CancerGLINKNCT07110753
The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life
A study testing combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse and short online lifestyle intervention by lifestyle coach and educational materials after 6 months in people with Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse and short online lifestyle intervention by lifestyle coach and educational materials after 6 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with an invasive or haematological malignancy and either within five years after completion of primary treatment with curative intent, or having metastatic / chronic cancer with a prolonged life expectancy. 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study
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.
Read the 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. Patients are diagnosed with an invasive or haematological malignancy and either within five years after completion of primary treatment with curative intent, or having metastatic / chronic cancer with a prolonged life expectancy.
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 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 at 6 months. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.
- Conditions
- Cancer
- Being tested
- combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse, short online lifestyle intervention by lifestyle coach and educational materials after 6 months
- Keywords
- cancer, combined lifestyle intervention, quality of life, positive health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurseBehavioural
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.
short online lifestyle intervention by lifestyle coach and educational materials after 6 monthsBehavioural
The control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Following a combined lifestyle intervention for 12 months Receives: Behavioral: combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse |
| Control group | Placebo comparator | Receiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months. Receives: Behavioral: short online lifestyle intervention by lifestyle coach and educational materials after 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 0, 6 and 12 months
Secondary outcomes (19)
Health-Related Quality of Life - separate functioning and symptom scales
Separate functioning and symptom scales 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 pain) and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scale and item scores range from 0 to 100. Higher scores on the summary score and function scales indicate a better quality of life. Higher scores on the symptom scales mean more symptoms.
Measured: Measured at 0, 6 and 12 months
Cancer-related fatigue
Assessed with the Multidimensional Fatigue Inventory (MFI). The MFI is a 20-item questionnaire assessing five dimensions of fatigue: general, physical and mental fatigue, reduced activity, and reduced motivation. Each dimension has 4 items, and each item is scored on a 5-point Likert scale (1 to 5).The resulting scale scores for each dimension range from 4 to 20. Higher scores indicate higher levels of fatigue.
Measured: Measured at 0, 6 and 12 months
Sleep Hygiene
Assessed with the Sleep Hygiene Index (SHI). The SHI is a questionnaire consisting of 12 items that assess sleep-related behaviors. The total score is the sum of all item responses, ranging from 0 to 52, with higher scores indicating worse sleep hygiene.
Measured: Measured at 0, 6 and 12 months
Positive Health
Assessed with the 17-item Positive Health measurement tool, based on the Positive Health dialogue tool, which is widely used in the Netherlands. This tool measures six factors: physical fitness, mental functions, future perspectives, contentment, social relations, and health management. Items are scored on an 11-point scale ranging from 0 (totally disagree) to 10 (totally agree). For each factor, an average score can be calculated, with higher scores indicating better perceived Positive Health within that factor.
Measured: Measured at 0, 6 and 12 months
Height
Height (in centimeters) will be measured in light clothing without shoes using standardized procedures described in study SOPs.
Measured: Measured at 0 and 6 months
Weight
Weight (in kilograms) measured in light clothing without shoes using standardized procedures described in study SOPS
Measured: Measured at 0 and 6 months
Waist circumference
Waist circumference (in centimeters) will be measured in light clothing without shoes using standardized procedures described in study SOPs.
Measured: Measured at 0 and 6 months
Body composition
To assess body composition (fat mass and fat free mass), a whole body bio impedance analysis will be performed at baseline and 6 months follow-up. Patients are measured in a lying position. Raw (i.e., reactance, resistance, and phase angle) or summary (fat (free) mass in kg) bioimpedance data are registered and for raw data estimates fat mass and fat-free mass are obtained using the Kyle equation.
Measured: Measured at 0 and 6 months
Physical activity - questionnaire
Assessed by the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). This questionnaire contains questions on commuting activities, leisure-time and sports activities, household activities, and activities at work. For each activity, participants report the number of days per week, the average duration per day (in minutes), and the perceived intensity (light, moderate, or vigorous). The outcomes are expressed in minutes of physical activity per week. Higher scores indicate a higher level of physical activity.
Measured: Measured at 0, 6 and 12 months
Physical activity - tracker
Assessed by the ActivPAL activity tracker (PAL technologies). The is small device, which has shown to reliable measure and distinguish between sitting time, standing time and stepping time.
Measured: Measured at 0 and 6 months. The device will be worn for nine consecutive days, on the right mid-thigh, attached with adhesive tape.
Diet components
Dietary related to cancer risk will be assessed: intake of fruit and vegetables, red and processed meat, and alcohol. These will be measured using items adapted from the Gezondheidsenquête CBS 2023 questionnaire, which is based on the Richtlijnen Goede Voeding 2015. Additionally, the use of nutritional supplements will be assessed.
Measured: Measured at 0, 6 and 12 months
Pack years of smoking
Pack years (smoking duration * amount of cigartettes) will be assessed with a self-developed questionnaire.
Measured: Measured at 0, 6 and 12 months
Smoking status
Smoking status (yes/no) will be assessed with a self-developed questionnaire.
Measured: Measured at 0, 6 and 12 months
Cost-effectiveness - EuroQol(EQ)-5D-5L
The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) is used to measure health in five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, using 5 levels of severity. The patients' EQ-5D-5L health states are converted into utility values using the Dutch tariff, after which they are used to calculate quality adjusted life years (QALYs).
Measured: Measured at 0, 6 and 12 months
Health care costs
Assessed by a modified version of the iMTA Medical Cost Questionnaire (iMCQ)
Measured: Measured at 0, 6 and 12 months
Costs of Productivity loss
Assesed by the Productivity Cost Questionnaire (iPCQ)
Measured: Measured at 0, 6 and 12 months
Costs of informal care
Assessed by the iMTA Valuation of Informal Care Questionnaire (iVCQ)
Measured: Measured at 0, 6 and 12 months
Health literacy general
General health literacy will be measured with the HLS19Q12.
Measured: Measured at 0, 6 and 12 months
Helath Health literacy - reading and numeric skills
Health literacy - reading and numeric skills - will be measured with the Newest Vital Sign Dutch (NVSD).This six-item tool assesses the ability to obtain, interpret, and apply textual and numerical information presented on a nutrition label.
Measured: Measured at 0 months (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, VU University of Amsterdam, Ede Christian University of Applied Sciences
- Responsible party
- Principal investigator, Kristel van Asselt, UMC Utrecht
- Investigators
- Kristel van Asselt, PhD, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110753
- Sponsor's protocol ID
- NL-009215
- Acronym
- GLINK
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The possibility of sharing individual participant data (IPD) will be determined at a later stage, taking into account applicable privacy regulations, ethical guidelines, and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study
- ClinicalTrials.gov ID
- NCT07110753
- Acronym / sponsor ID
- GLINK / NL-009215
- Conditions
- Cancer
- Keywords
- cancer, combined lifestyle intervention, quality of life, positive health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 221 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Tilburg University, VU University of Amsterdam, Ede Christian University of Applied Sciences
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Patients are diagnosed with an invasive or haematological malignancy and either within five years after completion of primary treatment with curative intent, or having metastatic / chronic cancer with a prolonged life expectancy.
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 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 at 6 months. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurseFollowing a combined lifestyle intervention for 12 months |
| Control group | Placebo comparator | Behavioral: short online lifestyle intervention by lifestyle coach and educational materials after 6 monthsReceiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be diagnosed with an invasive or haematological malignancy and either within five years after completion of primary treatment with curative intent, or having metastatic / chronic cancer with a prolonged life expectancy. 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined 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. | Behavioural | Intervention group |
| short 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 | Behavioural | Control group |
Primary outcome
Health Related Quality of Life
Time frame: Measured at 0, 6 and 12 months
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).
19 secondary outcomes
Health-Related Quality of Life - separate functioning and symptom scales
Time frame: Measured at 0, 6 and 12 months
Cancer-related fatigue
Time frame: Measured at 0, 6 and 12 months
Sleep Hygiene
Time frame: Measured at 0, 6 and 12 months
Positive Health
Time frame: Measured at 0, 6 and 12 months
Height
Time frame: Measured at 0 and 6 months
Weight
Time frame: Measured at 0 and 6 months
Waist circumference
Time frame: Measured at 0 and 6 months
Body composition
Time frame: Measured at 0 and 6 months
Physical activity - questionnaire
Time frame: Measured at 0, 6 and 12 months
Physical activity - tracker
Time frame: Measured at 0 and 6 months. The device will be worn for nine consecutive days, on the right mid-thigh, attached with adhesive tape.
Diet components
Time frame: Measured at 0, 6 and 12 months
Pack years of smoking
Time frame: Measured at 0, 6 and 12 months
Smoking status
Time frame: Measured at 0, 6 and 12 months
Cost-effectiveness - EuroQol(EQ)-5D-5L
Time frame: Measured at 0, 6 and 12 months
Health care costs
Time frame: Measured at 0, 6 and 12 months
Costs of Productivity loss
Time frame: Measured at 0, 6 and 12 months
Costs of informal care
Time frame: Measured at 0, 6 and 12 months
Health literacy general
Time frame: Measured at 0, 6 and 12 months
Helath Health literacy - reading and numeric skills
Time frame: Measured at 0 months (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- General website of the study where participants can find information and apply for the study..Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The possibility of sharing individual participant data (IPD) will be determined at a later stage, taking into account applicable privacy regulations, ethical guidelines, and participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristel van Asselt, PhD, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse and short online lifestyle intervention by lifestyle coach and educational materials after 6 months in people with Cancer, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: Measured at 0, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.