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临床试验/NCT06381024
NCT06381024已完成不适用

A Study of the Benefit of Telemonitoring for Hospital Staff Treating Patients With Oral or Intravenous Cancer Treatments: a French Prospective, Randomized, Unblinded, Single-centre Study.

Centre Hospitalier de Bligny1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment

研究概览

简要总结

The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

  • In-person care alone (Standard of care group).
  • In-person care with Cureety telemonitoring (Standard of care with Cureety group).

Participants will:

  • be monitored with digital application Cureety (Standard of care with Cureety group)
  • fill out quality of life questionnaire (baseline, 2 months, 4 months)
  • fill out satisfaction questionnaire (2 months, 4 months)
  • have the ongoing and incoming phone calls logged (duration and type)

详细描述

Rationale:

Telemonitoring of cancer patients provides patients with cancer-related information, as well as allowing appointment management, early detection of side-effects/adverse events (AEs), and the collection of safety and quality of life data from the patients' perspectives.1 Several studies have assessed the benefit of telemonitoring from the patients' perspective.1-5 However, few studies have investigated the benefit of telemonitoring for healthcare professionals.4,6,7 The Symptom Tracking and Reporting (STAR) randomized trial, performed at the Memorial Sloan Kettering Institute, randomly allocated patients to either usual care or the patient-reported outcome (PRO) group.8,9 Patients in the PRO group completed a web-based questionnaire concerning 12 common AEs (based on the National Cancer Institute Common Terminology Criteria for AEs [NCI-CTCAE version (v) 5.0]10) at or between visits. In the PRO group, 63% of patients reported severe AEs during the study. Patients, in the PRO group, reported improved quality of life, fewer admissions to emergency rooms or hospitalization, extended duration of chemotherapy, and extended overall survival (OS). This increased OS is potentially due to the early response by healthcare professionals to severe AEs identified by the web-based questionnaire. For healthcare professionals, the study reported fewer unscheduled visits for patients allocated to the PRO group.

Interestingly, in the STAR trial, 77% of the nurse interventions (either by email or telephone) were in response to alerts (either counseling or symptom management), 12% were for initiating or changing of supportive treatment, 8% were for referrals to the emergency room or hospital, 2% were for chemotherapy dose modifications, and 2% were for ordering imagery or biological test.11 In France, the Foch hospital initiated the Star program for patients undergoing chemotherapy.12 The program collects patient data within at most 3 days prior to each chemotherapy session and transfer these to healthcare professionals to prepare the chemotherapy. The patient has the choice of completing a questionnaire via the internet or providing the information by telephone with the aid of a nurse. The data includes health status, presence of AEs, and blood test results. These data allow healthcare professionals to adapt or delay the chemotherapy, change treatments, and provide the patient with personalized advice according to the patient's health status. The program has improved the performance of departments involved by increasing the number of patients treated per day, decreasing the waiting times for patients, and by reducing the wastage of healthcare products.

Consequently, numerous French healthcare centers want to implement programs like the Star program. However, a substantial portion of the data collection occurs via the telephone, particularly outgoing calls (from the hospital staff to patients). This increase in telephone communication means more work for healthcare professions. A digital telemonitoring platform, like Cureety that can collect this data before chemotherapy, is expected to decrease outgoing calls by between 30% to 50% and facilitate the implementing of these programs.

Furthermore, healthcare centers in France are continually facing budget restrictions. At the same time, treating cancer patients is associated with an increase in incoming calls from patients during cancer treatment, particularly for minor AEs. The treating of these incoming calls is often repetitive and time consuming for hospital staff. The collection of data concerning AEs, of varying severity, can be integrated in a digital platform. Patients with minor AEs can be provided with the actions to be followed via the platform. This will allow staff to concentrate on patients with severe AEs needing urgent attention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that have provide written informed consent for study participation.
  • Patients aged 18 years or older.
  • Patients initiating oral or intravenous treatment (chemotherapy, immunotherapy, targeted therapies etc.) for localized or metastatic or recurrent cancer treated at the CH Bligny.
  • Patients with the capacity, personally (e.g., language and capacity to use the application), and in terms of infrastructure (internet access, possessing a smart phone etc.) to perform telemonitoring with Cureety.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

排除标准

  • Patients treated for cancer at the CH Bligny in the last 5 years

结局指标

主要结局

Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment

时间窗: 4 months after randomization

Number of calls, defined as the number of incoming and outgoing calls that occurs during the 4 months from randomization

次要结局

  • Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment(During 4 months after randomization)
  • Hospital-free survival rate(During 4 months after randomization)
  • Quality of life at 2 and 4 months after initiation of cancer treatment.(During 4 months after randomization)
  • Numbers of telephone calls during the first 4 months of cancer treatment in subgroups(During 4 months after randomization)
  • Patient satisfaction with the healthcare provided(During 4 months after randomization)
  • CH Bligny staff satisfaction with the healthcare provided(At 12 months after first inclusion)

研究者

发起方
Centre Hospitalier de Bligny
申办方类型
Other
责任方
Sponsor

研究点 (1)

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