Piloting Pathways With Lung Cancer Patients

NCT ID: NCT04161157

Last Updated: 2023-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-08-03

Brief Summary

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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

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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.

Conditions

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Metastatic Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pathways

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

Group Type EXPERIMENTAL

Pathways

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Laurie McLouth

OTHER

Sponsor Role lead

Responsible Party

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Laurie McLouth

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Laurie McLouth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R03CA235171-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

52168

Identifier Type: -

Identifier Source: org_study_id

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