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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Pathways; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurie McLouth, PhD; Phone Number: 859-562-2526; Email: laurie.mclouth@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
      • Contact: Laurie McLouth, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Laurie McLouth
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Laurie McLouth, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: psychosocial intervention; advanced cancer; palliative; supportive oncology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 87901; 1R01CA283929-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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."

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No