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

NCT ID: NCT06199570Sponsor: Hackensack Meridian HealthLast updated: 2026-02-19

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).

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.

Arms & interventions

  • BehavioralAdapted 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.

  • BehavioralEnhanced Usual Care

    Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.

Outcome measures

Primary

  • Feasibility - Retention (open trial)

    Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.

    Time frame: 1-week post-scan

  • Feasibility - Retention (pilot RCT)

    Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.

    Time frame: 3-month post-intervention

  • Feasibility - Web module engagement (open trial)

    Percentage of intervention arm participants who completed at least 70% of the web modules.

    Time frame: 1-week pre-scan and 1-week post-scan

  • Feasibility - Web module engagement (pilot RCT)

    Percentage of intervention arm participants who completed at least 70% of the web modules.

    Time frame: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

  • Acceptability of Intervention - Overall (open trial)

    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).

    Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up

  • Acceptability of Intervention - Overall (pilot RCT)

    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).

    Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

  • Acceptability - Perceived helpfulness (open trial)

    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.

    Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up

  • Acceptability - Perceived helpfulness (Pilot RCT)

    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.

    Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

  • Acceptability - Usability (open trial)

    Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.

    Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up

  • Acceptability - Usability (Pilot RCT)

    Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.

    Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

Secondary

  • Intervention engagement - Daily stress management skill practice (open trial)

    Time frame: 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

  • Anxiety (open trial)

    Time frame: 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

  • 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 (Pilot RCT)

    Time frame: 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

  • Stress management skills (Pilot RCT)

    Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Amanda Khoudary

Hackensack, New Jersey, 07601

Recruiting
Amanda Khoudary · Contact
201-880-3445Amanda.Khoudary@hmh-cdi.org
Heather Derry-Vick, PhD · Principal Investigator

References

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