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Clinical Trials/NCT04161157
NCT04161157
Completed
Not Applicable

Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients

Laurie McLouth1 site in 1 country53 target enrollmentJanuary 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Lung Cancer
Sponsor
Laurie McLouth
Enrollment
53
Locations
1
Primary Endpoint
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with advanced stage and metastatic lung cancer.

Detailed Description

In this study, investigators will first test the Pathways procedures with 6 patients to identify any improvements that need to be made. Then, investigators will test the feasibility of the Pathways intervention with 20 patients who are undergoing cancer treatment for advanced stage or metastatic lung cancer. Pathways is designed to help patients set and pursue personal goals during lung cancer treatment. In this study, investigators want to see if they can recruit patients with lung cancer who are being treated at the University of Kentucky Markey Cancer Center to participate in the Pathways intervention.

Registry
clinicaltrials.gov
Start Date
January 13, 2020
End Date
August 3, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Laurie McLouth
Responsible Party
Sponsor Investigator
Principal Investigator

Laurie McLouth

Assistant Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • new or recurrent stage IIIB, stage IIIC or stage IV non-small cell lung cancer (NSCLC) or extensive stage SCLC
  • 18 years of age or older
  • ECOG PS 0-2/Karnofsky 60-100
  • 3 to 12 weeks into active cancer treatment

Exclusion Criteria

  • unstable brain metastases
  • cognitive or psychiatric condition for which participating would be inappropriate
  • unable to speak and read English

Outcomes

Primary Outcomes

Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate

Time Frame: 9 months

Percentage of eligible and approached patients who agree to participate

Acceptability: Ratings

Time Frame: 9 months

Mean acceptability ratings on individual items of acceptability developed by study team (e.g., convenience of the intervention, helpfulness of the intervention, relevance of the intervention; scores of at least 7/10 on each item, possible range = 1-10, higher scores indicate higher acceptability).

Secondary Outcomes

  • Hope - State Hope Scale (Snyder)(9 months)
  • Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)(9 months)
  • Purpose - PROMIS Meaning and Purpose 4a(9 months)
  • PROMIS Satisfaction With Participation in Social Roles - Short Form 8a(9 months)
  • Distress - PROMIS Depression Short Form 6a(9 months)

Study Sites (1)

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