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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Amanda Khoudary
Hackensack, New Jersey, 07601
Amanda Khoudary, 201-880-3445, Amanda.Khoudary@hmh-cdi.org
Heather Derry-Vick, PhD
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 group | Role | What they receive |
|---|---|---|
| Adapted Stress Management Program | Experimental | 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. Receives: Behavioral: Adapted Stress Management Program |
| Enhanced Usual Care | Active comparator | 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Retention (open trial)
Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.
Measured: 1-week post-scan
Feasibility - Retention (pilot RCT)
Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.
Measured: 3-month post-intervention
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
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)
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
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)
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
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)
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
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)
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
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
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
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
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
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)
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
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.
- First posted10 Jan 2024
- Study start1 May 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather Derry-Vick, PhD, Principal investigator, Hackensack Meridian Health
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 27597289Peteet 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 1727318Lai-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 33788170Mehnert 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 19267364Herschbach P, Dinkel A. Fear of progression. Recent Results Cancer Res. 2014;197:11-29. doi: 10.1007/978-3-642-40187-9_2.
PubMed 24305766Shields 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 27371161Derry 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 31199597Spencer 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 20187099Derry 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 30724692Jacobsen 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 12065562Osborn 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 16927576Tatrow 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 16400532Faller 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 23319686Brothers 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 21341891Antoni 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
- ClinicalTrials.gov ID
- NCT06199570
- Acronym / sponsor ID
- SCAN / Pro2022-0930
- Conditions
- Lung Cancer
- Keywords
- Stress management, Cancer related anxiety, Scan related anxiety, Advanced lung cancer, lung cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Adapted Stress Management Program | Experimental | Behavioral: Adapted Stress Management ProgramThe 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Stress Management ProgramParticipants 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. | Behavioural | Adapted Stress Management Program |
| Enhanced Usual CareEnhanced usual care includes a resource list, tablet for study assessments, and reminder calls. | Behavioural | Enhanced Usual Care |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 27597289Bauml 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.
- Background: PubMed 1727318Peteet 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.
- Background: PubMed 33788170Lai-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.
- Background: PubMed 19267364Mehnert 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.
- Background: PubMed 24305766Herschbach P, Dinkel A. Fear of progression. Recent Results Cancer Res. 2014;197:11-29. doi: 10.1007/978-3-642-40187-9_2.
- Background: PubMed 27371161Shields 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.
- Background: PubMed 31199597Derry 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.
- Background: PubMed 20187099Spencer 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.
- Background: PubMed 30724692Derry 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.
- Background: PubMed 12065562Jacobsen 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.
- Background: PubMed 16927576Osborn 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.
- Background: PubMed 16400532Tatrow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Derry-Vick, PhD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
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.