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

Not Applicable

Active, not recruiting

• Conditions: Stage IIB Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
• Interventions: Behavioral: Behavioral Intervention; Other: Educational Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy

• Registration Number: NCT03731585
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Study Start: 2018-11-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (educational intervention)	Support Group Therapy	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.
Group I (psychological intervention)	Questionnaire Administration	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 I (psychological intervention)	Support Group Therapy	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 I (psychological intervention)	Behavioral Intervention	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 intervention)	Educational Intervention	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.
Group II (educational intervention)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
BREATHE intervention in women with Lung Cancer determined successful by acceptability	Up to 3 months	Acceptability assessed by ≥ 75% of participants indicating that the program is useful and enjoyable in each arm.
BREATHE intervention in women with Lung Cancer determined successful by overall accrual	Up to 3 months	Overall accrual assessed by ≥ 50% of eligible patients consent (i.e., approach 140 to achieve 70 that consent).
BREATHE intervention in women with Lung Cancer determined successful by attrition	Up to 3 months	Attrition assessed by ≥ 71% of enrolled patients (≥ 50 patients) complete T1 and T2 assessments;
BREATHE intervention in women with Lung Cancer determined successful by adherence	Up to 3 months	Adherence assessed by ≥ 75% of all practice sessions are attended in each arm.

Secondary Outcome Measures

Name	Time	Method
Efficacy regarding psychological distress: CES-D	Up to 3 months	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).
Efficacy regarding cancer symptoms: IES	Up to 3 months	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States