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NCT04161157

Piloting Pathways With Lung Cancer Patients

Completed NA Results posted Last updated 5 October 2023
What this trial tests

NA trial testing Pathways in Metastatic Lung Cancer in 53 participants. Completed in 3 August 2022.

Timeline
13 January 2020
Primary endpoint
3 August 2022
3 August 2022

Quick facts

Lead sponsorLaurie McLouth
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment53
Start date13 January 2020
Primary completion3 August 2022
Estimated completion3 August 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Laurie McLouth

Who can join

18 and older, any sex, with Metastatic Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate Primary · 9 months

Percentage of eligible and approached patients who agree to participate

GroupValue95% CI
Pathways53
Acceptability: Ratings Primary · 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).

Convenience of intervention
GroupValue95% CI
Pathways8.79± 1.17
Relevance of intervention
GroupValue95% CI
Pathways8.46± 1.67
Helpfulness of intervention
GroupValue95% CI
Pathways8.54± 1.55
PROMIS Satisfaction With Participation in Social Roles - Short Form 8a Secondary · 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.

GroupValue95% CI
Pathways21.8± 9.54
Hope - State Hope Scale (Snyder) Secondary · 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.

GroupValue95% CI
Pathways31.3± 7.9
Purpose - PROMIS Meaning and Purpose 4a Secondary · 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.

GroupValue95% CI
Pathways16.4± 3.7
Distress - PROMIS Depression Short Form 6a Secondary · 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.

GroupValue95% CI
Pathways11.3± 5.87
Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann) Secondary · 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.

GroupValue95% CI
Pathways52± 15.7

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Developing pathways, a hope-enhancing intervention for metastatic lung cancer patients receiving cancer treatment.
    McLouth LE, Weyman K, Golden SL, Cheavens JS, et al · · 2021 · cited 7× · PMID 33638288 · DOI 10.1002/pon.5650
  2. "Pathways": A hope-enhancing intervention for patients undergoing treatment for advanced lung cancer.
    McLouth LE, Shelton BJ, Bursac V, Burris JL, et al · · 2024 · cited 5× · PMID 38446540 · DOI 10.1002/pon.6316

Verify or expand the search:

Other trials of Pathways

Trials testing the same drug.

Other recruiting trials for Metastatic Lung Cancer

Currently open trials in the same condition.

Other Laurie McLouth trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04161157.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing