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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
ALL PHASES, PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will test the feasibility and efficacy of a couple-based meditation program for patients with metastatic lung cancer and their partners.
Eligible Conditions
- Lung Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Patients must have lived with their romantic partner for at least 6 months to be eligible for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
~3030
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,065 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,041 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,157 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 3: Couple-Based Mindfulness Disclosure Group
- Group 2: Phase 3: Cancer-Related Discussion Program Group
- Group 3: Phase 3: Attention Control (AC) Group
- Group 4: Phase 2: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in the research project presently attainable for individuals?
"Affirmative. Clinicaltrials.gov data displays that this research is currently open for enrolment, which was introduced on April 6th 2016 and last updated October 13th 2022. 200 individuals will be admitted from a single medical facility to partake in the study."
Answered by AI
What is the current estimated enrollment for this clinical trial?
"Right. The clinicaltrials.gov registry reveals that this medical experiment, first posted on April 6th 2016, is actively enrolling participants. This study seeks to recruit a total of 200 patients from one location."
Answered by AI
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