NCT05040646

The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer

Study Protocol - The Development of a Novel Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer: An International Delphi Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
OTHER	Delphi exercise	During the Delphi exercise both patients and experts will participate in two anonymous online survey rounds where different items/outcomes will be presented that are possibly related to rectal cancer and the W\&W program. Both groups are asked to rate each item on a 9 point likert scale with respect to the importancy of the item. After the two subsequent rounds, participants will be invited to attend a consensus meeting, where final consensus about the most important outcomes will be reached.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-04-01
• Completion: 2023-03-15
• First posted: 2021-09-10
• Last updated: 2023-03-16

Locations

1 site across 1 country: Netherlands