Health TrialsbyHealthPanel

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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: Phase 1: Couple-Based Mindfulness Disclosure GroupExperimental treatment 2 interventions
Group B: Phase 2: Couple-Based Mindfulness Disclosure GroupExperimental treatment 2 interventions
Group C: Phase 3: Couple-Based Mindfulness Disclosure GroupExperimental treatment 2 interventions
Group D: Phase 3: Cancer-Related Discussion Program GroupExperimental treatment 2 interventions
Group E: Phase 3: Attention Control (AC) GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 months
2

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.

Time frame
4 months
3

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.

Time frame
4 months
4

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.

Time frame
4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

American Cancer Society, Inc.

Collaborator

Source ClinicalTrials.gov
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