Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tilburg University | OTHER |
| VU University of Amsterdam | OTHER |
| Ede Christian University of Applied Sciences | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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. Participants will be either within five years post-primary treatment OR have advanced cancer (stage IV) with a prolonged life expectancy. Patients in the intervention arm will be offered a combined lifestyle intervention guided by a lifestyle coach or oncology physiotherapist 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. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Following a combined lifestyle intervention for 12 months |
|
| Control group | Placebo Comparator | Receiving four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined lifestyle intervention focusing on various lifestyle components, delivered by a lifestyle coach and oncology nurse | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Manshanden, MSc | Contact | +31615252647 | a.manshanden@vu.nl | |
| Evelyn Monninkhof, PhD | Contact | +31623786177 | e.monninkhof@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Kristel van Asselt, PhD, MD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Recruiting | Utrecht | Utrecht | Netherlands |
Not provided
| Label | URL |
|---|---|
| General website of the study where participants can find information and apply for the study.. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| short online lifestyle intervention by lifestyle coach and educational materials after 6 months | Behavioral | The control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention |
|
| 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 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 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 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 at 0 and 6 months |
| Weight | Weight (in kilograms) measured in light clothing without shoes using standardized procedures described in study SOPS | 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 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 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 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 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 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 at 0, 6 and 12 months |
| Smoking status | Smoking status (yes/no) will be assessed with a self-developed questionnaire. | 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 at 0, 6 and 12 months |
| Health care costs | Assessed by a modified version of the iMTA Medical Cost Questionnaire (iMCQ) | Measured at 0, 6 and 12 months |
| Costs of Productivity loss | Assesed by the Productivity Cost Questionnaire (iPCQ) | Measured at 0, 6 and 12 months |
| Costs of informal care | Assessed by the iMTA Valuation of Informal Care Questionnaire (iVCQ) | Measured at 0, 6 and 12 months |
| Health literacy | General health literacy will be measured with the Dutch Short Health Literacy Scale (HLS-EU-Q16). This questionnaire consists of three subscales: health care, disease prevention and health promotion. The B1-level translated Dutch version will be used. It consists of 16 items, each rated on a 4-point Likert scale ranging from 1 (very difficult) to 4 (very easy). Responses are dichotomized (1-2 = 0, 3-4 = 1) and summed into a total score ranging from 0 to 16, with higher scores indicating higher perceived health literacy. | Measured at 0, 6 and 12 months |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided