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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-03-15

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

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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.

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients

Patients who follow the watch-and-wait program for rectal cancer.

Delphi exercise

Intervention Type OTHER

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.

Experts

Surgeons, radiotherapists, medical oncologist and other medical personnel who are involved in the treatment of rectal cancer and the watch-and-wait program.

Delphi exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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