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

Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; 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 IIIC Lung Cancer AJCC v8; Non-Small Cell Lung Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Procedure: Support Group Therapy; Other: Educational Intervention

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Behavioral Intervention; Participate in psychological sessions; Other Names: Behavior Conditioning Therapy; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Treatment; Behavioral Treatments; behavior modification; BEHAVIORAL THERAPY; Procedure: Support Group Therapy; Participate in group sessions
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Support Group Therapy; Participate in group sessions; Other: Educational Intervention; Participate in educational sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Milbury K, Kroll J, Chen A, Antonoff MB, Snyder S, Higgins H, Yang CC, Li Y, Bruera E. Pilot Randomized Controlled Trial in Women With Non-Small Cell Lung Cancer to Assess the Feasibility of Delivering Group-Based Psychosocial Care via Videoconference. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211052520. doi: 10.1177/15347354211052520.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2018-0501 (Other Identifier: M D Anderson Cancer Center); NCI-2018-02113 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No