Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

Обзор

The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up. Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.

Подробное описание

This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption.

All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years.

By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.

Вмешательства

• Другое Weekly symptom monitoring
  Patients randomized to the intervention arm will be invited to respond to a web-based weekly 11-item signs- and symptoms questionnaire

Первичные конечные точки

• Overall survival [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 60 months.]

Вторичные конечные точки (6)

• Progression free survival [Срок оценки: From date of randomization until the date of first confirmed disease progression as judged by the investigator, assessed up to 24 months.]
• Performance status [Срок оценки: At baseline and at each clinical visit (approximately every 3-4 months), assessed up to 24 months.]
• Proportion of patients starting second-line anti-neoplastic treatment [Срок оценки: Assessed up to 24 months.]
• Quality of life [Срок оценки: At baseline and every three months, assessed up to 24 months.]
• Symptoms of depression [Срок оценки: At baseline and every three months, assessed up to 24 months.]
• Number of days of in-hospital care [Срок оценки: Assessed up to 24 months.]

Критерии участия

Критерии включения

• Histologically or cytology proven non-small cell lung cancer (NSCLC)
• NSCLC stage III or IV
• ≥ 18 years
• ECOG performance status 0- 2
• Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment
• Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment
• Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis)
• Initial web-based application score of ≤ 6
• Basic computer literacy
• Bank-ID (electronic identification system) and access to "1177 Vårdguiden"
• The subject has given written consent to participate in the study

Критерии исключения

• Symptomatic brain metastases
• Pregnancy, breastfeeding, or planned pregnancy
• Persons under guardianship or deprived of liberty
• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
• Treatment or disease which, according to the investigator, can affect treatment or study results
• Ongoing participation in another interventional clinical study

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085. PMID 30667494
• Temel JS, Greer JA, El-Jawahri A, Pirl WF, Park ER, Jackson VA, Back AL, Kamdar M, Jacobsen J, Chittenden EH, Rinaldi SP, Gallagher ER, Eusebio JR, Li Z, Muzikansky A, Ryan DP. Effects of Early Integrated Palliative Care in Patients With Lung and GI Cancer: A Randomized Clinical Trial. J Clin Oncol. 2017 Mar 10;35(8):834-841. doi: 10.1200/JCO.2016.70.5046. Epub 2016 Dec 28. PMID 28029308
• Nilsson J, Berglund A, Bergstrom S, Bergqvist M, Lambe M. The role of comorbidity in the management and prognosis in nonsmall cell lung cancer: a population-based study. Acta Oncol. 2017 Jul;56(7):949-956. doi: 10.1080/0284186X.2017.1324213. Epub 2017 May 9. PMID 28486004
• Nipp R, Temel J. The Patient Knows Best: Incorporating Patient-Reported Outcomes Into Routine Clinical Care. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx044. No abstract available. PMID 28423408
• Basch E, Snyder C. Overcoming barriers to integrating patient-reported outcomes in clinical practice and electronic health records. Ann Oncol. 2017 Oct 1;28(10):2332-2333. doi: 10.1093/annonc/mdx506. No abstract available. PMID 28961852

Идентификаторы

NCT: NCT05621902 · 102877

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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