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Rectal CancerNCT05040646

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

An observational study of Rectal Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Delphi exercise
How many people
80 participants
Where
1 siteNetherlands
Study dates
1 Nov 2021to 15 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Regrowth of disease

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht UMC

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

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

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

Read the 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.

Conditions
Rectal Cancer
Being tested
Delphi exercise
Keywords
Watch-and-wait, Organ-preserving treatment method, Functional outcomes, Patient reported outcome measures, Quality of life, Delphi exercise
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delphi exerciseOther

    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.

Study groups in NCT05040646
Study groupRoleWhat they receive
PatientsPatients who follow the watch-and-wait program for rectal cancer.
Receives: Other: Delphi exercise
ExpertsSurgeons, radiotherapists, medical oncologist and other medical personnel who are involved in the treatment of rectal cancer and the watch-and-wait program.
Receives: Other: Delphi exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: between 3 months and 5 years of follow up

  2. Consensus in / No important outcome

    <70% of the clinicians and (clinical) researchers rating the outcome '7-9' AND an average patient rating of <7

    Measured: between 3 months and 5 years of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start1 Nov 2021
  3. Primary completion1 Apr 2022
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040646
Sponsor's protocol ID
2021-2805
Status last verified
Jun 2021
First submitted
29 Jun 2021
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30294712

  • 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.

    PubMed 30284183

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

    PubMed 23358487

  • 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.

    PubMed 12016181

  • 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.

    PubMed 22067400

  • 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.

    PubMed 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.

    PubMed 31188180

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

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consensus in / Important outcome (time frame: between 3 months and 5 years of follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05040646, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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