Clinical Trials Logo

Clinical Trial Summary

The purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the W&W program for rectal cancer


Clinical Trial Description

The watch-and-wait (W&W) strategy in rectal cancer is a organ-sparing treatment option, where patients with a clinical complete response (cCR) after neoadjuvant chemo(radio)therapy, do not undergo surgery but instead follow a strict follow-up scheme. The goal of the W&W strategy is to preserve the rectum and thereby retain functional outcomes (FO) (e.g. gastro-intestinal, urinary, sexual) and improve quality of life (QoL). Patient Reported Outcome Measures (PROMs) reflect the patients' evaluation of their symptoms, FO and QoL. In the W&W program various PROMs (e.g. EORTC-CR29/C30, LARS, SF-36) are used to assess the these different outcomes. However, most of the PROMs used are developed and validated in a surgical patient group. So the relevance and usefulness of these PROMs may be limited in W&W patients. For use in clinical practice, a short PROM would support follow-up care as it provides a clear overview of the problems W&W patients experience. This paper describes the protocol for the development of an international tool that can be used to assess burden of disease in patients enrolled in the W&W program for rectal cancer. We will use the Delphi methodology to reach consensus about items that should be included in the novel tool. The aim of this tool is to improve direct patient care during the entire Watch-and-Wait program. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05040646
Study type Observational
Source Maastricht University Medical Center
Contact Alexander Pennings, MD
Phone +31 43 38 82449
Email [email protected]
Status Not yet recruiting
Phase
Start date October 1, 2021
Completion date June 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04323722 - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer N/A
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT01347697 - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer N/A
Not yet recruiting NCT04893876 - The OPERa Study: Evaluating QoL After Rectal Cancer Surgery
Recruiting NCT04495088 - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer Phase 3
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Not yet recruiting NCT03520088 - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS N/A
Recruiting NCT04749381 - The Role of TCM on ERAS of Rectal Cancer Patients Phase 2
Recruiting NCT03283540 - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Recruiting NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Suspended NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT04936581 - Patient Reported Outcomes Following Cancer of the Rectum
Not yet recruiting NCT04966819 - Rectal Cancer Shared Care N/A
Active, not recruiting NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Terminated NCT02933944 - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer Phase 1
Active, not recruiting NCT02438839 - Curative Chemoradiation of Low Rectal Cancer
Completed NCT02626728 - A Prospective Feasibility Study for TAMIS N/A
Completed NCT02399813 - Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Phase 2
Recruiting NCT02592304 - Preoperative Assessment of Mesorectal Lymph Nodes by Dual Energy CT. PUMK-DECT N/A
Completed NCT02243267 - GI SPORE Colon Biosample Protocol N/A