Combined lifestyle program to improve quality of life for people with cancer
The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study
This program tests whether a coached, multi-component lifestyle intervention (diet, activity, and support) with a 6-month intensive phase plus 6-month maintenance can improve quality of life for adults with cancer who still have symptoms after treatment or have long-term advanced disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT07110753 on ClinicalTrials.gov |
What this trial studies
GLINK is a pragmatic randomized controlled trial that will enroll 244 adults with cancer and reduced health-related quality of life and randomize them 1:1 to a combined lifestyle intervention or a control condition. The intervention arm receives a lifestyle program led by a lifestyle coach, oncology physiotherapist, and oncology nurse, consisting of a 6-month intensive phase followed by a 6-month maintenance phase. The control group receives four online group sessions and access to educational materials after the first 6 months. The primary outcome is quality of life, with secondary outcomes including Positive Health, lifestyle behaviors, and anthropometric measures.
Who should consider this trial
Good fit: Adults aged 40 or older with invasive or hematological cancer who report reduced HRQoL and are either within five years after primary curative-intent treatment or have advanced (stage IV) cancer with prolonged life expectancy, and who can speak Dutch, are ideal candidates.
Not a fit: Younger patients under 40, people without reduced quality of life, those unable to participate in Dutch-language sessions or attend the UMC Utrecht program, or patients with very limited life expectancy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve quality of life, reduce fatigue, and help patients adopt healthier, sustainable habits after cancer treatment.
How similar studies have performed: Previous randomized trials of multi-component lifestyle programs for cancer survivors have shown modest to moderate improvements in quality of life and fatigue, but results are variable and large pragmatic trials are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Kristel van Asselt, PhD, MD — UMC Utrecht
- Study coordinator: Anna Manshanden, MSc
- Email: a.manshanden@vu.nl
- Phone: +31615252647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.