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Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT06199570
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adapted Stress Management Program — BEHAVIORAL
    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.
  • Enhanced Usual Care — BEHAVIORAL
    Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.

Study Details

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).

Key Dates

Start date
May 1, 2024
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adapted Stress Management Program
    The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist 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.

Primary Outcome Measure

Feasibility - Retention (open trial) [ Time Frame: 1-week post-scan ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amanda KhoudaryHackensackNew Jersey07601
Amanda Khoudary
[email protected]
201-880-3445
Heather Derry-Vick, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Hackensack, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Amanda Khoudary· Hackensack, NJ

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