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NCT03844347: C-Bien
Well-being and Stress Control After Colorectal Surgery
NA trial testing Stress management sessions in Patients with Colorectal Cancer in 154 participants. Terminated before completion.
3 August 2024
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 154 |
| Start date | 21 October 2019 |
| Primary completion | 3 August 2024 |
| Estimated completion | 5 September 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Stress management sessions
Conditions studied
- Patients with Colorectal Cancer — all drugs for Patients with Colorectal Cancer →
- Surgery — all drugs for Surgery →
Sponsor
University Hospital, Strasbourg, France
Who can join
18 and older, any sex, with Patients with Colorectal Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The criteria usually considered to evaluate the quality of life are the presence or absence of a stomy, alteration of the transit or the sexual dysfunctions. Quality of life has been improved by introducing an Enhanced Postoperative Rehabilitation Program After Surgery (ERAS). It is a multidisciplinary medical and paramedical care aimed at minimizing the sources of stress allowing a significant reduction in postoperative complications and length of stay. However, the emotional feelings of patients, their fatigue, the quality of their relationships with others and their experience of the disease are not usually considered. Nevertheless, these criteria influence the quality of life and constitute the fundamental bases of the psychological well-being, essential in the recovery processes. We propose to enrich the ERAS program by introducing an individualized support of well-being and stress management aimed at increasing the quality of life of patients. The purpose is to make the patient more autonomous by allowing him/her, to implement stress management exercises. The main goal of the project is to improve the psychological well-being of patients operated on for colorectal cancer by offering stress management sessions in order to promote postoperative rehabilitation. The secondary objectives are to demonstrate the impact of stress management sessions on the length of stay and to study the link between the efficiency of these sessions and the quality of life of patients before the surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03844347
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03844347 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03844347.
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