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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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.
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (12)

• Health-Related Quality of Life - separate functioning and symptom scales [Time frame: Measured at 0, 6 and 12 months]
• Cancer-related fatigue [Time frame: Measured at 0, 6 and 12 months]
• Sleep Hygiene [Time frame: Measured at 0, 6 and 12 months]
• Positive Health [Time frame: Measured at 0, 6 and 12 months]
• Height [Time frame: Measured at 0 and 6 months]
• Weight [Time frame: Measured at 0 and 6 months]
• Waist circumference [Time frame: Measured at 0 and 6 months]
• Body composition [Time frame: Measured at 0 and 6 months]
• Physical activity - questionnaire [Time frame: Measured at 0, 6 and 12 months]
• Physical activity - tracker [Time frame: 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 [Time frame: Measured at 0, 6 and 12 months]
• Pack years of smoking [Time frame: Measured at 0, 6 and 12 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Netherlands · 1 center

• UMC Utrecht — Utrecht

Identifiers

NCT: NCT07110753 · NL-009215

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗