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

M.D. Anderson Cancer Center

Status: Active, not recruiting

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

Treatments: Other: Educational Intervention; Behavioral: Behavioral Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03731585

2018-0501 (Other Identifier)

NCI-2018-02113 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group I (psychological intervention)

Experimental group

Description:

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.

Treatment:

Procedure: Support Group Therapy

Other: Questionnaire Administration

Behavioral: Behavioral Intervention

Group II (educational intervention)

Experimental group

Description:

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.

Treatment:

Procedure: Support Group Therapy

Other: Questionnaire Administration

Other: Educational Intervention