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

Completed

• Conditions: Rectal Cancer
• Interventions: Other: Delphi exercise

• Registration Number: NCT05040646
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-10
• Study Start: 2021-11-01
• Primary Completion: 2022-04-01
• Last Update Submitted: 2023-03-14
• Study Completion: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients have to be treated with neoadjuvant (chemo)radiotherapy
• Patients are included into the Watch-and-Wait program
• Experts involved in the treatment of rectal cancer
• Experts involved in the Watch-and-Wait program

Exclusion Criteria

• Regrowth of disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Delphi exercise	Patients who follow the watch-and-wait program for rectal cancer.
Experts	Delphi exercise	Surgeons, radiotherapists, medical oncologist and other medical personnel who are involved in the treatment of rectal cancer and the watch-and-wait program.

Primary Outcome Measures

Name	Time	Method
Consensus in / Important outcome	between 3 months and 5 years of follow up	\>70% of the participants in each panel rating the outcome '7-9' OR \<70% of the clinicians and (clinical) researchers rating the outcome '7-9' but an average patient rating of \>7
Consensus in / No important outcome	between 3 months and 5 years of follow up	\<70% of the clinicians and (clinical) researchers rating the outcome '7-9' AND an average patient rating of \<7

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Limburg, Netherlands