Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up

Oncologic Disorders Clinical Trial

Official title:

Evaluation of Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up: a Cohort Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04842214
• Other study ID #: Bansi-2021
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2022
• Source: Klinik Valens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Oncologic Disorders

Intervention

Behavioral:
• Oncological Rehabilitation
Multidimensional rehabilitation

Locations

Country	Name	City	State
Switzerland	Kliniken-Valens	Valens	Sankt Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)
Secondary	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.	Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92)
Secondary	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.	Three weeks (Day 0 - Day 21)
Secondary	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.	Three weeks (Day 0 - Day 21)
Secondary	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.	Three weeks (Day 0 - Day 21)
Secondary	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.	Three weeks (Day 0 - Day 21)
Secondary	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	Three weeks (Day 0 - Day 21)