AzTrials
AzTrials

Lung CancerSCANNCT06199570

Support for Cancer Patients Awaiting News

A study testing Adapted Stress Management Program in people with Lung Cancer, run by Hackensack Meridian Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Adapted Stress Management Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 May 2024to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 at least mild anxiety (using the PROMIS Anxiety 4a) or 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda Khoudary, BA contact

2018803445

Amanda.Khoudary@hmh-cdi.org

United States1 site, 1 recruiting
  • Amanda Khoudary

    Hackensack, New Jersey, 07601

    Amanda Khoudary, 201-880-3445, Amanda.Khoudary@hmh-cdi.org

    Heather Derry-Vick, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Lung Cancer
Being tested
Adapted Stress Management Program, Enhanced Usual Care
Keywords
Stress management, Cancer related anxiety, Scan related anxiety, Advanced lung cancer, lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Stress Management ProgramBehavioural

    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 CareBehavioural

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

Study groups in NCT06199570
Study groupRoleWhat they receive
Adapted Stress Management ProgramExperimentalThe 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.
Receives: Behavioral: Adapted Stress Management Program
Enhanced Usual CareActive comparatorThose 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.
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Retention (open trial)

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

    Measured: 1-week post-scan

  2. Feasibility - Retention (pilot RCT)

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

    Measured: 3-month post-intervention

  3. Feasibility - Web module engagement (open trial)

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

    Measured: 1-week pre-scan and 1-week post-scan

  4. Feasibility - Web module engagement (pilot RCT)

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

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

  5. 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).

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

  6. 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).

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Secondary outcomes (8)
  1. Intervention engagement - Daily stress management skill practice (open trial)

    Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.

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

  2. Intervention engagement - Daily stress management skill practice (Pilot RCT)

    Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys.

    Measured: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization

  3. Anxiety (open trial)

    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.

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

  4. Anxiety (Pilot RCT)

    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.

    Measured: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization

  5. Cancer-related intrusive thoughts (open trial)

    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.

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

  6. Cancer-related intrusive thoughts (Pilot RCT)

    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.

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

  7. Stress management skills (open trial)

    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.

    Measured: 1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up

  8. Stress management skills (Pilot RCT)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start1 May 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open Trial phase: Unblinded, single-site, single-arm open trial (n=10). Pilot RCT phase: Unblinded, single-site, feasibility pilot randomized controlled trial (n=50; adapted stress management program vs. enhanced usual care).
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06199570
Sponsor's protocol ID
Pro2022-0930
Other IDs
R00CA245488
Acronym
SCAN
Status last verified
Aug 2026
First submitted
8 Dec 2023
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bauml JM, Troxel A, Epperson CN, Cohen RB, Schmitz K, Stricker C, Shulman LN, Bradbury A, Mao JJ, Langer CJ. Scan-associated distress in lung cancer: Quantifying the impact of "scanxiety". Lung Cancer. 2016 Oct;100:110-113. doi: 10.1016/j.lungcan.2016.08.002. Epub 2016 Aug 16.

    PubMed 27597289
  • Peteet JR, Stomper PC, Ross DM, Cotton V, Truesdell P, Moczynski W. Emotional support for patients with cancer who are undergoing CT: semistructured interviews of patients at a cancer institute. Radiology. 1992 Jan;182(1):99-102. doi: 10.1148/radiology.182.1.1727318.

    PubMed 1727318
  • Lai-Kwon J, Heynemann S, Flore J, Dhillon H, Duffy M, Burke J, Briggs L, Leigh L, Mileshkin L, Solomon B, Ball D, Kokanovic R, Jefford M. Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy. J Cancer Surviv. 2021 Jun;15(3):392-397. doi: 10.1007/s11764-021-01024-8. Epub 2021 Mar 31.

    PubMed 33788170
  • Mehnert A, Berg P, Henrich G, Herschbach P. Fear of cancer progression and cancer-related intrusive cognitions in breast cancer survivors. Psychooncology. 2009 Dec;18(12):1273-80. doi: 10.1002/pon.1481.

    PubMed 19267364
  • Herschbach P, Dinkel A. Fear of progression. Recent Results Cancer Res. 2014;197:11-29. doi: 10.1007/978-3-642-40187-9_2.

    PubMed 24305766
  • Shields GS, Sazma MA, Yonelinas AP. The effects of acute stress on core executive functions: A meta-analysis and comparison with cortisol. Neurosci Biobehav Rev. 2016 Sep;68:651-668. doi: 10.1016/j.neubiorev.2016.06.038. Epub 2016 Jun 28.

    PubMed 27371161
  • Derry HM, Reid MC, Prigerson HG. Advanced cancer patients' understanding of prognostic information: Applying insights from psychological research. Cancer Med. 2019 Aug;8(9):4081-4088. doi: 10.1002/cam4.2331. Epub 2019 Jun 14.

    PubMed 31199597
  • Spencer R, Nilsson M, Wright A, Pirl W, Prigerson H. Anxiety disorders in advanced cancer patients: correlates and predictors of end-of-life outcomes. Cancer. 2010 Apr 1;116(7):1810-9. doi: 10.1002/cncr.24954.

    PubMed 20187099
  • Derry HM, Maciejewski PK, Epstein AS, Shah MA, LeBlanc TW, Reyna V, Prigerson HG. Associations between Anxiety, Poor Prognosis, and Accurate Understanding of Scan Results among Advanced Cancer Patients. J Palliat Med. 2019 Aug;22(8):961-965. doi: 10.1089/jpm.2018.0624. Epub 2019 Feb 6.

    PubMed 30724692
  • Jacobsen PB, Meade CD, Stein KD, Chirikos TN, Small BJ, Ruckdeschel JC. Efficacy and costs of two forms of stress management training for cancer patients undergoing chemotherapy. J Clin Oncol. 2002 Jun 15;20(12):2851-62. doi: 10.1200/JCO.2002.08.301.

    PubMed 12065562
  • Osborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatry Med. 2006;36(1):13-34. doi: 10.2190/EUFN-RV1K-Y3TR-FK0L.

    PubMed 16927576
  • Tatrow K, Montgomery GH. Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: a meta-analysis. J Behav Med. 2006 Feb;29(1):17-27. doi: 10.1007/s10865-005-9036-1. Epub 2006 Jan 7.

    PubMed 16400532
  • Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. J Clin Oncol. 2013 Feb 20;31(6):782-93. doi: 10.1200/JCO.2011.40.8922. Epub 2013 Jan 14.

    PubMed 23319686
  • Brothers BM, Yang HC, Strunk DR, Andersen BL. Cancer patients with major depressive disorder: testing a biobehavioral/cognitive behavior intervention. J Consult Clin Psychol. 2011 Apr;79(2):253-60. doi: 10.1037/a0022566.

    PubMed 21341891
  • Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, Yount SE, McGregor BA, Arena PL, Harris SD, Price AA, Carver CS. Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol. 2001 Jan;20(1):20-32. doi: 10.1037//0278-6133.20.1.20.

    PubMed 11199062

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Stress Management Program in people with Lung Cancer, run by Hackensack Meridian Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amanda Khoudary, BA (2018803445, Amanda.Khoudary@hmh-cdi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Retention (open trial) (time frame: 1-week post-scan). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06199570, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in