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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02596490
• Other study ID #: 2015-0275
• Secondary ID: 1R21CA191711NCI-
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2016
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Kathrin Milbury, PHD, MA
• Phone: 713-745-2868
• Email: KMilbury[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Questionnaires
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
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
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.

Locations

Country	Name	City	State
United States	Memorial Hermann	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Cancer Society, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center