Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.
NCT ID: NCT04925154
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
192 participants
OBSERVATIONAL
2021-12-13
2026-01-01
Brief Summary
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Detailed Description
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This study will evaluate 192 participants: 14 physicians (group A) and 178 patients (group B).
Participants with operable rectal cancer or health professionals will be screened for eligibility. Subsequently, these participants will be offered to participate in this pilot study and provided a consent form. When a participant has consented to participate, he/she will be provided with a first questionnaire (socio-demographic characteristics, some clinical data and medical baseline information as well as details about their current knowledge about treatments).
An informational brochure will be given after answering the first questionnaire describing different treatment regimens, treatment duration, potential side effects and oncologic outcomes.
A second questionnaire will be provided (evaluating patients treatment preferences and tradeoff).
The consent form, brochure and questionnaires will be available only in an electronic format (Microsoft Form).
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Group A: Patients
Recruitment for this group will take place at either the radiation-oncology department or at the colorectal surgery department, at the time of consultation or at the time of diagnosis, before the treatment setting. Once clinical staging is available, the surgeon and/or radiation-oncologist and/or research assistant should identify eligible patients. Patients that comply with selection criteria (inclusion/exclusion) will be approached by a research team member. For those patients interested in participating, the e-link to the consent form for this group will be sent by email. Once a patient decides to sign the consent form, the link for the questionnaire Q1 will be sent by email.
The only intervention will be the information brochure that will be given after the first questionnaire.
The information brochure will be given to both groups at the same time at 2-3 weeks after the first consultation (patients group) or after answering the first questionnaire (physicians group).
Group B: Physicians
Health professionals will be approached by the research team. The study aim will be explained, and participants that agree to participate will be provided an e-link to consent for this group. Once the health care participant decides to sign the consent form, the link for the questionnaire Q1 will be sent by email.
The only intervention will be the information brochure that will be given after the first questionnaire.
The information brochure will be given to both groups at the same time at 2-3 weeks after the first consultation (patients group) or after answering the first questionnaire (physicians group).
Interventions
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The only intervention will be the information brochure that will be given after the first questionnaire.
The information brochure will be given to both groups at the same time at 2-3 weeks after the first consultation (patients group) or after answering the first questionnaire (physicians group).
Eligibility Criteria
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Inclusion Criteria
* New rectal cancer patient
* Operable patients
* Capable adults older than 18 years of age
* Capacity to sign a consent form
* Capacity to answer questionnaires on an online platform Group B
* Treating physician specialists
* Capacity to sign a consent form
* Capacity to answer questionnaires on an online platform
Exclusion Criteria
* Patient unable to sign a consent form
* Patients with metastasis
* Recurrent tumours
* Inability to answer questionnaires on an online platform
* Inability to communicate in french or english
Group B:
* Participant unable to sign a consent form
* Inability to answer questionnaires on an online platform
18 Years
ALL
Yes
Sponsors
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Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
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Dr. Te Vuong
Radiation-oncologist
Principal Investigators
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Té Vuong
Role: PRINCIPAL_INVESTIGATOR
Lady Davis Institute - JGH
Locations
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Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2021-2517
Identifier Type: -
Identifier Source: org_study_id
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