Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment
Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
2 other identifiers
interventional
234
1 country
1
Brief Summary
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Nov 2023
Typical duration for not_applicable lung-cancer
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
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
November 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
May 8, 2026
May 1, 2026
4.3 years
September 14, 2023
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in PROMIS Depression Short Form Scores
Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30. Higher scores indicate more depression.
12 weeks (Baseline, Post-Intervention)
Change in State Hope scores
Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.
12 weeks (Baseline, Post-Intervention)
Secondary Outcomes (6)
Change in PROMIS Anxiety Short Form Scores
12 weeks (Baseline, Post-Intervention)
Change in Demoralization Scale II Scores
12 weeks (Baseline, Post-Intervention)
Change in PROMIS 15a positive affect scores
12 weeks (Baseline, Post-Intervention)
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
12 weeks (Baseline, Post-Intervention)
Change in FACT-G7 Quality of Life Scores
12 weeks (Baseline, Post-Intervention)
- +1 more secondary outcomes
Study Arms (2)
Pathways
EXPERIMENTALPathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
Enhanced Usual Care
ACTIVE COMPARATOREnhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).
Interventions
Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.
Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.
Eligibility Criteria
You may qualify if:
- New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer
- years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100
- weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
- Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items.
You may not qualify if:
- Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses)
- Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
- Receiving overlapping palliative care or psychological services at the cancer center
- Unable to speak and read English.
- Hearing or visual impairment that precludes study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laurie McLouthlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurie McLouth, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 14, 2023
First Posted
September 21, 2023
Study Start
November 29, 2023
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be submitted to ICPSR a year after study completion. ICPSR will archive the full dataset and its documentation for the long term.
- Access Criteria
- ICPSR will make the data available to the broader research community. Files for public use (direct and indirect identifiers removed) will be accessible directly through the ICPSR website. After agreeing to Terms of Use, users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.
Data Description: The proposed research will include clinical and patient-reported outcome data from approximately 234 participants with advanced stage lung cancer. Patients will complete surveys prior to randomization, mid-intervention period, post-intervention, and at follow-ups. In addition to these survey data, disease and medical treatment information will be abstracted from the electronic health record, including cancer treatments received, performance status, hospitalizations, and death. Data Archive: Data from this study will be submitted to ICPSR (Inter-university Consortium for Political and Social Research), which will make de-identified data available as described under "access criteria."