury, PHD, MA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Milbury, PHD, MA

CONTACT

713-745-2868KMilbury@mdanderson.org

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

October 29, 2015

First Posted

November 4, 2015

Study Start

April 6, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(2)