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Brief Title: Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
Official Title: Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment
Study ID: NCT03731585
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Kathrin Milbury
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR