Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
April 15, 2026
April 1, 2026
8.9 years
October 12, 2018
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Efficacy regarding psychological distress: CES-D
Up to 3 months
Efficacy regarding cancer symptoms: IES
Up to 3 months
Study Arms (2)
Group I (psychological intervention)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients 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.
Interventions
Participate in psychological sessions
Participate in educational sessions
Ancillary studies
Participate in group sessions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 34663123DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrin Milbury
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2018
First Posted
November 6, 2018
Study Start
November 15, 2018
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04