Online Psychosocial Intervention in Improving Social Well-Being and Support in Women with Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Have access to the internet
- Able to read, write and speak English
- Major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- Regular (self-defined) participation in psychotherapy or a formal cancer support group
I. Examine the feasibility (primary outcome) of the BREATHE intervention in women with lung cancer (LC).
I. Establish the initial intervention efficacy regarding psychological distress (secondary outcome) and cancer symptoms (tertiary outcome) relative to an education comparison (EC) group.
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 Phase Phase NA
Trial Type Supportive care
M D Anderson Cancer Center
- Primary ID 2018-0501
- Secondary IDs NCI-2018-02113
- Clinicaltrials.gov ID NCT03731585