Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-05-01
2026-12-30
Brief Summary
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Detailed Description
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The goal of this study is to pilot test an adapted stress management program to help patients manage their anxiety while awaiting scan results. The program is a behavioral intervention that includes psychoeducation and stress management activities, delivered via a web platform to promote dissemination. In the Open Trial phase, the program will be field tested in a single-arm trial, using feedback to refine materials and procedures as needed before formal piloting. In the Pilot RCT phase, a small RCT will be conducted to test the intervention's feasibility and acceptability and to examine preliminary effects on anxiety and other secondary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
Enhanced Usual Care
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
Interventions
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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.
Enhanced Usual Care
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
Eligibility Criteria
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Inclusion Criteria
2. Comfortable speaking, reading, and writing English without an interpreter
3. Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer)
4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
5. Receiving ongoing care from collaborating clinics with regular scans
6. Receiving systemic treatment for lung cancer
7. 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)
8. Willingness to use the study website
Exclusion Criteria
2. Requires an interpreter for medical visits
3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
4. Currently enrolled in hospice
5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Heather Derry-Vick, PhD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Amanda Khoudary
Hackensack, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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Pro2022-0930
Identifier Type: -
Identifier Source: org_study_id
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