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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Netherlands1 site
  • UMC Utrecht

    Utrecht, Utrecht

Other trials in Netherlands

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 groups in NCT07110753
Study groupRoleWhat they receive
Intervention groupExperimentalFollowing 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 groupPlacebo comparatorReceiving 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.

  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: Measured at 0, 6 and 12 months

Secondary outcomes (19)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Weight

    Weight (in kilograms) measured in light clothing without shoes using standardized procedures described in study SOPS

    Measured: Measured at 0 and 6 months

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. Smoking status

    Smoking status (yes/no) will be assessed with a self-developed questionnaire.

    Measured: Measured at 0, 6 and 12 months

  14. 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

  15. Health care costs

    Assessed by a modified version of the iMTA Medical Cost Questionnaire (iMCQ)

    Measured: Measured at 0, 6 and 12 months

  16. Costs of Productivity loss

    Assesed by the Productivity Cost Questionnaire (iPCQ)

    Measured: Measured at 0, 6 and 12 months

  17. Costs of informal care

    Assessed by the iMTA Valuation of Informal Care Questionnaire (iVCQ)

    Measured: Measured at 0, 6 and 12 months

  18. Health literacy general

    General health literacy will be measured with the HLS19Q12.

    Measured: Measured at 0, 6 and 12 months

  19. 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.

  1. First posted8 Aug 2025
  2. Study start15 Sep 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

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)
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.

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.

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