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NCT Number: NCT04925154

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location status: Recruiting

Location contact

Té Vuong, MD

CONTACT

[email protected]

514-340-8222 ext. 22073

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Starr, BHSc

CONTACT

[email protected]

514-340-8222 ext. 28443

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

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

Acronym: Pathos

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jun 14, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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