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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040646
• Other study ID #: 2021-2805
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 15, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167. — View Citation

Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. Increasing response rates to postal questionnaires: systematic review. BMJ. 2002 May 18;324(7347):1183. doi: 10.1136/bmj.324.7347.1183. — View Citation

Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J, Valderas J, Black N. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018 Sep 15;2:42. doi: 10.1186/s41687-018-0061-6. eCollection 2018 Dec. — View Citation

Habr-Gama A, Sao Juliao GP, Fernandez LM, Vailati BB, Andrade A, Araujo SEA, Gama-Rodrigues J, Perez RO. Achieving a Complete Clinical Response After Neoadjuvant Chemoradiation That Does Not Require Surgical Resection: It May Take Longer Than You Think! Dis Colon Rectum. 2019 Jul;62(7):802-808. doi: 10.1097/DCR.0000000000001338. — View Citation

Hsu, C. and B. Sandford, The Delphi technique: making sense of consensus-Practical assessment, research & evaluation. Pract Assessment. Res Eval, 2007. 12.

Ishaque S, Karnon J, Chen G, Nair R, Salter AB. A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs). Qual Life Res. 2019 Mar;28(3):567-592. doi: 10.1007/s11136-018-2016-z. Epub 2018 Oct 3. — View Citation

Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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