Rectal Cancer
Conditions
Keywords
Watch-and-wait, Organ-preserving treatment method, Functional outcomes, Patient reported outcome measures, Quality of life, Delphi exercise
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.
Interventions
OTHERDelphi 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.
Sponsors
Maastricht University Medical Center
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed