Support for Cancer Patients Awaiting News (SCAN)

February 17, 2026 updated by: Hackensack Meridian Health

Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer patients repeatedly undergo routine scans that inform their disease status and treatment. While awaiting the results, anxiety and uncertainty are elevated, which can negatively impact quality of life. Evidence-based stress management strategies have the potential to be useful during this unique time period, but require tailoring for this population and context.

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Amanda Khoudary
        • Contact:
        • Principal Investigator:
          • Heather Derry-Vick, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult (ages 18 and older)
  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:

  1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)
  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Enhanced Usual Care
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Retention (open trial)
Time Frame: 1-week post-scan
Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.
1-week post-scan
Feasibility - Retention (pilot RCT)
Time Frame: 3-month post-intervention
Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.
3-month post-intervention
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.
1-week pre-scan and 1-week post-scan
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.
Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
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).
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
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).
post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
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.
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
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.
post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
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.
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
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.
post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention engagement - Daily stress management skill practice (open trial)
Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Intervention engagement - Daily stress management skill practice (Pilot RCT)
Time Frame: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys.
Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Anxiety (open trial)
Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Anxiety will be measured via the validated PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 8a survey. T-scores range from 31.7 to 83.1, with higher scores indicating greater anxiety.
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Anxiety (Pilot RCT)
Time Frame: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 4a survey using brief end-of-day surveys. T-scores range from 40.3 to 81.6 with higher scores indicating higher anxiety.
Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Cancer-related intrusive thoughts (open trial)
Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Cancer-related intrusive thoughts will be measured via validated the Impact of Events 6 item short form survey. Scores range from 0 to 24, with higher scores indicating higher levels of cancer-related intrusive thoughts.
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Cancer-related intrusive thoughts (Pilot RCT)
Time Frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Cancer-related intrusive thoughts will be measured via validated the Impact of Events 6 item short form survey. Scores range from 0 to 24, with higher scores indicating higher levels of cancer-related intrusive thoughts.
post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Stress management skills (open trial)
Time Frame: 1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up
Perceived stress management skill will be measured via the validated Measure of Current Status survey. Total scores range from 0 to 52 with higher scores indicating better stress management skills.
1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up
Stress management skills (Pilot RCT)
Time Frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Perceived stress management skill will be measured via the validated Measure of Current Status survey. Total scores range from 0 to 52 with higher scores indicating better stress management skills.
post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Heather Derry-Vick, PhD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2022-0930
  • R00CA245488 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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