Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

Официальное название

Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

Обзор

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

Подробное описание

The primary objective of this study is to compare 2-year compliance with the personalized post-treatment surveillance plan between the two arms.

The secondary objectives are to compare between the two arms :

* Long-term compliance (5-year follow-up) * Use of care * Oncological events and their management * Supportive care needs

The exploratory objectives are to :

* Evaluate the costs in terms of medical transportation * Evaluate and compare patients' satisfaction and psychological well-being (in terms of anxiety/depression) * Evaluate the homogeneity of the impact of the intervention according to covariates (gender, tumor pathology, occupational status, and center) * Evaluate the reasons for recruitment failures

Вмешательства

• Другое Oncological Follow-up
  Post-cancer surveillance (including biological, clinical and imaging exams depending on the condition)

Первичные конечные точки

• 2-year compliance to the customized surveillance plan [Срок оценки: 2 years]

Вторичные конечные точки (7)

• 5-year compliance to the customized surveillance plan [Срок оценки: 5 years]
• Drop-out rate [Срок оценки: 5 years]
• Description of the use of care [Срок оценки: 5 years]
• Occurrence and management of oncological events [Срок оценки: 5 years]
• Progression-free survival [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]
• Support care needs identified [Срок оценки: 2 years (early termination in case of relapse of the disease)]

Критерии участия

Критерии включения

• Positive diagnosis (anatomopathology) of tumor within 12 months
• Patient 18 years of age or older
• Patient with one of the following conditions:

• Desmoid fibromatosis of the abdominal wall operated on or under active surveillance
• Stage I testicular seminoma (whether or not treated with carboplatin AUC7)
• Stage I non-seminomatous germ cell tumor (with or without adjuvant BEP chemotherapy)
• Operated GIST with low risk of relapse
• Rare gynecological tumors (sex cord and stromal tumors; germ cell tumors of the ovary, clear cell adenocarcinoma, mucinous adenocarcinoma of the ovary, borderline tumors, small cell carcinoma, ovarian and uterine carcinosarcoma, low grade serous tumors), operated
• Low-grade glioma, operated
• Low-grade neuroendocrine tumor, treated by surgery alone
• Patient who has given consent to participate in the study

Критерии исключения

• Contraindication to imaging tests required for the surveillance plan
• No telephone
• Patient under guardianship or curatorship

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

Организация здравоохранения

Центры проведения

Франция · 3 центра

• CHU Amiens — Amiens
• Centre François Baclesse — Caen
• Centre Oscar Lambret — Lille

Публикации

• Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174. PMID 20429948
• Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7. PMID 31280494
• Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018. PMID 30093916
• Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20. PMID 34922758
• Ferrua M, Minvielle E, Fourcade A, Lalloue B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4. PMID 32429987

Идентификаторы

NCT: NCT05500391 · SUR-CAN-2201 · 2022-A01482-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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