NCT03731585

Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment

Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Participate in psychological sessions
OTHER	Educational Intervention	Participate in educational sessions
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Support Group Therapy	Participate in group sessions

Timeline

• Start date: 2018-11-15
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2018-11-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States