Piloting Pathways With Lung Cancer Patients

Metastatic Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161157
• Other study ID #: 52168
• Secondary ID: R03CA235171-01A1
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Metastatic Lung Cancer

Intervention

Behavioral:
• Pathways
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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Laurie McLouth	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PROMIS Satisfaction With Participation in Social Roles - Short Form 8a	Brief measure of satisfaction with ability and participation in activities and roles (e.g., work at home, regular personal and household responsibilities, do things for family) Higher scores indicate more satisfaction with participation. Raw scores range from 8 to 40. 8 items are responded to on a scale of 1 = not at all to 5 = very much.	9 months
Secondary	Hope - State Hope Scale (Snyder)	Brief measure of agency and pathways thinking. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Items are summed for a total score (possible range = 6 - 48). Higher scores indicate higher hope.	9 months
Secondary	Purpose - PROMIS Meaning and Purpose 4a	Brief measure assessing one's sense of purpose and that there are reasons for living; 4 items responded to on a scale of 1 = not at all to 5 = very much (possible raw score range = 4 - 20). Higher scores indicate greater meaning and purpose.	9 months
Secondary	Distress - PROMIS Depression Short Form 6a	Brief measure assessing sense of worthlessness, helplessness, depression, etc. 6 items are responded to on a scale of 1 = never to 5 = always (possible raw scores range from 6-30). Higher scores indicate greater distress.	9 months
Secondary	Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)	measure of lung cancer stigma. 25 items making up three subscales (perceived stigma, internalized stigma, and constrained disclosure). Items are responded to on a scale of 1 = not at all to 5 = extremely. Items are summed, with a higher score indicating greater lung cancer stigma/worse outcome (possible total score range = 25-125) . Clinical cutoff of a total score of 37.5 is suggested in literature as significant levels of stigma.	9 months