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Combined Lifestyle Intervention for cancer patients

The effect of a combined lifestyle intervention for patients with cancer on quality of life: the randomized GLINK study - GLINK

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57521
Enrollment
244
Registered
2025-02-04
Start date
2025-09-15
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Carcinoma, malignancies

Interventions

Patients in the intervention arm will be offered a combined lifestyle intervention guided by a lifestyle coach and oncology nurse. The intervention consists of an intensive intervention phase of 6 mon
Group sessions take place near the home of the patients.&nbsp
The control patients will receive four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a participant must:Be diagnosed with an invasive or haematological cancer type Be 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 stem cell transplant in case of haematological 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.  Be 40 years of age or older. Be able to speak and understand Dutch    

Exclusion criteria

Exclusion criteria: A participant who meets any of the following criteria will be excluded from participation in this study:o Following, or planning to follow a combined lifestyle intervention (i.e., one of the existing interventions for overweight) during the intervention periodo Patients in the terminal phase (life expectancy < 3 months)o 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 teamo Any circumstances that would impede the ability to give informed consent or adherence to study requirements as determined by the study team or treating physician  

Design outcomes

Primary

MeasureTime frame
The primary endpoint is HRQoL measured with the EORTC QLQ-C30 summary score at 6 months after baseline.

Secondary

MeasureTime frame
Secondary outcomes:Function and symptom scales of Health-related Quality of Life (EORTC-QLQ-C30)Cancer-related fatiguePositive Health (Positive Health measurement model)Sleep hygiene (SHI)Physical Activity (SQUASH & ActivPAL)Diet components: fruit and vegetables, red and processed meat, alcohol, and nutritional supplementsSmoking status (yes/no) and packyearsAnthropometrics (height, weight, waist, body composition)Cost-effectiveness (EQ-5D-5L, societal and healthcare costs)Safety: (serious) adverse events 

Countries

Netherlands

Contacts

Public ContactEM Monninkhof

Universitair Medisch Centrum Utrecht

glinkstudie@umcutrecht.nl088-7568181

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 19, 2026