← Back to Search

Behavioral Intervention

Hope Intervention for Advanced Lung Cancer

N/A
Recruiting
Led By Laurie McLouth, PhD
Research Sponsored by Laurie McLouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
18 years of age or older
Must not have
Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses)
Receiving overlapping palliative care or psychological services at the cancer center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (baseline, post-intervention)
Awards & highlights

Summary

This trial will compare a brief intervention (Pathways) to usual care in advanced lung cancer patients to see how it affects their mental health and quality of life. Surveys will be used to track changes.

Who is the study for?
This trial is for adults over 18 with advanced lung cancer who are already a few weeks into infusion-based treatment. They should be experiencing some distress but not have severe cognitive or psychiatric conditions, unstable brain metastases, or be receiving similar care elsewhere.
What is being tested?
The study tests 'Pathways', a supportive intervention aimed at improving mental health and quality of life during advanced lung cancer treatment, against enhanced usual care. Participants will answer surveys before and after the intervention to measure its impact.
What are the potential side effects?
Since 'Pathways' is a psychological support intervention rather than a drug, it may not have typical medical side effects. However, discussing personal goals and mental health could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have felt significant distress or psychological discomfort recently.
Select...
I am 18 years old or older.
Select...
I started my infusion treatment for cancer between 3 to 12 weeks ago.
Select...
My lung cancer is at an advanced stage.
Select...
I am mostly able to carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My brain metastases are stable; I don't have worsening symptoms, uncontrolled seizures, or increasing need for steroids.
Select...
I am getting supportive care or mental health services at the cancer center.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (baseline, post-intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (baseline, post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PROMIS Depression Short Form Scores
Change in State Hope scores
Secondary study objectives
Change in Demoralization Scale II Scores
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
Change in FACT-G7 Quality of Life Scores
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PathwaysExperimental Treatment1 Intervention
Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
Group II: Enhanced Usual CareActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pathways
2020
N/A
~1140

Find a Location

Who is running the clinical trial?

Laurie McLouthLead Sponsor
3 Previous Clinical Trials
178 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,766 Total Patients Enrolled
Laurie McLouth, PhDPrincipal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
128 Total Patients Enrolled
~156 spots leftby Dec 2027