Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult (ages 18 and older)

• Comfortable speaking, reading, and writing English without an interpreter

• Established diagnosis of Stage III-IV lung cancer (or extensive stage small cell lung cancer)

• ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2

• Receiving ongoing care from collaborating clinics with regular scans

• Receiving systemic treatment for lung cancer

• Endorse appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study)

• Willingness to use the study website

Locations
United States
New Jersey
Amanda Khoudary
RECRUITING
Hackensack
Contact Information
Primary
Amanda Khoudary, BA
Amanda.Khoudary@hmh-cdi.org
2018803445
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Adapted Stress Management Program
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.
Active_comparator: Enhanced Usual Care
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.
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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