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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks (baseline, post-intervention)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have felt significant distress or psychological discomfort recently.

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I am 18 years old or older.

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I started my infusion treatment for cancer between 3 to 12 weeks ago.

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My lung cancer is at an advanced stage.

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I am mostly able to carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (baseline, post-intervention)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PROMIS Depression Short Form Scores

Change in State Hope scores

Secondary outcome measures

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laurie McLouthLead Sponsor

3 Previous Clinical Trials

173 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,675 Previous Clinical Trials

40,926,743 Total Patients Enrolled

Laurie McLouth, PhDPrincipal InvestigatorUniversity of Kentucky

2 Previous Clinical Trials

133 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any recruitment efforts underway for this experiment?

"This study, which was initially made available on November 30th 2023 and most recently edited on September 14th 2023, is not currently accepting participants. Nevertheless, there are 1649 other clinical trials actively recruiting patients as of now."

Answered by AI

What are the primary goals of this medical experiment?

"The objective of this 12-week assessment is to analyse the alteration in scores from initial State Hope tests. Secondary evaluations include changes in Demoralization Scale II, PROMIS 15a Positive Affect and FACIT Spiritual Wellbeing Meaning/Peace Subscale assessments; these are measured from 0 (never) - 4 (very much), with higher scores indicating greater presence of demoralisation, positivity or meaning/peace respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Laurie McLouth 2023. "Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047301.