Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Enhanced Usual Care; Behavioral: Pathways

• Registration Number: NCT06047301
• Lead Sponsor: Laurie McLouth

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-11-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer
• 18 years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100
• 3-12 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Usual Care	Enhanced Usual Care	Enhanced 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).
Pathways	Pathways	Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.

Primary Outcome Measures

Name	Time	Method
Change in PROMIS Depression Short Form Scores	12 weeks (Baseline, Post-Intervention)	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.
Change in State Hope scores	12 weeks (Baseline, Post-Intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores	12 weeks (Baseline, Post-Intervention)	Meaning/Peace is measured using the FACIT-Spiritual Well-being Meaning/Peace Subscale. 8 items are responded to on a scale of 0 = not at all to 4 = very much. Raw scores range from 0-32. Higher scores indicate more meaning/peace.
Change in PROMIS 15a positive affect scores	12 weeks (Baseline, Post-Intervention)	Positive affect is measured using the PROMIS 15a positive affect form. Higher scores indicate more positive affect. Items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 15 to 45. Higher scores indicate more positive affect.
Change in FACT-G7 Quality of Life Scores	12 weeks (Baseline, Post-Intervention)	Quality of Life is measured using the FACT-G7. 7 items are responded to on a scale of 0 = not at all to 4 = very much to assess physical, emotional, and functional wellbeing. Raw scores range from 0 to 28. Higher scores indicate better quality of life.
Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores	12 weeks (Baseline, Post-Intervention)	Satisfaction with Social Activities and Roles is measured using the ROMIS Satisfaction with Participation in Social Roles 8a Short Form. 8 items are responded to on a scale of 1 = not at all to 5 = very much. Raw scores range from 8 to 40. Higher scores indicate better function.
Change in PROMIS Anxiety Short Form Scores	12 weeks (Baseline, Post-Intervention)	Anxiety symptoms are measured using the PROMIS Anxiety Short Form 4a. 4 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 4 to 20. Higher scores indicate more anxiety.
Change in Demoralization Scale II Scores	12 weeks (Baseline, Post-Intervention)	Demoralization symptoms are measured using the Demoralization Scale II: 16 items are responded to on a scale of 0 = never to 2 = always; Raw scores range from 0-32. Higher scores indicate more demoralization.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States