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Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.

PATHOS Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04925154
Acronym
Pathos
Enrollment
192
Registered
2021-06-14
Start date
2021-12-13
Completion date
2028-01-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Preference

Keywords

Colorectal cancer, Treatment preferences

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).

Interventions

BEHAVIORALThe 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).

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Socio-economic and demographic characteristics1 dayThe primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. This will be evaluated with the first questionnaire given at the time of the first consultation or when first approached by a research team member.

Secondary

MeasureTime frameDescription
Tradeoff level1 dayThe second objective is to assess the tradeoff level between the benefits versus quality of life. This will be evaluated with the second questionnaire given 2-3 weeks after the first consultation or after answering the first questionnaire.

Countries

Canada

Contacts

CONTACTEmma Starr, BHSc
emma.starr.ccomtl@ssss.gouv.qc.ca514-340-8222
PRINCIPAL_INVESTIGATORTé Vuong

Lady Davis Institute - JGH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026