NCT06199570 · Hackensack Meridian Health
Support for Cancer Patients Awaiting News
(SCAN)
What this study is about
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 randomly assigned Controlled Trial phase.
View original scientific description
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).
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.
Primary outcome measures
Feasibility - Retention (open trial)
Time frame: 1-week post-scan
Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.
Feasibility - Retention (pilot RCT)
Time frame: 3-month post-intervention
Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.
Feasibility - Web module engagement (open trial)
Time frame: 1-week pre-scan and 1-week post-scan
Percentage of intervention arm participants who completed at least 70% of the web modules.
Feasibility - Web module engagement (pilot RCT)
Time frame: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Percentage of intervention arm participants who completed at least 70% of the web modules.
Acceptability of Intervention - Overall (open trial)
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Percentage of intervention arm participants with mean ratings ≥4 on the validated Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. Acceptability will be assessed via participant ratings (mean scores ranging from 1 to 5, with higher scores indicating better acceptability).
Acceptability of Intervention - Overall (pilot RCT)
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Percentage of intervention arm participants with mean ratings ≥4 on the validated Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. Acceptability will be assessed via participant ratings (mean scores ranging from 1 to 5, with higher scores indicating better acceptability).
Acceptability - Perceived helpfulness (open trial)
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Percentage of intervention arm participants with ratings ≥4 on a 1-5 Likert item assessing perceived helpfulness of the intervention. Higher scores indicate greater perceived helpfulness.
Acceptability - Perceived helpfulness (Pilot RCT)
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Percentage of intervention arm participants with ratings ≥4 on a 1-5 Likert item assessing perceived helpfulness of the intervention. Higher scores indicate greater perceived helpfulness.
Acceptability - Usability (open trial)
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.
Acceptability - Usability (Pilot RCT)
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Hackensack, New Jersey
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations