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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Participate in psychological sessions
Participate in educational sessions
Ancillary studies
Participate in group sessions
M D Anderson Cancer Center
Houston, Texas, United States
BREATHE intervention in women with Lung Cancer determined successful by overall accrual
Overall accrual assessed by ≥ 50% of eligible patients consent (i.e., approach 140 to achieve 70 that consent).
Time frame: Up to 3 months
BREATHE intervention in women with Lung Cancer determined successful by attrition
Attrition assessed by ≥ 71% of enrolled patients (≥ 50 patients) complete T1 and T2 assessments;
Time frame: Up to 3 months
BREATHE intervention in women with Lung Cancer determined successful by adherence
Adherence assessed by ≥ 75% of all practice sessions are attended in each arm.
Time frame: Up to 3 months
BREATHE intervention in women with Lung Cancer determined successful by acceptability
Acceptability assessed by ≥ 75% of participants indicating that the program is useful and enjoyable in each arm.
Time frame: Up to 3 months
Efficacy regarding psychological distress: CES-D
The study will examine preliminary evidence of intervention efficacy. Will calculate effect sizes for between-group comparisons based on the primary efficacy endpoint of Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item self-report measure focusing on the affective component of depression. Answers range from: almost never (less than 1 day), sometimes (1 to 2 days), often (3 to 4 days), almost always (5 to 7 days).
Time frame: Up to 3 months
Efficacy regarding cancer symptoms: IES
The study will examine preliminary evidence of intervention efficacy. Will calculate effect sizes for between-group comparisons based on the primary efficacy endpoint of Impact of Event Scale (IES) measured at T2 using analysis of covariance (ANCOVA). IES scale answers range from NOT AT ALL, RARELY, SOMETIMES, OFTEN.
Time frame: Up to 3 months
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