Clinical trial NCT05040646: The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Watch-and-wait
Organ-preserving treatment method
Functional outcomes
Patient reported outcome measures
Quality of life
Delphi exercise
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of both patients and experts (surgeons, radiotherapist, medical oncologist and other medical personnel) who are involved in the watch-and-wait program for rectal cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Consensus in / Important outcome
timeFrame: between 3 months and 5 years of follow up
measure: Consensus in / No important outcome
timeFrame: between 3 months and 5 years of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Stéphanie Breukink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: van der Valk MJM, Hilling DE, Bastiaannet E, Meershoek-Klein Kranenbarg E, Beets GL, Figueiredo NL, Habr-Gama A, Perez RO, Renehan AG, van de Velde CJH; IWWD Consortium. Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study. Lancet. 2018 Jun 23;391(10139):2537-2545. doi: 10.1016/S0140-6736(18)31078-X.
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