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

Sir Mortimer B. Davis - Jewish General Hospital

Status: Enrolling

Conditions: Patient Preference

Treatments: Behavioral: The only intervention will be the information brochure that will be given after the first questionnaire.

Study type: Observational

Funder types: Other

Identifiers

NCT04925154

2021-2517

Details and patient eligibility

About

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.

Full 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).

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

192 participants in 2 patient groups

Group A: Patients

Description:

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.

Treatment:

Behavioral: The only intervention will be the information brochure that will be given after the first questionnaire.

Group B: Physicians

Description:

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.

Treatment:

Behavioral: The only intervention will be the information brochure that will be given after the first questionnaire.