Trial document



drksid header

  DRKS00020822

Trial Description

start of 1:1-Block title

Title

On board! Rehabilitation after colorectal cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MIRANDA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Cancer and chemotherapy are often accompanied by exhaustion and pronounced tiredness, which cannot be improved by resting. This is known as cancer-related fatigue. One-third of colorectal cancer survivors suffer from fatigue shortly after initial treatment, but sometimes even years after the end of cancer therapy. Despite the heavy burden on the individual colorectal cancer patient, cancer-related fatigue is not adequately addressed in research. So far, only non-pharmacologic approaches have been shown to be effective.
The MIRANDA study is an observational study and serves to establish a study cohort of patients with non-metastatic ("non-scattering") colorectal cancer that is representative of the German rehabilitation setting. The included patient population will be monitored over a maximum period of 10 years.
The main criteria for participation in the study are hospitalization in one of the cooperating rehabilitation clinics for at least three weeks, diagnosis of non-metastatic colorectal cancer, and surgical removal of the tumor within the past nine months.
The aim of the cohort study is to gain insights into risk, prevention and prognosis factors (including blood, stool and urine biomarkers and genetic factors) of colorectal cancer in general and cancer-related fatigue in particular. The required information from study participants will be obtained by using questionnaires as well as blood, urine, and stool samples.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In Germany, there are more than 60,000 new cases of colorectal cancer and more than 25,000 deaths from colorectal cancer per year. Although the prognosis has particularly improved for the early stages of the disease, detriments in the quality of life often persist. The occurrence of cancer-related fatigue is a major cause of reduced quality of life. One-third of colorectal cancer survivors suffer from fatigue shortly after initial treatment, but sometimes even years after the end of cancer therapy. Despite the heavy burden on the individual colorectal cancer patient, cancer-related fatigue is not adequately addressed in research. So far, only non-pharmacologic approaches have been shown to be effective.

The MIRANDA study is an observational study and serves to establish a study cohort of patients with non-metastatic ("non-scattering") colorectal cancer that is representative of the German rehabilitation setting. The included patient population will be monitored over a maximum period of 10 years. The main criteria for participation in the study are hospitalization in one of the cooperating rehabilitation clinics for at least three weeks, diagnosis of non-metastatic colorectal cancer, and surgical removal of the tumor within the past nine months. The aim of the cohort study is to gain insights into risk, prevention and prognosis factors (including blood, stool and urine biomarkers and genetic factors) of colorectal cancer in general and cancer-related fatigue in particular. The required information from study participants will be obtained by using questionnaires as well as blood, urine, and stool samples. Endpoints, such as cancer-related fatigue, symptoms of depression, quality of life, and functional well-being will be assessed using validated questionnaire instruments (FACIT-F-FS, EORTC-FA-12, GDS-15, EORTC-QLQ-C30, and FACIT-F-FWB) and newly developed questionnaire instruments (e.g. for infection frequency and return to work) every 3 months in the first year and then after 3, 5, 7 and 10 years. Fatalities with causes of death are determined by register matching. At the beginning of the study, blood, urine and stool samples are collected to measure biomarkers and perform genetic analyses. A further stool sample is collected in the fourth month of the study to allow a longitudinal analysis of the microbiome.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

The data is not published to an Open Access Platform. After completion of the study, interested scientists can request data use and receive pseudonymized data upon approval of this application by the sponsor.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020822
  •   2020/02/18
  •   [---]*
  •   yes
  •   Approved
  •   S-905/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
  •   C21 -  Malignant neoplasm of anus and anal canal
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   At the begin of rehabilitation (baseline):
    • self-administered questionnaires (see primary and secondary endpoints for further details)
    • measurement of height, weight and waist circumference
    • blood sampling: serum (25(OH)D level, creatinine, calcium, phosphate, albumin, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, C-reactive protein, uric acid), whole blood (hemoglobin, HbA1c, white blood cell count, leukocyte subtype counts) and buffy coat from EDTA Plasma (genome)
    • urine sampling (calcium and creatinine)
    • stool sampling (microbiome)
    • pregnancy test for premenopausal women

    Long-term follow-up:
    • self-administered questionnaires at study month 4, 7, 10 and after 1, 3, 5, 7, 10 years (see primary and secondary endpoints for further details)
    • stool sampling in study month 4 (microbiome)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

• Cancer-related fatigue assessed by using validated questionnaires (FACIT-F and EORTC-QLQ-FA12) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

• Overall and domain-specific quality of life assessed by using a validated questionnaire tool (EORTC-QLC C30) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years
• Colorectal cancer-specific quality of life assessed by using a validated questionnaire tool (EORTC-QLQ CR29) in month 10
• Distress in cancer assessed by using a validated questionnaire tool (QSC-R10) in month 10
• Functional well-being assessed by using a validated questionnaire tool (FACIT-F-FWB) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years
• Infection frequencies (total, upper respiratory and lower respiratory tract infections) assessed by self-report of study participants in month 4 and after 1, 3, 5, 7, 10 years
• Return to work assessed by self-report of study participants and by using the count of paid working hours in month 4, 7, 10 and after 1, 3, 5, 7, 10 years
• Disease-related early retirement assessed by self-report of study participants after 1 year
• Frailty assessed by using a validated questionnaire tool (FRAIL-Scale) after 1, 3, 5, 7, 10 years
• Falls, fractures including (non-)vertebral and hip fractures assessed by self-report of study participants after 1, 3, 5, 7, 10 years
• Depressive symptoms assessed by using a validated questionnaire tool (GDS-15) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years
• Depressive episodes assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Anxiety assessed by using a validated questionnaire tool (GAD-7) after 1 year
• Cancer incidence assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Cancer mortality (ICD-10 code C00-C97, D00-D09 or D37-48 as leading cause of death) assessed by register matching after 1, 3, 5, 7 and 10 years
• Colorectal-cancer mortality (ICD-10 code C18-C21 as leading cause of death) assessed by register matching after 1, 3, 5, 7 and 10 years
• Cardiovascular disease mortality (ICD-10 code I00-I99 as leading cause of death) assessed by register matching after 1, 3, 5, 7 and 10 years
• All-cause mortality assessed by the count to all deaths after 1, 3, 5, 7 and 10 years
• Incidence of myocardial infarction and coronary heart disease assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Incidence of stroke assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Incidence of type 2 diabetes mellitus assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Incidence of osteoporosis assessed by self-report of study participants after 1, 3, 5, 7 and 10 years
• Microbiome assessed by obtaining a stool sample in month 4

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/04/30
  •   1000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Non-metastatic colorectal cancer patients (ICD-10 C18-21) with Union for International Cancer Control (UICC) stage I-III
• Within 9 months after surgical removal of the tumor
• At least 3 weeks of in-patient rehabilitation in a cooperating clinic are planned
• Sufficient knowledge of the German language and mental capability to be able to give written informed consent and comply with the study requirements

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Subjects who do not consent to participate or who are incapable of giving their own consent will be excluded

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsches Krebsforschungszentrum (DKFZ)
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Deutsches Krebsforschungszentrum (DKFZ) - Abteilung Klinische Epidemiologie und Alternsforschung
    • Mr.  PD Dr.  Ben  Schöttker 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Deutsches Krebsforschungszentrum (DKFZ) - Abteilung Klinische Epidemiologie und Alternsforschung
    • Ms.  Isabel  Lerch 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsches Krebsforschungszentrum (DKFZ)
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.