Oncologic DisordersNCT04842214
Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up
An observational study of Oncologic Disorders, run by Klinik Valens at 1 site in Switzerland.
Trial summary
Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disorders
- What is being tested?
- Oncological Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with oncologic disorders assigned for inpatient rehabilitation.
Who may be able to join
- Diagnosed with "Cancer";
- Literacy and understanding German language;
- Signed informed consent;
Who cannot join
- Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study;
- Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc);
- Known or suspected non-compliance, drug or alcohol abuse;
- Inability to follow the procedures of the study: e.g. due to language problems, psychological disorders, dementia of the participant, etc;
- Enrolment of the investigator, his/her family members, employees and other dependent persons;
- Cognitive impairment: Mini-Mental State Examination (MMSE) < 21;
- Major Depression or Hospital Anxiety and Depression Scale (HADS) >11 at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up: a Cohort Study.
Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Meta-analysis have shown the effectiveness of multidimensional rehabilitation programs concerning cost-effectiveness and for improving different health parameters. However when submitted to oncological rehabilitation in Switzerland there is no clear definition when to use which specific assessment during the different stages of oncological rehabilitation.
This cohort study aims to evaluate and systematically follow-up patients that are assigned for oncological inpatient rehabilitation at the Rehabilitation Center Walenstadtberg.
The main purposes are i) to evaluate disease onset of oncological patients during rehabilitation and to identify relationships between mobility and cancer-related fatigue at discharge; ii) to identify predictive factors for everyday functioning and social participation after three months discharge.
- Conditions
- Oncologic Disorders
- Being tested
- Oncological Rehabilitation
- Keywords
- Oncologic Rehabilitation, Cancer-related Fatigue, Patient-reported Outcome Measurement Information System (PROMIS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological RehabilitationBehavioural
Multidimensional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Oncologic disorders | All patients assigned for oncological rehabilitation with the diagnosis "Cancer" are included to this cohort. Receives: Behavioral: Oncological Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS)
Change of participants' physical and mental health over three weeks training and after three months discharge (follow-up). The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score with higher scores indication better physical and/or mental health.
Measured: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)
Secondary outcomes (6)
Multidimensional Fatigue Inventory (MFI)
Changes of cancer-related fatigue over three training weeks and after three months follow-up. The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. The scale ranges from 1 to 7 with higher total scores indicating acute levels of fatigue.
Measured: Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92)
Functional Independence Measure (FIM)
Changes of participants functional independencies of performing a task over three weeks training. The FIM is a 18-item self-report instrument designed to measure participants functional independency. Items are divided into motor and cognitive categories, are classified based on the type of task it involves and are scored on a 7-point likert scale. Higher scores indicate more independencies a person has at performing the task. The score is a value ranging between 18 and 126 (total score) and is further broken down based on its motor and cognitive components. The motor component ranges from 13 to 91, while the cognitive component ranges between 5 to 35.
Measured: Three weeks (Day 0 - Day 21)
EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)
Changes of participant's health state over three weeks training with higher scores indicating a better health status.EQ-5D comprises the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is expressed with the levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by scoring the most appropriate statement for each dimension. This decision results into a 1-digit number that expresses the level selected for the respective dimension. The digits for the five dimensions are combined into a 5-digit number.
Measured: Three weeks (Day 0 - Day 21)
Six Minute Walking Test (6MWT)
Changes of walking speed and distance covered after in 6-Minutes over three weeks training. The greater the distance covered after six minutes the higher the walking speed.
Measured: Three weeks (Day 0 - Day 21)
Timed-Up-and-Go (TUG)
Changes of mobility and risk of falling over three weeks training. The TUG measures the time for the participant to stand from a chair, walk three meters and sit down again. Time stops when the participants is seated. Cut-off for risk of falling is set for dwelling adults at 13.5 and for vestibular disorders at 11.1 seconds.
Measured: Three weeks (Day 0 - Day 21)
Hospital Anxiety and Depression Scale (HADS)
Changes of anxiety and depression over three weeks training on a 4-point likert scale scored 0-3. Max 21 Points for each subscale, cut off for anxiety and Depression are set at 7 points with higher values representing more anxiety and depressive symptoms symptoms
Measured: Three weeks (Day 0 - Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jan 2019
- Primary completion30 May 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DisordersStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Bansi, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842214
- Sponsor's protocol ID
- Bansi-2021
- Status last verified
- Sep 2022
- First submitted
- 8 Apr 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up: a Cohort Study.
- ClinicalTrials.gov ID
- NCT04842214
- Acronym / sponsor ID
- Bansi-2021
- Conditions
- Oncologic Disorders
- Keywords
- Oncologic Rehabilitation, Cancer-related Fatigue, Patient-reported Outcome Measurement Information System (PROMIS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Apr 2021 (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.
Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Meta-analysis have shown the effectiveness of multidimensional rehabilitation programs concerning cost-effectiveness and for improving different health parameters. However when submitted to oncological rehabilitation in Switzerland there is no clear definition when to use which specific assessment during the different stages of oncological rehabilitation.
This cohort study aims to evaluate and systematically follow-up patients that are assigned for oncological inpatient rehabilitation at the Rehabilitation Center Walenstadtberg.
The main purposes are i) to evaluate disease onset of oncological patients during rehabilitation and to identify relationships between mobility and cancer-related fatigue at discharge; ii) to identify predictive factors for everyday functioning and social participation after three months discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncologic disorders | – | Behavioral: Oncological RehabilitationAll patients assigned for oncological rehabilitation with the diagnosis "Cancer" are included to this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oncologic disorders assigned for inpatient rehabilitation.
Key inclusion criteria (3 listed)
- Diagnosed with "Cancer";
- Literacy and understanding German language;
- Signed informed consent;
Key exclusion criteria (7 listed)
- Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study;
- Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc);
- Known or suspected non-compliance, drug or alcohol abuse;
- Inability to follow the procedures of the study: e.g. due to language problems, psychological disorders, dementia of the participant, etc;
- Enrolment of the investigator, his/her family members, employees and other dependent persons;
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 |
|---|---|---|
| Oncological RehabilitationMultidimensional rehabilitation | Behavioural | Oncologic disorders |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)
Change of participants' physical and mental health over three weeks training and after three months discharge (follow-up). The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score with higher scores indication better physical and/or mental health.
6 secondary outcomes
Multidimensional Fatigue Inventory (MFI)
Time frame: Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92)
Functional Independence Measure (FIM)
Time frame: Three weeks (Day 0 - Day 21)
EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)
Time frame: Three weeks (Day 0 - Day 21)
Six Minute Walking Test (6MWT)
Time frame: Three weeks (Day 0 - Day 21)
Timed-Up-and-Go (TUG)
Time frame: Three weeks (Day 0 - Day 21)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Three weeks (Day 0 - Day 21)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Disorders, run by Klinik Valens at 1 site in Switzerland.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Switzerland. 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. 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?
Results are not available in the source record.
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?
Patient Reported Outcomes Measurement Information System (PROMIS) (time frame: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)). 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 21 Sep 2022.