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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2027-09-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (psychological 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 Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in psychological sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Support Group Therapy

Intervention Type PROCEDURE

Participate in group sessions

Group II (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 Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in educational sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Support Group Therapy

Intervention Type PROCEDURE

Participate in group sessions

Interventions

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Behavioral Intervention

Participate in psychological sessions

Intervention Type BEHAVIORAL

Educational Intervention

Participate in educational sessions

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Support Group Therapy

Participate in group sessions

Intervention Type PROCEDURE

Other Intervention Names

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Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No