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Status unknownNCT04842214Updated Sep 21, 2022

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

An observational study in Oncologic Disorders, sponsored by Klinik Valens. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Klinik Valens · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Oncologic Disorders

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Keywords

  • Oncologic Rehabilitation
  • Cancer-related Fatigue
  • Patient-reported Outcome Measurement Information System (PROMIS)
03

In context

Disease Progression

544 studies on the registry are indexed under Disease Progression; 144 are open to participants now.

This study's planned enrollment of 250 is above the median of 198 across 260 observational studies indexed under Disease Progression.

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Lead sponsor

Klinik Valens is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with oncologic disorders assigned for inpatient rehabilitation.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Oncologic disorders

    All patients assigned for oncological rehabilitation with the diagnosis "Cancer" are included to this cohort.

    Behavioral: Oncological Rehabilitation

Interventions

  • BehavioralOncological Rehabilitation

    Multidimensional rehabilitation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three months (Day 0-Day 92) with time points set after three weeks (Day 21) and three months (Day 92)

Secondary outcomes

  1. 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.

    Time frame: Three months (Day 0 - Day 92) with time points set after three weeks (Day 21) and three months after discharge (Day 92)

  2. 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.

    Time frame: Three weeks (Day 0 - Day 21)

  3. 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.

    Time frame: Three weeks (Day 0 - Day 21)

  4. 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.

    Time frame: Three weeks (Day 0 - Day 21)

  5. 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.

    Time frame: Three weeks (Day 0 - Day 21)

  6. 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

    Time frame: Three weeks (Day 0 - Day 21)

07

Study locations

1 site
  • Kliniken-Valens
    Valens, Sankt Gallen 7317, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04842214
Lead sponsor
Klinik Valens
Responsible party
Jens Bansi (Head of Research and Development, Klinik Valens) — Principal investigator
First posted
Apr 13, 2021
Start date
Jan 1, 2019
Primary completion
May 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Sep 21, 2022
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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