Clinical trial NCT04842214: Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up
Official title: Evaluation of Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up: a Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncologic Disorders
Keywords: Oncologic Rehabilitation
Cancer-related Fatigue
Patient-reported Outcome Measurement Information System (PROMIS)
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with oncologic disorders assigned for inpatient rehabilitation.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with "Cancer";
* Literacy and understanding German language;
* Signed informed consent;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)
Secondary outcomes:
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92)
measure: Functional Independence Measure (FIM)
timeFrame: Three weeks (Day 0 - Day 21)
measure: EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)
timeFrame: Three weeks (Day 0 - Day 21)
measure: Six Minute Walking Test (6MWT)
timeFrame: Three weeks (Day 0 - Day 21)
measure: Timed-Up-and-Go (TUG)
timeFrame: Three weeks (Day 0 - Day 21)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Three weeks (Day 0 - Day 21)
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Kliniken-Valens
state: Sankt Gallen
Study officials:
References: