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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03731585
• Other study ID #: 2018-0501
• Secondary ID: NCI-2018-0211320
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Behavioral:
• Behavioral Intervention
Participate in psychological sessions

Other:
• Educational Intervention
Participate in educational sessions
• Questionnaire Administration
Ancillary studies

Procedure:
• Support Group Therapy
Participate in group sessions

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

•   MD Anderson Cancer Center Website