Clinical trial NCT04925154: Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.
Official title: PATHOS Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Preference
Keywords: Colorectal cancer
Treatment preferences
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will evaluate 192 participants:

* 14 physicians (group A)
* 178 patients (group B)

Brief summary: This study is aiming to look into patients' treatment preferences and their socio economic background as well as the exploration of thought processes leading to these preferences. It will integrate, in two exploratory questionnaires, the three most common treatment schema (standard of care, non-operative management, surgery alone) all of which have been demonstrated efficacious.

Detailed description: The primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. The secondary objective is to assess the tradeoff level between the benefits versus quality of life.

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).

Eligibility criteria: Inclusion Criteria:

Group A

* 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:

Group A:

* 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

Primary outcomes:
measure: Socio-economic and demographic characteristics
timeFrame: 1 day
Secondary outcomes:
measure: Tradeoff level
timeFrame: 1 day
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute - JGH
name: Té Vuong
role: PRINCIPAL_INVESTIGATOR
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