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

UMC Utrecht

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse; Behavioral: short online lifestyle intervention by lifestyle coach and educational materials after 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT07110753

NL-009215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Following a combined lifestyle intervention for 12 months

Treatment:

Behavioral: combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse

Control group

Placebo Comparator group

Description:

Receiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.

Treatment:

Behavioral: short online lifestyle intervention by lifestyle coach and educational materials after 6 months