Support for Cancer Patients Awaiting News
Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
Hackensack Meridian Health
60 participants
May 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Adult (ages 18 and older)
- Comfortable speaking, reading, and writing English without an interpreter
- Established diagnosis of lung cancer (3a. Open Trial phase only: 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
Exclusion Criteria5
- Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)
- Requires an interpreter for medical visits
- Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
- Currently enrolled in hospice
- Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)
Interventions
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 includes a resource list, tablet for study assessments, and reminder calls.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06199570