Support for Cancer Patients Awaiting News

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Feasibility - Retention (open trial) [Срок оценки: 1-week post-scan]
• Feasibility - Retention (pilot RCT) [Срок оценки: 3-month post-intervention]
• Feasibility - Web module engagement (open trial) [Срок оценки: 1-week pre-scan and 1-week post-scan]
• Feasibility - Web module engagement (pilot RCT) [Срок оценки: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]
• Acceptability of Intervention - Overall (open trial) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Acceptability of Intervention - Overall (pilot RCT) [Срок оценки: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]
• Acceptability - Perceived helpfulness (open trial) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Acceptability - Perceived helpfulness (Pilot RCT) [Срок оценки: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]
• Acceptability - Usability (open trial) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Acceptability - Usability (Pilot RCT) [Срок оценки: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]

Вторичные конечные точки (8)

• Intervention engagement - Daily stress management skill practice (open trial) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Intervention engagement - Daily stress management skill practice (Pilot RCT) [Срок оценки: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization]
• Anxiety (open trial) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Anxiety (Pilot RCT) [Срок оценки: 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) [Срок оценки: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up]
• Cancer-related intrusive thoughts (Pilot RCT) [Срок оценки: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]
• Stress management skills (open trial) [Срок оценки: 1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up]
• Stress management skills (Pilot RCT) [Срок оценки: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Amanda Khoudary — Hackensack

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 20187099

Идентификаторы

NCT: NCT06199570 · Pro2022-0930 · R00CA245488

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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