Lung CancerNCT06047301
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment
A study testing Pathways in people with Lung Cancer, run by Laurie McLouth at 1 site in United States.
Trial summary
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pathways
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100
- 3-12 weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
- Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items.
Who cannot join
- Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses)
- Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
- Receiving overlapping palliative care or psychological services at the cancer center
- Unable to speak and read English.
- Hearing or visual impairment that precludes study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Laurie McLouth, PhD
About this study
Official title: Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.
- Conditions
- Lung Cancer
- Being tested
- Pathways, Enhanced Usual Care
- Keywords
- advanced cancer, palliative, supportive oncology, psychosocial intervention
- 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
Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.
Enhanced Usual CareBehavioural
Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.
| Study group | Role | What they receive |
|---|---|---|
| Pathways | Experimental | Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer. Receives: Behavioral: Pathways |
| Enhanced Usual Care | Active comparator | Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center). Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS Depression Short Form Scores
Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30.
Higher scores indicate more depression.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in State Hope scores
Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.
Measured: 12 weeks (Baseline, Post-Intervention)
Secondary outcomes (6)
Change in PROMIS Anxiety Short Form Scores
Anxiety symptoms are measured using the PROMIS Anxiety Short Form 4a. 4 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 4 to 20. Higher scores indicate more anxiety.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in Demoralization Scale II Scores
Demoralization symptoms are measured using the Demoralization Scale II: 16 items are responded to on a scale of 0 = never to 2 = always; Raw scores range from 0-32. Higher scores indicate more demoralization.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS 15a positive affect scores
Positive affect is measured using the PROMIS 15a positive affect form. Higher scores indicate more positive affect. Items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 15 to 45. Higher scores indicate more positive affect.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
Meaning/Peace is measured using the FACIT-Spiritual Well-being Meaning/Peace Subscale. 8 items are responded to on a scale of 0 = not at all to 4 = very much. Raw scores range from 0-32. Higher scores indicate more meaning/peace.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in FACT-G7 Quality of Life Scores
Quality of Life is measured using the FACT-G7. 7 items are responded to on a scale of 0 = not at all to 4 = very much to assess physical, emotional, and functional wellbeing. Raw scores range from 0 to 28. Higher scores indicate better quality of life.
Measured: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores
Satisfaction with Social Activities and Roles is measured using the ROMIS Satisfaction with Participation in Social Roles 8a Short Form. 8 items are responded to on a scale of 1 = not at all to 5 = very much. Raw scores range from 8 to 40. Higher scores indicate better function.
Measured: 12 weeks (Baseline, Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Nov 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
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
- NCT06047301
- Sponsor's protocol ID
- 87901
- Other IDs
- 1R01CA283929-01
- Status last verified
- May 2026
- First submitted
- 14 Sep 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Description: The proposed research will include clinical and patient-reported outcome data from approximately 234 participants with advanced stage lung cancer. Patients will complete surveys prior to randomization, mid-intervention period, post-intervention, and at follow-ups. In addition to these survey data, disease and medical treatment information will be abstracted from the electronic health record, including cancer treatments received, performance status, hospitalizations, and death. Data Archive: Data from this study will be submitted to ICPSR (Inter-university Consortium for Political and Social Research), which will make de-identified data available as described under "access criteria."
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06047301
- Acronym / sponsor ID
- 87901
- Conditions
- Lung Cancer
- Keywords
- advanced cancer, palliative, supportive oncology, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Laurie McLouthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathways | Experimental | Behavioral: PathwaysPathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareEnhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100
- 3-12 weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
- Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items.
Key exclusion criteria (5 listed)
- Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses)
- Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
- Receiving overlapping palliative care or psychological services at the cancer center
- Unable to speak and read English.
- Hearing or visual impairment that precludes study participation
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 |
|---|---|---|
| PathwaysDelivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources. | Behavioural | Pathways |
| Enhanced Usual CarePathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents. | Behavioural | Enhanced Usual Care |
Primary outcome
Change in PROMIS Depression Short Form Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30. Higher scores indicate more depression.
Change in State Hope scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.
6 secondary outcomes
Change in PROMIS Anxiety Short Form Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in Demoralization Scale II Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS 15a positive affect scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in FACT-G7 Quality of Life Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. Data Description: The proposed research will include clinical and patient-reported outcome data from approximately 234 participants with advanced stage lung cancer. Patients will complete surveys prior to randomization, mid-intervention period, post-intervention, and at follow-ups. In addition to these survey data, disease and medical treatment information will be abstracted from the electronic health record, including cancer treatments received, performance status, hospitalizations, and death. Data Archive: Data from this study will be submitted to ICPSR (Inter-university Consortium for Political and Social Research), which will make de-identified data available as described under "access criteria."
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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.
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 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie McLouth, PhD (859-562-2526, laurie.mclouth@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Depression Short Form Scores (time frame: 12 weeks (Baseline, Post-Intervention)). 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 8 May 2026.