The Person-centered Evolution of Radiotherapy Services in Ontario Study

NCT04507568 | Active Not Recruiting

• 1 other identifier: 20-5111
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, prospective, investigator initiated, randomized controlled study of patients with breast cancer who will be receiving radiation therapy as per SOC. Patients will be randomized in either the person-centered model-of-care versus the standard model of care. Patients randomized to the person-centered model-of-care will have a 30 minute education session with a radiation therapist in addition to RT SOC procedures. Patients randomized to the standard model of care will be treated as per SOC. Questionnaires will be administered to both arms at baseline, and at the first and last day of treatment. In addition to the main study, patients will have the option to participate in a semi-structured one on one interview upon completion of their radiotherapy course.

Conditions

Breast Cancer; Quality of Life

Keywords

Radiation Therapy; Patient Experience; Anxiety Levels

Outcome Measures

Primary Outcomes (1)

• Patient Anxiety Levels

  Hospital Anxiety and Depression Scale (HADS) questionnaire

  Up to 5 weeks.

Secondary Outcomes (5)

• Patient-reported self-efficacy

  Up to 5 weeks.

• Patient-reported engagement level

  Up to 5 weeks.

• Patient-reported experience

  Up to 5 weeks.

• Patient-reported experience

  Up to 5 weeks.

• Patient-reported preparedness for radiation therapy

  Up to 5 weeks.

Study Arms (2)

Person-Centered Model-of-Care

EXPERIMENTAL

Patients randomized to the person-centered model-of-care will have a 30 minute education session with a radiation therapist in addition to the standard of care, radiation therapy procedures.

Other: Quality of Life Questionnaires

Standard Model-of-Care

OTHER

Patients randomized to the standard model of care will be treated as per standard of care.

Other: Quality of Life Questionnaires

Interventions

Quality of Life Questionnaires OTHER

Quality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment.

Person-Centered Model-of-Care; Standard Model-of-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Diagnosis of non-metastatic breast cancer
• Intended to receive radiation therapy to the breast/chest-wall and regional lymph nodes
• Ability to communicate in English without assistance of another person
• Ability to provide informed consent

You may not qualify if:

• Commenced any radiation therapy-specific procedures (e.g. education, CT-simulation, etc.)
• Received a previous course of radiation therapy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 11, 2020
• Study Start: August 13, 2020
• Primary Completion: March 24, 2022
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)