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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment

Conditions
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Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 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, Stage IA3 Lung Cancer AJCC v8, Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Educational Intervention
* Other: Questionnaire Administration
* Procedure: Support Group Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (psychological intervention)<br>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. | Behavioral: Behavioral Intervention<br>* Participate in psychological sessions<br>* Other names: Behavioral Treatments;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Support Group Therapy<br>* Participate in group sessions<br>|
| Experimental: Group II (educational intervention)<br>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. | Other: Educational Intervention<br>* Participate in educational sessions<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Support Group Therapy<br>* Participate in group sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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; | 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. | 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. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Up to 3 months |