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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Pathways
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathways<br>Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer. | Behavioral: Pathways<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care<br>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). | Behavioral: Enhanced Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Anxiety Short Form Scores | 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. | 12 weeks (Baseline, Post-Intervention) | 
| Change in Demoralization Scale II Scores | 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. | 12 weeks (Baseline, Post-Intervention) | 
| Change in PROMIS 15a positive affect scores | 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. | 12 weeks (Baseline, Post-Intervention) | 
| Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores | 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. | 12 weeks (Baseline, Post-Intervention) | 
| Change in FACT-G7 Quality of Life Scores | 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. | 12 weeks (Baseline, Post-Intervention) | 
| Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores | 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. | 12 weeks (Baseline, Post-Intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced cancer, palliative, supportive oncology, psychosocial intervention