Clinical trial · Interventional
Support for Cancer Patients Awaiting News
Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
NCT06199570CI-TRIAL-00120427SCANrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adapted Stress Management Program | Behavioral | — | UNRESOLVED |
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adapted Stress Management Program
- description
- 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.
- interventionNames
- Behavioral: Adapted Stress Management Program
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- 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.
- interventionNames
- Behavioral: Enhanced Usual Care
Primary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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) 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)
References
Publications (33)
- BACKGROUNDBauml 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. PMID 27597289
- BACKGROUNDPeteet 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. PMID 1727318
- BACKGROUNDLai-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. PMID 33788170
- BACKGROUNDMehnert 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. PMID 19267364
- BACKGROUNDHerschbach P, Dinkel A. Fear of progression. Recent Results Cancer Res. 2014;197:11-29. doi: 10.1007/978-3-642-40187-9_2. PMID 24305766
- BACKGROUNDShields 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. PMID 27371161
- BACKGROUNDDerry 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.