Metastatic Lung CancerNCT04161157
Piloting Pathways With Lung Cancer Patients
A study testing Pathways in people with Metastatic Lung Cancer, run by Laurie McLouth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Cancer
- What is being tested?
- Pathways
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 3 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unstable brain metastases
- cognitive or psychiatric condition for which participating would be inappropriate
- unable to speak and read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic 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.
Read the 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.
- Conditions
- Metastatic Lung Cancer
- Being tested
- Pathways
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PathwaysBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pathways | Experimental | Pathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. Receives: Behavioral: Pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate
Percentage of eligible and approached patients who agree to participate
Measured: 9 months
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).
Measured: 9 months
Secondary outcomes (5)
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start13 Jan 2020
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurie McLouth
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Laurie McLouth, University of Kentucky
- Investigators
- Laurie McLouth, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161157
- Sponsor's protocol ID
- 52168
- Other IDs
- R03CA235171-01A1
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2019
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Pathways, a Hope-enhancing Intervention to Address Activity and Role Function in Metastatic Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04161157
- Acronym / sponsor ID
- 52168
- Conditions
- Metastatic Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Laurie McLouthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathways | Experimental | Behavioral: PathwaysPathways is designed to help patients identify and pursue values-based goals and address potential goal obstacles, including lung cancer stigma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- unstable brain metastases
- cognitive or psychiatric condition for which participating would be inappropriate
- unable to speak and read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PathwaysGoal-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. | Behavioural | Pathways |
Primary outcome
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
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).
5 secondary outcomes
PROMIS Satisfaction With Participation in Social Roles - Short Form 8a
Time frame: 9 months
Hope - State Hope Scale (Snyder)
Time frame: 9 months
Purpose - PROMIS Meaning and Purpose 4a
Time frame: 9 months
Distress - PROMIS Depression Short Form 6a
Time frame: 9 months
Lung Cancer Stigma - Lung Cancer Stigma Inventory (Hamann)
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie McLouth, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways in people with Metastatic Lung Cancer, run by Laurie McLouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment: Percentage of Eligible and Approached Patients Who Agree to Participate (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.