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

Recruiting

• Conditions: Patient Preference

• Registration Number: NCT04925154
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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).

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-14
• Study Start: 2021-12-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Socio-economic and demographic characteristics	1 day	The 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 Outcome Measures

Name	Time	Method
Tradeoff level	1 day	The 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.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada