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

Not Applicable
Recruiting
Conditions
Lung Cancer
Registration Number
NCT02596490
Lead Sponsor
M.D. Anderson Cancer Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners4 months

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

Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners4 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Memorial Hermann

🇺🇸

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Memorial Hermann
🇺🇸Houston, Texas, United States

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