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Piloting Pathways With Lung Cancer Patients

Primary Purpose

Metastatic Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pathways
Sponsored by
Laurie McLouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pathways

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
Percentage of eligible and approached patients who agree to participate
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 8, 2019
Last Updated
October 3, 2023
Sponsor
Laurie McLouth
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04161157
Brief Title
Piloting Pathways With Lung Cancer Patients
Official Title
Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laurie McLouth
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pathways
Arm Type
Experimental
Arm Description
Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma.
Intervention Type
Behavioral
Intervention Name(s)
Pathways
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
Description
Percentage of eligible and approached patients who agree to participate
Time Frame
9 months
Title
Acceptability: Ratings
Description
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).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
PROMIS Satisfaction With Participation in Social Roles - Short Form 8a
Description
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.
Time Frame
9 months
Title
Hope - State Hope Scale (Snyder)
Description
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.
Time Frame
9 months
Title
Purpose - PROMIS Meaning and Purpose 4a
Description
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.
Time Frame
9 months
Title
Distress - PROMIS Depression Short Form 6a
Description
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.
Time Frame
9 months
Title
Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie McLouth, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Piloting Pathways With Lung Cancer Patients

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