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

NCT04842214 | Unknown

• 1 other identifier: Bansi-2021
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncologic Disorders

Keywords

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

Outcome Measures

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.

  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)

  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)

  Three weeks (Day 0 - Day 21)

• EuroQoL-Group five dimension quality of life questionnaire (EQ-5D)

  Three weeks (Day 0 - Day 21)

• Six Minute Walking Test (6MWT)

  Three weeks (Day 0 - Day 21)

• Timed-Up-and-Go (TUG)

  Three weeks (Day 0 - Day 21)

Study Arms (1)

Oncologic disorders

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

Behavioral: Oncological Rehabilitation

Interventions

Oncological Rehabilitation BEHAVIORAL

Multidimensional rehabilitation

Oncologic disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with oncologic disorders assigned for inpatient rehabilitation.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Klinik Valens: lead

Study Sites (1)

Kliniken-Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: January 1, 2019
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)