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

Not Applicable

• Conditions: C18; C19; C20; C50; C61; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum; Malignant neoplasm of breast; Malignant neoplasm of prostate

• Registration Number: DRKS00020499
• Lead Sponsor: niversity Leipzig, Institute of Sport Medicine & Prevention

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Study Completion: 2022-06-30
• Results First Posted: 2023-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients in the IG have a 13% higher VO2max after 6 months of intervention.

Secondary Outcome Measures

Name	Time	Method
- significant improvement in the results of tumour-specific accompanying measurements (liquid biopsy, CTC, cfDNA, ctDNA, microRNA) and tumour markers<br>- significant reduction of hospitalizations by 15% in the IG compared to the KG<br>- significant improvement of quality of life, fatique, depression (improvement of scores by 10%)<br>- increase of the energy consumption by 500 kcal (or 500 met/min) per week in the IG compared to the KG<br>- increase in patient compliance in the IG (95%) compared to the KG