Clinical trial · Observational
The Development of a Patient Reported Outcomes Measure Committed to the Watch-and-wait Program for Rectal Cancer
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
NCT05040646CI-TRIAL-00064743completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delphi exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Patients who follow the watch-and-wait program for rectal cancer.
- interventionNames
- Other: Delphi exercise
- label
- Experts
- description
- Surgeons, radiotherapists, medical oncologist and other medical personnel who are involved in the treatment of rectal cancer and the watch-and-wait program.
- interventionNames
- Other: Delphi exercise
Primary outcomes (2)
- measure
- Consensus in / Important outcome
- timeFrame
- between 3 months and 5 years of follow up
- description
- \>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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDGreenhalgh 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
- BACKGROUNDIshaque 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
- BACKGROUNDBlack N. Patient reported outcome measures could help transform healthcare. BMJ. 2013 Jan 28;346:f167. doi: 10.1136/bmj.f167. PMID 23358487
- BACKGROUNDEdwards 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
- BACKGROUNDMaas 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
- BACKGROUNDvan 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
- 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.