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Meditation for Lung Cancer
N/A
Recruiting
Led By Kathrin Milbury, PHD, MA
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the feasibility and efficacy of a couple-based meditation program for patients with metastatic lung cancer and their partners.
Who is the study for?
This trial is for patients over 18 with stage IV Non-Small Cell Lung Cancer (NSCLC) who are being treated at MD Anderson Cancer Center and have an ECOG status of ≤2. They must live with a romantic partner for at least 6 months. Both patient and partner should speak English, be able to consent, and not participate in regular psychotherapy or cancer support groups.
What is being tested?
The study tests the feasibility of a couple-based meditation program aimed at improving quality of life for metastatic lung cancer patients and their partners. It involves questionnaires, meditation sessions, and discussions about cancer-related topics to assess physical, psychological, and spiritual outcomes.
What are the potential side effects?
Since this trial focuses on meditation rather than medication or invasive procedures, side effects may include emotional discomfort or distress related to discussing sensitive topics during sessions but are generally expected to be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Feasibility of Couple-Based Meditation for Participants with Lung Cancer and Their Partners
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase 3: Couple-Based Mindfulness Disclosure GroupExperimental Treatment2 Interventions
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.
Group II: Phase 3: Cancer-Related Discussion Program GroupExperimental Treatment2 Interventions
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.
Group III: Phase 3: Attention Control (AC) GroupExperimental Treatment1 Intervention
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.
Group IV: Phase 2: Couple-Based Mindfulness Disclosure GroupExperimental Treatment2 Interventions
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.
Group V: Phase 1: Couple-Based Mindfulness Disclosure GroupExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~4280
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,738 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,346 Total Patients Enrolled
American Cancer Society, Inc.OTHER
231 Previous Clinical Trials
109,411 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients must have lived with their romantic partner for at least 6 months to be eligible for the study.You regularly participate in therapy or a support group to help you cope with cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: Couple-Based Mindfulness Disclosure Group
- Group 2: Phase 3: Attention Control (AC) Group
- Group 3: Phase 3: Cancer-Related Discussion Program Group
- Group 4: Phase 3: Couple-Based Mindfulness Disclosure Group
- Group 5: Phase 1: Couple-Based Mindfulness Disclosure Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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