The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life

Официальное название

The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study

Обзор

A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. This study aims to assess the effect of a combined lifestyle intervention for patients with cancer on quality of life.

Подробное описание

A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. The aim of this study is to assess the effect of a combined lifestyle intervention for patients with cancer, who suffer from the consequences of cancer and its treatment, on quality of life.

The GLINK study is a pragmatic randomized controlled trial with two study arms: an intervention (n=122)- and a control arm (n=122).

The investigators will recruit 244 cancer patients who have a reduced quality of life. Participants will be either within five years post-primary treatment OR have advanced cancer (stage IV) with a prolonged life expectancy. Patients in the intervention arm will be offered a combined lifestyle intervention guided by a lifestyle coach or oncology physiotherapist and oncology nurse. The intervention consists of an intensive intervention phase of 6 months and a maintenance phase of another 6 months. The control patients will receive four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.

The primary endpoint is quality of life. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.

Вмешательства

• Поведенческое combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse
  The combined lifestyle intervention focuses on various lifestyle components, including nutrition, physical activity, sleep, stress and sense of purpose, and is structured around the process of behaviour change. It is delivered by a lifestyle coach in collaboration with an oncology nurse.
• Поведенческое short online lifestyle intervention by lifestyle coach and educational materials after 6 months
  The control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention

Первичные конечные точки

• Health Related Quality of Life [Срок оценки: Measured at 0, 6 and 12 months]

Вторичные конечные точки (12)

• Health-Related Quality of Life - separate functioning and symptom scales [Срок оценки: Measured at 0, 6 and 12 months]
• Cancer-related fatigue [Срок оценки: Measured at 0, 6 and 12 months]
• Sleep Hygiene [Срок оценки: Measured at 0, 6 and 12 months]
• Positive Health [Срок оценки: Measured at 0, 6 and 12 months]
• Height [Срок оценки: Measured at 0 and 6 months]
• Weight [Срок оценки: Measured at 0 and 6 months]
• Waist circumference [Срок оценки: Measured at 0 and 6 months]
• Body composition [Срок оценки: Measured at 0 and 6 months]
• Physical activity - questionnaire [Срок оценки: Measured at 0, 6 and 12 months]
• Physical activity - tracker [Срок оценки: Measured at 0 and 6 months. The device will be worn for nine consecutive days, on the right mid-thigh, attached with adhesive tape.]
• Diet components [Срок оценки: Measured at 0, 6 and 12 months]
• Pack years of smoking [Срок оценки: Measured at 0, 6 and 12 months]

Критерии участия

Критерии включения

• Be diagnosed with an invasive or hematological cancer type and either within five years post-primary treatment with curative intent OR having advanced cancer (stage IV) with a prolonged life expectancy (chronic cancer patients) . Primary treatment in this context, includes among others surgery (> 3 months ago), radiotherapy, and/or chemotherapy or a stem cell transplant in case of hematological cancers.
• Report a reduced HRQoL, i.e., a low score on at least 2 of the functioning scales and/or the symptom scale fatigue of the EORTC-QLQ-30 based on the thresholds of clinical importance of Giesinger et al. (2020)
• Be 40 years of age or older. The investigators have chosen this cut-off because they believe that younger cancer patients (AYA's) face different challenges and should not be mixed with the average older patient. This approach ensures greater homogeneity within the study population.
• Be able to speak and understand Dutch

Критерии исключения

• Following, or planned to follow a combined lifestyle intervention (i.e., one of the existing interventions for overweight) during the intervention period
• Patients in the terminal phase (life expectancy < 3 months)
• Mental or behavioural problems that hinder participating in group lifestyle coaching indicated by the health care professional who is referring to GLINK or by the study team
• Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team or treating physician

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

Нидерланды · 1 центр

• UMC Utrecht — Utrecht

Идентификаторы

NCT: NCT07110753 · NL-009215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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