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

Patient Preference Clinical Trial

— Pathos  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925154
• Other study ID #: 2021-2517
• Status: Recruiting
• Start date: December 13, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Emma Starr, BHSc
• Phone: 514-340-8222
• Email: emma.starr.ccomtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Preference

Intervention

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).

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Socio-economic and demographic characteristics	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	Tradeoff level	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