Breast CancerPERSONNCT04507568
The Person-centered Evolution of Radiotherapy Services in Ontario Study
A study testing Quality of Life Questionnaires in people with Breast Cancer and Quality of Life, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Quality of Life
- What is being tested?
- Quality of Life Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- 13 Aug 2020to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Commenced any radiation therapy-specific procedures (e.g. education, CT-simulation, etc.)
- Received a previous course of radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Person-centered Evolution of Radiotherapy Services in Ontario (PERSON) Study
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.
Read the detailed description
Radiation therapy plays an integral role in the definitive treatment of breast cancer by reducing the risk of locoregional recurrence and improving patient outcomes. Despite the availability of supportive care services, many patients have unmet needs which may lead to unexpected negative outcomes. Anxiety can affect patients' ability to cope, interfere with treatment and self-manage their own care. Strategies to improve cancer care include patient navigators or case managers, early interventions and self-management of side effects to reduce treatment-related toxicities. Therefore, minimizing distress from treatment and engaging patients by personalizing care according to their unique needs will optimize use of supportive care services and improve clinical outcomes.
A Cochrane review demonstrated that information and supportive care sessions delivered by non-physician healthcare providers improves both emotional wellbeing and quality of life in breast cancer patients. A prospective randomized, Australian study by Halkett et al. demonstrated that an education intervention delivered one-on-one by Radiation Therapists effectively reduces breast cancer patients' psychological distress and improves preparedness for treatment. This highlights the importance of early and accessible education resources where patients experience direct access to the radiation therapy team.
Further research is required to investigate the efficacy of person-centered model on patient experiences and relevant clinical outcomes. Specifically, it is expected this model will reduce patient anxiety, improve preparedness for radiation therapy through education, and improve patient self-management of radiation-toxicities. The proposed study focuses on patients with breast cancer because of the experience in testing the model on this group and their relatively uniform treatment at all Ontario cancer centres, which will facilitate translation of this model in the future. A randomized controlled study will determine the efficacy of the person-centered model versus standard care, and generate high-quality evidence in an unbiased setting that was not possible in the prior clinical pilot phases.
Personalizing patient experiences in radiotherapy, coupled with improvements in treatment quality and supportive care, may improve clinical outcomes including toxicity and quality of life.
- Conditions
- Breast Cancer, Quality of Life
- Being tested
- Quality of Life Questionnaires
- Keywords
- Radiation Therapy, Patient Experience, Anxiety Levels
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnairesOther
Quality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Anxiety Levels
Hospital Anxiety and Depression Scale (HADS) questionnaire
Measured: Up to 5 weeks.
Secondary outcomes (5)
Patient-reported self-efficacy
Patient-Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Survey
Measured: Up to 5 weeks.
Patient-reported engagement level
Patient Health Engagement (PHE) survey
Measured: Up to 5 weeks.
Patient-reported experience
EORTC satisfaction with cancer care core (EORTC PATSAT-C33) questionnaire
Measured: Up to 5 weeks.
Patient-reported experience
Specific complementary outpatient module (EORTC OUT-PATSAT7) questionnaire
Measured: Up to 5 weeks.
Patient-reported preparedness for radiation therapy
Cancer Treatment Survey (CaTS)
Measured: Up to 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start13 Aug 2020
- Primary completion24 Mar 2022
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507568
- Sponsor's protocol ID
- 20-5111
- Acronym
- PERSON
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Person-centered Evolution of Radiotherapy Services in Ontario (PERSON) Study
- ClinicalTrials.gov ID
- NCT04507568
- Acronym / sponsor ID
- PERSON / 20-5111
- Conditions
- Breast Cancer, Quality of Life
- Keywords
- Radiation Therapy, Patient Experience, Anxiety Levels
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiation therapy plays an integral role in the definitive treatment of breast cancer by reducing the risk of locoregional recurrence and improving patient outcomes. Despite the availability of supportive care services, many patients have unmet needs which may lead to unexpected negative outcomes. Anxiety can affect patients' ability to cope, interfere with treatment and self-manage their own care. Strategies to improve cancer care include patient navigators or case managers, early interventions and self-management of side effects to reduce treatment-related toxicities. Therefore, minimizing distress from treatment and engaging patients by personalizing care according to their unique needs will optimize use of supportive care services and improve clinical outcomes.
A Cochrane review demonstrated that information and supportive care sessions delivered by non-physician healthcare providers improves both emotional wellbeing and quality of life in breast cancer patients. A prospective randomized, Australian study by Halkett et al. demonstrated that an education intervention delivered one-on-one by Radiation Therapists effectively reduces breast cancer patients' psychological distress and improves preparedness for treatment. This highlights the importance of early and accessible education resources where patients experience direct access to the radiation therapy team.
Further research is required to investigate the efficacy of person-centered model on patient experiences and relevant clinical outcomes. Specifically, it is expected this model will reduce patient anxiety, improve preparedness for radiation therapy through education, and improve patient self-management of radiation-toxicities. The proposed study focuses on patients with breast cancer because of the experience in testing the model on this group and their relatively uniform treatment at all Ontario cancer centres, which will facilitate translation of this model in the future. A randomized controlled study will determine the efficacy of the person-centered model versus standard care, and generate high-quality evidence in an unbiased setting that was not possible in the prior clinical pilot phases.
Personalizing patient experiences in radiotherapy, coupled with improvements in treatment quality and supportive care, may improve clinical outcomes including toxicity and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-Centered Model-of-Care | Experimental | Other: Quality of Life QuestionnairesPatients 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. |
| Standard Model-of-Care | Other | Other: Quality of Life QuestionnairesPatients randomized to the standard model of care will be treated as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Commenced any radiation therapy-specific procedures (e.g. education, CT-simulation, etc.)
- Received a previous course of radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life QuestionnairesQuality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment. | Other | Person-Centered Model-of-Care, Standard Model-of-Care |
Primary outcome
Patient Anxiety Levels
Time frame: Up to 5 weeks.
Hospital Anxiety and Depression Scale (HADS) questionnaire
5 secondary outcomes
Patient-reported self-efficacy
Time frame: Up to 5 weeks.
Patient-reported engagement level
Time frame: Up to 5 weeks.
Patient-reported experience
Time frame: Up to 5 weeks.
Patient-reported experience
Time frame: Up to 5 weeks.
Patient-reported preparedness for radiation therapy
Time frame: Up to 5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Questionnaires in people with Breast Cancer and Quality of Life, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Anxiety Levels (time frame: Up to 5 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.