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Online Support and Education for Lung Cancer
N/A
Waitlist Available
Led By Kathrin Milbury
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
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Women diagnosed with stage I-IV non-small cell lung cancer within 3 months of diagnosis at the time of recruitment and receiving any type of treatment at the time of recruitment. For women with metastatic disease, disease must be stable (without disease progression based on patients' latest imaging impressions) per treating oncologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial is testing whether an online psychosocial intervention can improve social well-being and support for women with non-small cell lung cancer.
Who is the study for?
This trial is for women with stage I-IV non-small cell lung cancer diagnosed within the last 3 months, currently undergoing treatment. Participants must have stable disease if metastatic, be able to perform daily activities (ECOG <=2), have internet access, and can read and speak English. Women already in psychotherapy or support groups or those with major psychiatric issues are excluded.Check my eligibility
What is being tested?
The study tests an online psychosocial intervention aimed at improving social well-being and support for women during lung cancer treatment. It includes mindfulness, compassion training, emotional processing exercises, educational materials, and questionnaires to track progress.See study design
What are the potential side effects?
Since this is a psychological/educational intervention rather than a drug trial, traditional physical side effects are not expected. However, participants may experience emotional discomfort when discussing personal experiences or feelings during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am a woman diagnosed with lung cancer recently and my disease is stable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BREATHE intervention in women with Lung Cancer determined successful by acceptability
BREATHE intervention in women with Lung Cancer determined successful by adherence
BREATHE intervention in women with Lung Cancer determined successful by attrition
+1 moreSecondary outcome measures
Efficacy regarding cancer symptoms: IES
Efficacy regarding psychological distress: CES-D
Side effects data
From 2013 Phase 1 & 2 trial • 16 Patients • NCT0192389613%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Behavioral Intervention & DCS
Behavioral Intervention & Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group II (educational intervention)Experimental Treatment3 Interventions
Patients participate in 5 information sessions and receive education on lung cancer, symptom management, communication, and practicing self-care once a week for up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in group I.
Group II: Group I (psychological intervention)Experimental Treatment3 Interventions
Patients participate in 5 psychological sessions and complete training on mindfulness, compassion, emotional processing, social support, generating positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients also complete questionnaires over 35 minutes and participate in video-based group sessions weekly for 5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Support Group Therapy
2021
N/A
~80
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,711 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,083 Total Patients Enrolled
Kathrin MilburyPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
1,881 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I regularly attend psychotherapy or a cancer support group.I am a woman diagnosed with lung cancer recently and my disease is stable.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (psychological intervention)
- Group 2: Group II (educational intervention)
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.
Are there any slots available for participants in this research project?
"According to records on clinicaltrials.gov, this medical trial has stopped recruitment proceedings for the time being. It was initially posted in November 2018 and last amended in June 2022; however, there are still 2048 other studies seeking volunteers across the globe."
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