The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life
GLINK
1 other identifier
interventional
244
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2027
August 8, 2025
July 1, 2025
1.6 years
June 25, 2025
July 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health Related Quality of Life
Summary score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This questionnaire consists of five functioning scales (physical, emotional, role, cognitive and social functioning), three symptom scales (fatigue, nausea \& vomiting) and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-C30 summary score ranges from 0 to 100, with higher scores indicating better health-related quality of life. This summary score is calculated as the mean of all scale scores (excluding global QoL and financial difficulties).
Measured at 0, 6 and 12 months
Secondary Outcomes (18)
Health-Related Quality of Life - separate functioning and symptom scales
Measured at 0, 6 and 12 months
Cancer-related fatigue
Measured at 0, 6 and 12 months
Sleep Hygiene
Measured at 0, 6 and 12 months
Positive Health
Measured at 0, 6 and 12 months
Height
Measured at 0 and 6 months
- +13 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALFollowing a combined lifestyle intervention for 12 months
Control group
PLACEBO COMPARATORReceiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.
Interventions
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.
The control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Tilburg Universitycollaborator
- VU University of Amsterdamcollaborator
- Ede Christian University of Applied Sciencescollaborator
Study Sites (1)
UMC Utrecht
Utrecht, Netherlands
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kristel van Asselt, PhD, MD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Epidemiologist and general practitioner
Study Record Dates
First Submitted
June 25, 2025
First Posted
August 8, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 15, 2027
Last Updated
August 8, 2025
Record last verified: 2025-07