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Completed

NCT Number: NCT04161157

Piloting Pathways With Lung Cancer Patients

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.

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Key information

Conditions

Metastatic Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

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

    Time frame: 9 months

    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.

  2. Hope - State Hope Scale (Snyder)

    Time frame: 9 months

    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.

  3. Purpose - PROMIS Meaning and Purpose 4a

    Time frame: 9 months

    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.

  4. Distress - PROMIS Depression Short Form 6a

    Time frame: 9 months

    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.

  5. Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)

    Time frame: 9 months

    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.

Sponsors and collaborators

Lead sponsor

Laurie McLouth

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2019
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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