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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Other: Delphi exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who follow the watch-and-wait program for rectal cancer. | Other: Delphi exercise<br>* 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.<br>|
| Experts<br>Surgeons, radiotherapists, medical oncologist and other medical personnel who are involved in the treatment of rectal cancer and the watch-and-wait program. | Other: Delphi exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consensus in / Important outcome | >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 | between 3 months and 5 years of follow up | 
| Consensus in / No important outcome | <70% of the clinicians and (clinical) researchers rating the outcome '7-9' AND an average patient rating of <7 | between 3 months and 5 years of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Watch-and-wait, Organ-preserving treatment method, Functional outcomes, Patient reported outcome measures, Quality of life, Delphi exercise