Piloting Pathways With Lung Cancer Patients

NCT04161157 | Completed Results

• 2 other identifiers: 52168R03CA235171-01A1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

  Percentage of eligible and approached patients who agree to participate

  9 months

• Acceptability: Ratings

  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).

  9 months

Secondary Outcomes (5)

• PROMIS Satisfaction With Participation in Social Roles - Short Form 8a

  9 months

• Hope - State Hope Scale (Snyder)

  9 months

• Purpose - PROMIS Meaning and Purpose 4a

  9 months

• Distress - PROMIS Depression Short Form 6a

  9 months

• Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)

  9 months

Study Arms (1)

Pathways

EXPERIMENTAL

Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.

Behavioral: Pathways

Interventions

Pathways BEHAVIORAL

Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (\~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.

Pathways

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Laurie McLouth: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Laurie McLouth
• Organization: University of Kentucky

laurie.mclouth@uky.edu

859-562-2526

Study Officials

• Laurie McLouth, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: January 13, 2020
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)