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

March 19, 2024 updated by: Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will evaluate 192 participants:

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Patients
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.
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).
Group B: Physicians
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-economic and demographic characteristics
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tradeoff level
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

  • Principal Investigator: Té Vuong, Lady Davis Institute - JGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-2517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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