This trial studies how well online psychosocial intervention works in improving social well-being and support in women who are undergoing treatment for stage I-IV non-small cell lung cancer. Psychosocial intervention techniques, such as mindfulness, compassion, and emotional processing, may improve distress and help patients manage symptoms related to non-small cell lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03731585.
Locations matching your search criteria
United States
Texas
Houston
UT MD Anderson Cancer CenterStatus: Temporarily closed to accrual
Contact: Kathrin Milbury
Phone: 713-745-2868
PRIMARY OBJECTIVES:
I. Examine the feasibility (primary outcome) of the BREATHE intervention in women with lung cancer (LC).
SECONDARY OBJECTIVES:
I. Establish the initial intervention efficacy regarding psychological distress (secondary outcome) and cancer symptoms (tertiary outcome) relative to an education comparison (EC) group.
EXPLORATORY OBJECTIVES:
I. Explore potential mediation (e.g., mindfulness, compassion, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (PSYCHOLOGICAL): 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.
GROUP II (EDUCATIONAL): 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.
After completion of study intervention, patients are followed up at 1 week and at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorKathrin Milbury