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ID
Source
Brief title
Health condition
Stage 3 colon carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility and effectiveness
Secondary outcome
N/A
Background summary
In the Netherlands, each year 5,000 people are diagnosed with colon carcinoma with lymph node metastases. These so-called stage 3 colon carcinoma patients require adjuvant chemotherapy to improve survival rates. If this adjuvant chemotherapy cannot be started in time or cannot be fully completed, 5-year survival rates decrease from 75% to 39%. Due to the high risk of complications after surgery (approximately 30-60%), postoperative recovery is often delayed. As a result, in only 50% of patients adjuvant chemotherapy is started in time. Moreover, 50% of the patients undergoing adjuvant chemotherapy drop out or receive a dose reduction due to side effects. Research has shown that optimizing the condition by a multimodal program prior to surgery (prehabilitation) increases a patient’s resilience to withstand surgery. As a results, postoperative complication rates decrease and functional recovery enhances. By analogy, it can be suggested that a comparable program after surgery both ensures patients to start chemotherapy in time and ensures patients to better tolerate adjuvant chemotherapy. This pilot study will be performed to determine the feasibility and effectiveness of a multimodal revalidation program prior to and during adjuvant chemotherapy in patients with stage 3 colon carcinoma.
Study objective
A multimodal revalidation program after surgery ensures patients to start chemotherapy in time and ensures patients to better tolerate adjuvant chemotherapy.
Study design
Feasibility will be evaluated by:
- safety: occurance of side effects/complications as a result of the intervention
- adherence of the intervention by patients
- fidelity of the intervention by fysiotherapists
- satisfaction of both patients as fysiotherapists
- practicability of the intervention
- implementability of the intervention
Potential effectiveness will be evaluated by
1. Self-reported functional recovery: difference in physical activity between start and end of revalidation program
2. Observed functional recovery: difference between start and end of revalidation program in quality of life, performance status, fatigue, short physical perforamce battery, maximal exertion, muscle strength, anthropometry, fat-free body mass, nutritional status
3. Time between surgical procedure and start of adjuvant chemotherapy
4. Side effects of adjuvant chemotherapy
5. Compliance of adjuvant chemotherapy
Intervention
Multimodal revalidation program including high intensity interval training and resistance training
Inclusion criteria
Adult patients (>18 years) with stage 3 colon carcinoma eligible for treatment with adjuvant chemotherapy
Exclusion criteria
Patients <18 years
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8603 |
Other | CMO Regio Arnhem-Nijmegen : 2020-6554 (dossiernummer) |