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Behavioral Intervention
Stress Management for Lung Cancer Patients (SCAN Trial)
N/A
Recruiting
Led By Heather Derry-Vick, PhD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
Adult (ages 18 and older)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-week pre-scan, 1-week post-scan, and 1-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a stress management program for people with cancer who are having regular cancer scans. The study will have two phases of testing. The first phase will test the program and make any necessary changes
Who is the study for?
This trial is for lung cancer patients awaiting scan results. Participants should be willing to undergo a stress management program or receive enhanced usual care. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.
What is being tested?
The study tests a new stress management intervention against enhanced usual care in two phases: an initial Open Trial with 10 people to refine the program, followed by a Pilot Randomized Controlled Trial with 50 people to assess feasibility.
What are the potential side effects?
Since this is a behavioral trial focusing on stress management techniques rather than medication or medical procedures, side effects are minimal and may include discomfort from discussing personal experiences or feelings during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My lung cancer is at stage IV or is extensive stage small cell.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-week pre-scan, 1-week post-scan, and 1-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-week pre-scan, 1-week post-scan, and 1-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability - Perceived helpfulness
Acceptability - Usability
Acceptability of Intervention - Overall
+2 moreSecondary study objectives
Anxiety
Cancer-related intrusive thoughts
Intervention engagement - Daily stress management skill practice
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted Stress Management ProgramExperimental Treatment1 Intervention
The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist (at baseline/orientation, pre-scan, and post-scan time points) and program modules consisting of psychoeducation and stress management skill activities/practice. They will also be provided with a list of mental health resources and crisis line information for use if needed.
Group II: Enhanced Usual CareActive Control1 Intervention
Those randomized to enhanced usual care in the pilot RCT (n=25) will receive a resource list, tablet for study assessments, and reminder calls, but will not receive the program modules. They will also be provided with a list of mental health resources and crisis line information for use if needed.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,520 Total Patients Enrolled
Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,262 Total Patients Enrolled
Heather Derry-Vick, PhDPrincipal InvestigatorHackensack Meridian Health