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NCT Number: NCT02596490

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

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.

Recruiting

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann, Houston, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaires

Behavioral

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

Meditation and Discussion Sessions

Behavioral

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.

Cancer-Related Discussion Program

Behavioral

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 outcomes

  1. Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners

    Time frame: 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.

  2. Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners

    Time frame: 4 months

    Intervention deemed feasible if >60% of enrolled couples complete Time 1 and Time 2 survey assessments.

  3. Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners

    Time frame: 4 months

    Intervention deemed feasible if on average >50% of all practice sessions are attended.

  4. Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners

    Time frame: 4 months

    Intervention deemed feasible if no attributable adverse events (AE) or serious adverse events (SAE) occur.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrin Milbury, PHD, MA

CONTACT

[email protected]

713-745-2868

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2015
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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