Support for Cancer Patients Awaiting News
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adapted Stress Management Program
- Enhanced Usual Care
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hackensack Meridian Health
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov