NCT04925154

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 192 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Patient Preference

Interventions

Type	Name	Description
BEHAVIORAL	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).

Timeline

• Start date: 2021-12-13
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2021-06-14
• Last updated: 2024-03-20

Locations

1 site across 1 country: Canada