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Implementation and evaluation of a home-based training and care program for physical and mental stabilization in colorectal, breast and prostate cancer - telemonitoring and self-management

Organizational Data

DRKS-ID:
DRKS00020499
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-03-17
Last update in DRKS:
2024-01-03
Registration type:
Prospective

Acronym/abbreviation of the study

CRBP-TS

URL of the study

No Entry

Brief summary in lay language

Prostate cancer, breast cancer and colorectal cancer are frequent malignant tumor diseases in men and women, with approximately 60,000 to 70,000 new cases each per year. The causes for the development of cancer are multiple and in wide parts unclear. Genetic factors, environmental influences and eating habits play a role. Regular physical exercise is one of the most effective forms of prevention of colon, breast and prostate cancer (CRBP). For adults, at least 150 minutes of moderate or 75 minutes of intensive exercise per week is recommended for cancer prevention. Several studies have shown a reduction in tumour-specific mortality and recurrence of the tumour disease by 20 to 40% due to physical exercise. The CRBP-TS care project combines online-supported physical training and the automated recording of activity and performance parameters with an electronic case file (ESF) accessible by the patient and treating physicians, in which the data obtained are presented. The short and medium-term aims of CRBP-TS are to increase performance, muscle mass, reduce fat tissue, improve quality of life and reduce depression. The long-term goal is the reduction of tumour-specific and general mortality.

Brief summary in scientific language

Prostate cancer and breast cancer are the most frequent malignant tumor diseases in men and women, with approximately 60,000 to 70,000 new incidences each year. Colorectal carcinoma affects women and men with a total of approx. 60,000 new cases per year and the trend is rising. There are multiple causes for the development of cancer and often unknown. Regular physical exercise is one of the most effective primary and secondary forms of prevention. Part of the guidelines for the individual tumor entities is therefore the systematic application of physical training in the postoperative therapy. Overall, a representative number of meta-studies prove the effectiveness of training for colorectal, mammary and prostate carcinoma (CRBP). Combined endurance and strength training are an effective, supportive therapy in addition to conventional treatments, with a strong reduction of short- and medium-term tumor complications as well as tumor-specific morbidity and recurrence or metastasis rates. The risk reduction due to training is assumed to be approx. 20-40% for CRBP carcinomas. The available studies are mainly based on questionnaire surveys using instructions for lifestyle changes and a qualitative implementation of the training programs with subjective assessment of the intensity. Despite the strong evidence base and the impressive preventive, protective and regenerative efficiency of physical training, there is no systematic implementation strategy or care structure in certified tumor therapy. The CRBP-TS project addresses this situation and combines online-based training and automated recording of activity and performance parameters with cross-sectoral bi-directional data evaluation and online communication via an electronic case file (ESF) accessible by the patient and treating physician.

Health condition or problem studied

ICD10:
C18 - Malignant neoplasm of colon
ICD10:
C19 - Malignant neoplasm of rectosigmoid junction
ICD10:
C20 - Malignant neoplasm of rectum
ICD10:
C50 - Malignant neoplasm of breast
ICD10:
C61 - Malignant neoplasm of prostate
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Individualized (at least 3 per week over 30 min) strength/endurance training by an online video presentation and 1 per week of outdoor training (depending on the patient, jogging, walking, cycling, fitness facilities, rehabilitation sports, etc.).
Arm 2:
Control group receives standard care according to current guidelines.

Endpoints

Primary outcome:
Patients in the IG have a 13% higher VO2max after 6 months of intervention.
Secondary outcome:
- significant improvement in the results of tumour-specific accompanying measurements (liquid biopsy, CTC, cfDNA, ctDNA, microRNA) and tumour markers - significant reduction of hospitalizations by 15% in the IG compared to the KG - significant improvement of quality of life, fatique, depression (improvement of scores by 10%) - increase of the energy consumption by 500 kcal (or 500 met/min) per week in the IG compared to the KG - increase in patient compliance in the IG (95%) compared to the KG

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Medizinische Hochschule Hannover Hannover
  • University medical center Medizinische Hochschule Hannover Hannover
  • Medical center Sana Klinikum Borna Borna
  • University medical center Universitätsklinikum Leipzig Leipzig
  • University medical center Universitätsklinikum Dresden Dresden

Recruitment period and number of participants

Planned study start date:
2020-07-01
Actual study start date:
2020-09-01
Planned study completion date:
2021-12-31
Actual Study Completion Date:
2022-06-30
Target Sample Size:
300
Final Sample Size:
148

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
75 Years
Additional Inclusion Criteria:
- Patients according to TNM status (UICC 8th. Ed.) for tumor resection of the primary case (carcinomas ICD): C18/19/20 colorectal, C50 breast, C61 prostate. - T-stage: T1 to T3; N-stage: each N; M-stage: M0. In addition, patients with pre-surgical neoadjuvant pre-treatment as well as distant metastases (M1 stage) can be included in synchronous or metachronous RO resection (regarding primary tumor) and without intermediate chemotherapy. - Age between 18 and 75 years - ECOG congestion of 1 or better and without acute cardiac, renal, hepatic, endocrine, bone marrow or cerebral impairment

Exclusion Criteria

- Complications after tumor surgery, which prolong the convalescence and limit the physical activity relevant for the program - Presence of a second malignant tumour if therapy was less than 5 years ago - Contraindication for the sports programme: orthopaedic, rheumatological, cardiovascular or neurological diseases and muscular diseases - Any acute and active disease that prevents the termination of participation in the study - Active alcohol abuse and consumption of illegal drugs within the last 6 months before inclusion in the study - Lack of patient compliance

Addresses

Primary Sponsor

University Leipzig, Institute of Sport Medicine & Prevention
Marschnerstr. 29a
04109 Leipzig
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

University Leipzig, Institute of Sport Medicine & Prevention
Prof. Dr. med. Martin Busse
Marschnerstr. 29
04109 Leipzig
Germany
Telephone:
+49 341 9731660
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

University Leipzig, Institute of Sport Medicine & Prevention
Dr. Roberto Falz
Marschnerstr. 29
04109 Leipzig
Germany
Telephone:
+49 341 9731646
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

University Leipzig, Institute of Sport Medicine & Prevention
Prof. Dr. med. Martin Busse
Marschnerstr. 29
04109 Leipzig
Germany
Telephone:
+49 341 9731660
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Sächsisches Staatsministerium für Wissenschaft, Kunst & Tourismus
Wigardstr. 17
01097 Dresden
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale Poststelle
Liebigstraße 18
04103 Leipzig
Germany
Telephone:
+49-341-9715490
Fax:
+49-341-9715499
Contact per E-Mail
URL:
http://home.uni-leipzig.de/ethik

Vote of leading Ethics Committee

Date of ethics committee application:
2020-02-03
Ethics committee number:
056/20-ek
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-02-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Data are published via publications; study protocol, data analysis and raw data can be made available via the authors.

Study protocol and other study documents

Study protocols:
Falz R, Thieme R, Tegtbur U, Bischoff C, Leps C, Hillemanns P, Kohlhaw K, Klempnauer J, Lordick F, Stolzenburg JU, Aktas B, Weitz J, Bork U, Wimberger P, Thomas C, Biemann R, Jansen-Winkeln B, Schulze A, Gockel I, Busse M. CRBP-TS - evaluation of a home-based training and health care program for colorectal, breast, and prostate cancer using telemonitoring and self-management: study protocol for a randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Feb 23;13(1):15. doi: 10.1186/s13102-021-00244-w. PMID: 33622370; PMCID: PMC7901214. Format:
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Falz R, Bischoff C, Thieme R, Tegtbur U, Hillemanns P, Stolzenburg JU, Aktas B, Bork U, Weitz J, Lässing J, Leps C, Voß J, Lordick F, Schulze A, Gockel I, Busse M. Effect of home-based online training and activity feedback on oxygen uptake in patients after surgical cancer therapy: a randomized controlled trial. BMC Med. 2023 Aug 8;21(1):293. doi: 10.1186/s12916-023-03010-6. PMID: 37553660; PMCID: PMC10408062.
Darmochwal S, Bischoff C, Thieme R, Gockel I, Tegtbur U, Hillemanns P, Schulze A, Voss J, Falz R, Busse M. Impact of home-based training and nutritional behavior on body composition and metabolic markers in cancer patients: data from the CRBP-TS study. Front Nutr. 2023 Sep 19;10:1152218. doi: 10.3389/fnut.2023.1152218. PMID: 37794972; PMCID: PMC10546323.
Date of first publication of study results:
2023-08-08
DRKS entry published for the first time with results:
2024-01-03

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
One hundred twenty-two patients (62 intervention and 60 control group) completed the study period. Change in oxygen uptake between intervention and control patients was 1.8 vs. 0.66 ml/kg/min (estimated difference after 6 months: 1.24; 95% CI 0.23 to 2.55; p = 0.017). Rate pressure product was reduced in IG (estimated difference after 6 months: − 1079; 95% CI − 2157 to − 1; p = 0.05). Physical activity per week was not different in IG and CG. There were no significant interaction effects in body composition, cardiac output, C-reactive protein, or quality of life.