Clinical Trials Directory

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RecruitingNCT07110753

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
244 (estimated)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALcombined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurseThe 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.
BEHAVIORALshort online lifestyle intervention by lifestyle coach and educational materials after 6 monthsThe control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention

Timeline

Start date
2025-08-01
Primary completion
2027-03-01
Completion
2027-04-15
First posted
2025-08-08
Last updated
2025-08-08

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07110753. Inclusion in this directory is not an endorsement.