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RECRUITING
NCT06199570
NA

Support for Cancer Patients Awaiting News

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-05-01

Completion Date

2026-12-30

Last Updated

2026-02-19

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Adapted Stress Management Program

Participants will receive a 15-minute orientation session in-person or remotely to introduce the program and to receive the study materials, including the instructional sheet, small booklet, and study tablet that will be used to promote practice of stress management exercises and for completing study assessments. They will complete self-guided web modules with stress management activities/skills on tablet devices, and will rate the modules' acceptability and perceived helpfulness. After visiting each module, they will be asked to practice at least one skill daily. In a second coaching session, they will be reminded about the skills, make a plan for using them, and troubleshoot questions about using the materials. Participants will attend scans and scan result appointments with their oncologist as usual. In a third coaching session, the stress management plan will be revisited for new concerns.

BEHAVIORAL

Enhanced Usual Care

Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.

Locations (1)

Amanda Khoudary

Hackensack, New Jersey, United States