MultimorbidityLifeMedsNCT07846800
The LifeMeds Cohort
An observational study of Multimorbidity and Cancer, run by Tilburg University.
Trial summary
The goal of this observational study is to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in adults with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases, including cardiovascular disease, type 2 diabetes, chronic respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity, Cancer, Cardio Vascular Disease
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory disease and/or cancer. To ensure sufficient homogeneity for analysing combinations of multimorbidity while still capturing clinically relevant variation, the study focuses on the most common subtypes of these conditions with aetiologies strongly linked to lifestyle. For cancer, this includes breast , colorectal, prostate and lung cancer. For cardiovascular disease subtypes include coronary artery disease, heart failure, peripheral artery disease and hypertension. Chronic respiratory disease subtypes include chronic obstructive pulmonary disease and asthma. Finally, all clinically confirmed cases of type 2 diabetes mellitus are eligible. Individuals with a history of any of these conditions are eligible, allowing the cohort to capture the full spectrum of disease progression, remission and relapse.
Who may be able to join
- Diagnosed with two or more of the following diseases: type 2 diabetes, cancer, cardiovascular disease and/or chronic respiratory diseases.
- Aged 18 years or older
Who cannot join
- Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The LifeMeds Cohort: Joining Forces to Assess (Determinants of) Lifestyle Behavior, Morbidity and Mortality Among Multimorbid Individuals
The goal of this observational study is to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in adults with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases, including cardiovascular disease, type 2 diabetes, chronic respiratory disease, and/or cancer. The main questions it aims to answer are:
- What lifestyle trajectories can be identified over time in individuals with multimorbidity, how do these trajectories differ across multimorbidity profiles, and which psychological, social, and sociodemographic factors are associated with these trajectories?
- How are lifestyle trajectories associated with morbidity, mortality, health-related quality of life, and other major health outcomes over time?
Participants will complete one annual questionnaire during a follow-up period of ten years.
Read the detailed description
Background and Rationale:
Multimorbidity, commonly defined as the coexistence of two or more chronic diseases, is an increasing public health challenge associated with reduced quality of life, increased healthcare utilization, and premature mortality. Lifestyle behaviours, including physical activity, diet, smoking, alcohol consumption, sleep, and medication adherence, play an important role in the prevention and management of many chronic diseases. Although lifestyle interventions have been developed and evaluated for individual chronic diseases, considerably less is known about lifestyle behaviour patterns, their determinants, and effective lifestyle support strategies among individuals living with multimorbidity. The coexistence of multiple chronic conditions may introduce unique barriers and facilitators to lifestyle modification that are not adequately captured in single-disease research. Therefore, the LifeMeds cohort was established to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in individuals with multimorbidity over time.
Aims and Objectives:
Aim 1: To longitudinally identify lifestyle behaviours and their determinants in individuals with multimorbidity.
- Objective 1a. To investigate lifestyle trajectories of individuals with multimorbidity and to identify potential similarities and differences in lifestyle trajectories between individuals with different combinations of multimorbidity.
- Objective 1b. To identify determinants of lifestyle behaviours in individuals with multimorbidity and monitor changes over time.
- Objective 1c. To link different lifestyle trajectories to future morbidity and mortality risk.
Aim 2: To investigate the impact of multimorbidity on health outcomes and to identify the determinants associated with these outcomes.
- Objective 2a. To assess quality of life, morbidity, and mortality risk among individuals with different combinations of multimorbidity.
- Objective 2b. To identify the clinical, sociodemographic, medical, social, and psychological determinants associated with morbidity and mortality incidence in individuals with different combinations of multimorbidity.
Study Population:
Eligible participants are adults aged 18 years and older with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases. To capture the full spectrum of disease burden, disease progression, and risk of recurrence, individuals with either a current or previous diagnosis of an eligible condition will be considered for inclusion. The LifeMeds cohort focuses on chronic diseases with a strong association with lifestyle-related risk factors, including type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), chronic respiratory disease (CRD), and cancer. All cases of T2DM will be eligible for inclusion, whereas for the remaining disease groups the study will focus on the most prevalent lifestyle-related subtypes. Eligible cancer diagnoses comprise breast, colorectal, prostate, and lung/bronchus cancer. Eligible cardiovascular diseases comprise coronary artery disease, heart failure, peripheral artery disease, and hypertension, while eligible chronic respiratory diseases comprise chronic obstructive pulmonary disease (COPD) and asthma.
Study Design and Recruitment:
The LifeMeds cohort is a prospective longitudinal observational study with a planned follow-up period of 10 years. Participants will be recruited through participating hospitals and community-based recruitment strategies. In participating hospitals, eligible individuals may be informed about the study by their treating healthcare professional during routine care encounters. In addition, participants may self-register through online advertisements distributed via patient organizations and social media platforms, or through flyers distributed in community settings such as supermarkets, community centres, and pharmacies.
Individuals who meet the eligibility criteria and provide informed consent will be enrolled in the cohort. Participants will complete a baseline questionnaire followed by annual follow-up questionnaires throughout the 10-year study period.
- Conditions
- Multimorbidity, Cancer, Cardio Vascular Disease, Chronic Respiratory Conditions, Type 2 Diabetes
- Keywords
- Multimorbidity, Lifestyle Behavior, Determinants, Health Outcomes, Mortality, Quality of Life, Longitudinal cohort
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multimorbid individuals | Individuals who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory diseases and/or cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).
The SQUASH is a validated questionnaire that assesses habitual physical activity across commuting, household, leisure-time, and occupational domains. Repeated assessments over time will enable the evaluation of changes in physical activity levels.
Measured: From enrollment to the end of the study at 10 years
Changes in dietary intake using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI).
Dietary intake is assessed using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI). The questionnaire captures key aspects of diet quality and adherence to dietary recommendations. Repeated assessments over time will enable the evaluation of changes in dietary behaviours.
Measured: From enrollment to the end of the study at 10 years
Changes in alcohol consumption using a self-composed questionnaire.
Participants will first be asked whether they consume alcohol. Those who do will be asked to report their average weekly intake, specified in number of glasses, across four predefined categories of alcoholic beverages: beer, craft beer, wine, aperitifs, and spirits.
Measured: From enrollment until the end of the study at 10 years
Changes in smoking habits using self-composed items combined with the Fagerström Test for Nicotine Dependence (FTND).
Participants will first complete a set of self-developed questions assessing current smoking status ("never smoked", "former smoker" with years since cessation, or "current smoker"). Current smokers will additionally report the number of cigarettes smoked per day and the age at which they started smoking. In addition, participants who indicate that they currently smoke will subsequently complete the FTND, a validated six-item questionnaire that assesses the intensity of physical nicotine dependence. Longitudinal assessment will allow the evaluation of changes in smoking habits.
Measured: From enrollment until the end of the study at 10 years
Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) score.
The PSQI is a validated instrument measuring habitual sleep patterns (bedtime, sleep latency, wake-up time, and sleep duration), specific sleep disturbances, use of sleep medication, and daytime dysfunction. Responses are summed to produce a global PSQI score ranging from 0 to 21, with higher scores indicating poorer overall sleep quality. Repeated assessment enables the investigation of changes in sleep quality over time.
Measured: From enrollment until the end of the study at 10 years
Changes in body composition using Body Mass Index (BMI) and waist-to-hip ratio.
Body composition will be assessed using self-reported anthropometric measures, including weight (kg), height (m), waist circumference (cm), and hip circumference (cm). Body Mass Index (BMI) will be calculated using self-reported weight and height and expressed as kg/m². Waist and hip circumference will be used to derive additional indicators of body fat distribution, such as the waist-to-hip ratio. Changes in body composition are monitored by annual reporting of weight, height, and waist and hip circumference.
Measured: From enrollment until the end of the study at 10 years
Changes in medication adherence using the Medication Adherence Report Scale (MARS-5).
MARS-5 is a validated self-report instrument that measures the extent to which individuals adhere to their prescribed medication regimen. Participants respond to five items using a 5-point Likert scale ranging from 1 ("always") to 5 ("never"), and item scores are summed to produce a total adherence score, with higher scores indicating higher levels of medication adherence. Repeated measurements allows for evaluating possible changes in adherence.
Measured: From enrollment until the end of the study at 10 years
Changes in health-related quality of life using the Short Form-12 Health Survey (SF-12).
The SF-12 is a validated instrument that measures functional health and well-being across physical and mental domains. Responses are scored and summed to generate two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores on both components indicate better health-related quality of life. Longitudinal assessment of the SF-12 enables the evaluation of changes in quality of life over time.
Measured: From enrollment until the end of the study at 10 years
All-cause mortality incidence
Mortality incidence will be determined based on the occurrence of death during follow-up. Date and cause of death will be obtained from the participant's general practitioner and/or medical specialist.
Measured: From enrollment until the end of the study at 10 years
Self-reported hospital admissions
Hospital admission incidence will be determined based on the number of hospital admissions reported during follow-up. Participants will be asked to report the number of hospital admissions in the past year and the reason for each admission. These data will be used to assess the occurrence and causes of hospital admissions over time.
Measured: From enrollment until the end of the study at 10 years
Self-reported morbidity
Incident morbidity will be determined based on newly reported medical diagnoses during the follow-up period. Participants will be asked whether they have received a new medical diagnosis during the past year and, if applicable, to specify the diagnosis.
Measured: From enrollment until the end of the study at 10 years
Secondary outcomes (19)
Anxiety
Anxiety symptoms are measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: From enrollment until the end of the study at 10 years
Stress
Stress is measured using the 10-item Perceived Stress Scale (PSS-10). Item scores are summed to generate a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.
Measured: From enrollment until the end of the study at 10 years
Depressive symptoms
Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: From enrollment to the end of the study at 10 years
Fatigue
Fatigue is assessed using the Multidimensional Fatigue Inventory (MFI-20). The instrument comprises five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Subscale scores range from 4 to 20, with higher scores indicating greater fatigue.
Measured: From enrollment until the end of the study at 10 years
Optimism and Pessimism
Optimism and pessimism are assessed using the 10-item Life Orientation Test-Revised (LOT-R). Higher scores indicate greater optimism and higher pessimism.
Measured: From enrollment until the end of the study at 10 years
Positive and negative affect
Positive and negative affect are assessed using the Global Mood Scale (GMS). The instrument generates positive affect and negative affect scores, with higher scores indicating greater levels of the respective construct.
Measured: From enrollment until the end of the study at 10 years
Mental well-being
Mental well-being is assessed using the WHO-5 Well-Being Index. Total scores range from 0 to 100 after standard transformation, with higher scores indicating better mental well-being.
Measured: From enrollment until the end of the study at 10 years
Resilience
Resilience is assessed using the Brief Resilience Scale (BRS). Mean scores range from 1 to 5, with higher scores indicating greater resilience.
Measured: From enrollment until the end of the study at 10 years
Coping
Coping strategies are assessed using the Short Cognitive Emotion Regulation Questionnaire (CERQ-short). This validated questionnaire yields scores for multiple coping strategies, with higher scores indicating greater use of the respective strategy.
Measured: From enrollment until the end of the study at 10 years
Personality traits
Personality traits are assessed using the Big Five Inventory-2 Extra-Short Form (BFI-2-XS). The instrument provides scores for Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Open-Mindedness, with higher scores indicating greater levels of the respective personality trait.
Measured: From enrolment until the end of the study at 10 years
Social engagement
Social engagement is assessed using the Inventory of Social Engagement. Higher scores indicate greater social participation and engagement.
Measured: From enrollment until the end of the study at 10 years
Social isolation
Social isolation and loneliness are assessed using the Revised UCLA Loneliness Scale. Higher scores indicate greater perceived loneliness and social isolation.
Measured: From enrollment until the end of the study at 10 years
Partner relationship quality
The quality of the relationship with the partner is assessed using the Relationship Quality Index. Higher scores indicate better perceived quality.
Measured: From enrollment until the end of the study at 10 years
Life Events and Long-Term Difficulties
Exposure to stressful life events and persistent difficulties is assessed using the List of Threatening Experiences and the Long-Term Difficulties Inventory. Higher scores indicate greater exposure to adverse life events and ongoing difficulties.
Measured: From enrollment until the end of the study at 10 years
Physical Activity Barriers and Facilitators
Perceived barriers and facilitators for physical activity are assessed using self-composed questionnaires.
Measured: From enrollment until the end of the study at 10 years
Dietary Intake Barriers and Facilitators
Perceived barriers and facilitators for healthy dietary intake are assessed using self-composed questionnaires.
Measured: From enrollment until the end of the study at 10 years
Health-specific self-efficacy
Self-efficacy related to physical activity and healthy nutrition is assessed using health-specific self-efficacy scales. Higher scores indicate greater confidence in the ability to perform and maintain the respective health behaviour.
Measured: From enrollment until the end of the study at 10 years
Barriers of smoking cessation
Barriers to smoking cessation are assessed using the Challenges to Stopping Smoking Scale. Higher scores indicate greater perceived challenges to quitting smoking.
Measured: From enrollment until the end of the study at 10 years
Perceived need for support
Perceived need for support in achieving and maintaining lifestyle changes is assessed using self-composed questionnaires.
Measured: From enrollment until the end of the study at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846800
- Sponsor's protocol ID
- NL88127.028.24
- Acronym
- LifeMeds
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LifeMeds Cohort: Joining Forces to Assess (Determinants of) Lifestyle Behavior, Morbidity and Mortality Among Multimorbid Individuals
- ClinicalTrials.gov ID
- NCT07846800
- Acronym / sponsor ID
- LifeMeds / NL88127.028.24
- Conditions
- Multimorbidity, Cancer, Cardio Vascular Disease, Chronic Respiratory Conditions, Type 2 Diabetes
- Keywords
- Multimorbidity, Lifestyle Behavior, Determinants, Health Outcomes, Mortality, Quality of Life, Longitudinal cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 29 Sep 2026 (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.
The goal of this observational study is to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in adults with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases, including cardiovascular disease, type 2 diabetes, chronic respiratory disease, and/or cancer. The main questions it aims to answer are:
- What lifestyle trajectories can be identified over time in individuals with multimorbidity, how do these trajectories differ across multimorbidity profiles, and which psychological, social, and sociodemographic factors are associated with these trajectories?
- How are lifestyle trajectories associated with morbidity, mortality, health-related quality of life, and other major health outcomes over time?
Participants will complete one annual questionnaire during a follow-up period of ten years.
Detailed description
Background and Rationale:
Multimorbidity, commonly defined as the coexistence of two or more chronic diseases, is an increasing public health challenge associated with reduced quality of life, increased healthcare utilization, and premature mortality. Lifestyle behaviours, including physical activity, diet, smoking, alcohol consumption, sleep, and medication adherence, play an important role in the prevention and management of many chronic diseases. Although lifestyle interventions have been developed and evaluated for individual chronic diseases, considerably less is known about lifestyle behaviour patterns, their determinants, and effective lifestyle support strategies among individuals living with multimorbidity. The coexistence of multiple chronic conditions may introduce unique barriers and facilitators to lifestyle modification that are not adequately captured in single-disease research. Therefore, the LifeMeds cohort was established to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in individuals with multimorbidity over time.
Aims and Objectives:
Aim 1: To longitudinally identify lifestyle behaviours and their determinants in individuals with multimorbidity.
- Objective 1a. To investigate lifestyle trajectories of individuals with multimorbidity and to identify potential similarities and differences in lifestyle trajectories between individuals with different combinations of multimorbidity.
- Objective 1b. To identify determinants of lifestyle behaviours in individuals with multimorbidity and monitor changes over time.
- Objective 1c. To link different lifestyle trajectories to future morbidity and mortality risk.
Aim 2: To investigate the impact of multimorbidity on health outcomes and to identify the determinants associated with these outcomes.
- Objective 2a. To assess quality of life, morbidity, and mortality risk among individuals with different combinations of multimorbidity.
- Objective 2b. To identify the clinical, sociodemographic, medical, social, and psychological determinants associated with morbidity and mortality incidence in individuals with different combinations of multimorbidity.
Study Population:
Eligible participants are adults aged 18 years and older with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases. To capture the full spectrum of disease burden, disease progression, and risk of recurrence, individuals with either a current or previous diagnosis of an eligible condition will be considered for inclusion. The LifeMeds cohort focuses on chronic diseases with a strong association with lifestyle-related risk factors, including type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), chronic respiratory disease (CRD), and cancer. All cases of T2DM will be eligible for inclusion, whereas for the remaining disease groups the study will focus on the most prevalent lifestyle-related subtypes. Eligible cancer diagnoses comprise breast, colorectal, prostate, and lung/bronchus cancer. Eligible cardiovascular diseases comprise coronary artery disease, heart failure, peripheral artery disease, and hypertension, while eligible chronic respiratory diseases comprise chronic obstructive pulmonary disease (COPD) and asthma.
Study Design and Recruitment:
The LifeMeds cohort is a prospective longitudinal observational study with a planned follow-up period of 10 years. Participants will be recruited through participating hospitals and community-based recruitment strategies. In participating hospitals, eligible individuals may be informed about the study by their treating healthcare professional during routine care encounters. In addition, participants may self-register through online advertisements distributed via patient organizations and social media platforms, or through flyers distributed in community settings such as supermarkets, community centres, and pharmacies.
Individuals who meet the eligibility criteria and provide informed consent will be enrolled in the cohort. Participants will complete a baseline questionnaire followed by annual follow-up questionnaires throughout the 10-year study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimorbid individuals | – | –Individuals who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory diseases and/or cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory disease and/or cancer. To ensure sufficient homogeneity for analysing combinations of multimorbidity while still capturing clinically relevant variation, the study focuses on the most common subtypes of these conditions with aetiologies strongly linked to lifestyle. For cancer, this includes breast , colorectal, prostate and lung cancer. For cardiovascular disease subtypes include coronary artery disease, heart failure, peripheral artery disease and hypertension. Chronic respiratory disease subtypes include chronic obstructive pulmonary disease and asthma. Finally, all clinically confirmed cases of type 2 diabetes mellitus are eligible. Individuals with a history of any of these conditions are eligible, allowing the cohort to capture the full spectrum of disease progression, remission and relapse.
Key inclusion criteria (2 listed)
- Diagnosed with two or more of the following diseases: type 2 diabetes, cancer, cardiovascular disease and/or chronic respiratory diseases.
- Aged 18 years or older
Key exclusion criteria (1 listed)
- Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).
Time frame: From enrollment to the end of the study at 10 years
The SQUASH is a validated questionnaire that assesses habitual physical activity across commuting, household, leisure-time, and occupational domains. Repeated assessments over time will enable the evaluation of changes in physical activity levels.
Changes in dietary intake using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI).
Time frame: From enrollment to the end of the study at 10 years
Dietary intake is assessed using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI). The questionnaire captures key aspects of diet quality and adherence to dietary recommendations. Repeated assessments over time will enable the evaluation of changes in dietary behaviours.
Changes in alcohol consumption using a self-composed questionnaire.
Time frame: From enrollment until the end of the study at 10 years
Participants will first be asked whether they consume alcohol. Those who do will be asked to report their average weekly intake, specified in number of glasses, across four predefined categories of alcoholic beverages: beer, craft beer, wine, aperitifs, and spirits.
Changes in smoking habits using self-composed items combined with the Fagerström Test for Nicotine Dependence (FTND).
Time frame: From enrollment until the end of the study at 10 years
Participants will first complete a set of self-developed questions assessing current smoking status ("never smoked", "former smoker" with years since cessation, or "current smoker"). Current smokers will additionally report the number of cigarettes smoked per day and the age at which they started smoking. In addition, participants who indicate that they currently smoke will subsequently complete the FTND, a validated six-item questionnaire that assesses the intensity of physical nicotine dependence. Longitudinal assessment will allow the evaluation of changes in smoking habits.
Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) score.
Time frame: From enrollment until the end of the study at 10 years
The PSQI is a validated instrument measuring habitual sleep patterns (bedtime, sleep latency, wake-up time, and sleep duration), specific sleep disturbances, use of sleep medication, and daytime dysfunction. Responses are summed to produce a global PSQI score ranging from 0 to 21, with higher scores indicating poorer overall sleep quality. Repeated assessment enables the investigation of changes in sleep quality over time.
Changes in body composition using Body Mass Index (BMI) and waist-to-hip ratio.
Time frame: From enrollment until the end of the study at 10 years
Body composition will be assessed using self-reported anthropometric measures, including weight (kg), height (m), waist circumference (cm), and hip circumference (cm). Body Mass Index (BMI) will be calculated using self-reported weight and height and expressed as kg/m². Waist and hip circumference will be used to derive additional indicators of body fat distribution, such as the waist-to-hip ratio. Changes in body composition are monitored by annual reporting of weight, height, and waist and hip circumference.
Changes in medication adherence using the Medication Adherence Report Scale (MARS-5).
Time frame: From enrollment until the end of the study at 10 years
MARS-5 is a validated self-report instrument that measures the extent to which individuals adhere to their prescribed medication regimen. Participants respond to five items using a 5-point Likert scale ranging from 1 ("always") to 5 ("never"), and item scores are summed to produce a total adherence score, with higher scores indicating higher levels of medication adherence. Repeated measurements allows for evaluating possible changes in adherence.
Changes in health-related quality of life using the Short Form-12 Health Survey (SF-12).
Time frame: From enrollment until the end of the study at 10 years
The SF-12 is a validated instrument that measures functional health and well-being across physical and mental domains. Responses are scored and summed to generate two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores on both components indicate better health-related quality of life. Longitudinal assessment of the SF-12 enables the evaluation of changes in quality of life over time.
All-cause mortality incidence
Time frame: From enrollment until the end of the study at 10 years
Mortality incidence will be determined based on the occurrence of death during follow-up. Date and cause of death will be obtained from the participant's general practitioner and/or medical specialist.
Self-reported hospital admissions
Time frame: From enrollment until the end of the study at 10 years
Hospital admission incidence will be determined based on the number of hospital admissions reported during follow-up. Participants will be asked to report the number of hospital admissions in the past year and the reason for each admission. These data will be used to assess the occurrence and causes of hospital admissions over time.
Self-reported morbidity
Time frame: From enrollment until the end of the study at 10 years
Incident morbidity will be determined based on newly reported medical diagnoses during the follow-up period. Participants will be asked whether they have received a new medical diagnosis during the past year and, if applicable, to specify the diagnosis.
19 secondary outcomes
Anxiety
Time frame: From enrollment until the end of the study at 10 years
Stress
Time frame: From enrollment until the end of the study at 10 years
Depressive symptoms
Time frame: From enrollment to the end of the study at 10 years
Fatigue
Time frame: From enrollment until the end of the study at 10 years
Optimism and Pessimism
Time frame: From enrollment until the end of the study at 10 years
Positive and negative affect
Time frame: From enrollment until the end of the study at 10 years
Mental well-being
Time frame: From enrollment until the end of the study at 10 years
Resilience
Time frame: From enrollment until the end of the study at 10 years
Coping
Time frame: From enrollment until the end of the study at 10 years
Personality traits
Time frame: From enrolment until the end of the study at 10 years
Social engagement
Time frame: From enrollment until the end of the study at 10 years
Social isolation
Time frame: From enrollment until the end of the study at 10 years
Partner relationship quality
Time frame: From enrollment until the end of the study at 10 years
Life Events and Long-Term Difficulties
Time frame: From enrollment until the end of the study at 10 years
Physical Activity Barriers and Facilitators
Time frame: From enrollment until the end of the study at 10 years
Dietary Intake Barriers and Facilitators
Time frame: From enrollment until the end of the study at 10 years
Health-specific self-efficacy
Time frame: From enrollment until the end of the study at 10 years
Barriers of smoking cessation
Time frame: From enrollment until the end of the study at 10 years
Perceived need for support
Time frame: From enrollment until the end of the study at 10 years
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity and Cancer, run by Tilburg University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Mirela Habibović, PhD (31134664020, M.Habibovic@tilburguniversity.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). (time frame: From enrollment to the end of the study at 10 years). The study lists 11 primary outcomes in all. 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 29 Sep 2026.