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

NCT04925154 | Recruiting

• 1 other identifier: 2021-2517
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Preference

Keywords

Colorectal cancer; Treatment preferences

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tradeoff level

  1 day

Study Arms (2)

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.

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.

Interventions

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).

Group A: Patients; Group B: Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will evaluate 192 participants: * 14 physicians (group A) * 178 patients (group B)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Patient Preference; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Té Vuong

  Lady Davis Institute - JGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Starr, BHSc

CONTACT

514-340-8222; emma.starr.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation-oncologist

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: December 13, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (1)