RecruitingNot ApplicableNCT06047301

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


Sponsor

Laurie McLouth

Enrollment

234 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria5

  • 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

Interventions

BEHAVIORALPathways

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.

BEHAVIORALEnhanced 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.


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

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NCT06047301


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