Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06047301 | RECRUITING | Lung Cancer

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

Laurie McLouth

Information provided by (Responsible Party):

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.

Condition or disease

Lung Cancer

Intervention/treatment

Pathways

Enhanced Usual Care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 234 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
Actual Study Start Date : 2023-11-29
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Location Details

NCT06047301

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40506