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

NCT05040646 | Completed

• 1 other identifier: 2021-2805
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Cancer

Keywords

Watch-and-wait; Organ-preserving treatment method; Functional outcomes; Patient reported outcome measures; Quality of life; Delphi exercise

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients

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

Other: Delphi exercise

Experts

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

Interventions

Delphi exercise 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; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Regrowth of disease

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (8)

• 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.

  PMID: 30294712 BACKGROUND

• 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.

  PMID: 30284183 BACKGROUND

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

  PMID: 23358487 BACKGROUND

• 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.

  PMID: 12016181 BACKGROUND

• 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.

  PMID: 22067400 BACKGROUND

• 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.

  PMID: 29976470 BACKGROUND

• 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.

  PMID: 31188180 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Stéphanie Breukink, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: September 10, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: March 15, 2023
• Last Updated: March 16, 2023

Record last verified: 2021-06

Locations

NL (1)