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

September 20, 2022 updated by: Jens Bansi, Klinik Valens

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Sankt Gallen
      • Valens, Sankt Gallen, Switzerland, 7317
        • Kliniken-Valens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with oncologic disorders assigned for inpatient rehabilitation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oncologic disorders
All patients assigned for oncological rehabilitation with the diagnosis "Cancer" are included to this cohort.
Behavioral: Oncological Rehabilitation
Multidimensional rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Functional Independence Measure (FIM)
Time Frame: Three weeks (Day 0 - Day 21)
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)
EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)
Time Frame: Three weeks (Day 0 - Day 21)
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)
Six Minute Walking Test (6MWT)
Time Frame: Three weeks (Day 0 - Day 21)
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)
Timed-Up-and-Go (TUG)
Time Frame: Three weeks (Day 0 - Day 21)
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)
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Three weeks (Day 0 - Day 21)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik Valens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

May 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (ACTUAL)

April 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bansi-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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