Person-Centered Care for Improving Quality of Life

Overseen By Anne Koch, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Previous radiation therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a person-centered approach (person-centered model-of-care) can improve the quality of life for breast cancer patients undergoing radiation therapy. Participants will either attend a 30-minute education session with a radiation therapist or receive the usual care. The study will compare these two groups to assess whether the additional support makes a difference. It is open to individuals with non-metastatic breast cancer who plan to start radiation therapy. Participants must communicate in English and have not yet begun any radiation therapy procedures. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance patient care and support during radiation therapy.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the person-centered model-of-care is safe?

Research shows that person-centered care, like the approach tested in this trial, is generally safe. Studies have found that this method can enhance emotional well-being and increase patient satisfaction. No major safety concerns exist with person-centered care, as it primarily involves providing additional education and support. This care focuses on individual patient needs and preferences, aiming to improve the overall healthcare experience without altering the medical treatment itself. Consequently, it is well-tolerated and considered safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the person-centered model-of-care because it aims to enhance patients' quality of life during radiation therapy. Unlike the standard approach, which strictly focuses on administering radiation, this model includes a 30-minute educational session with a radiation therapist. This interactive session is designed to empower patients by increasing their understanding of the treatment process, potentially reducing anxiety and improving overall satisfaction. By integrating personalized education, this approach could lead to a more holistic treatment experience for patients undergoing radiation therapy.

What evidence suggests that the person-centered model-of-care could improve quality of life for breast cancer patients receiving radiation therapy?

Research has shown that person-centered care can enhance patients' emotional well-being and satisfaction. In this trial, participants in the person-centered model-of-care arm will receive a 30-minute education session with a radiation therapist, in addition to standard radiation therapy procedures. Studies have found that this type of care often empowers patients and involves them more in their treatment choices. This approach is also cost-effective, providing good value for the benefits it offers. Patients frequently report feeling respected and well-informed, which enhances their overall experience. Overall, evidence suggests that person-centered care can lead to better outcomes compared to standard care practices. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-metastatic breast cancer who speak English and can consent to treatment. They should be set to receive radiation therapy but haven't started any specific procedures or received previous radiation.

Inclusion Criteria

Ability to communicate in English without assistance of another person

I am planning to undergo radiation therapy for my breast cancer.

My breast cancer has not spread to other parts of my body.

Exclusion Criteria

I have started preparations for radiation therapy.

I have undergone radiation therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy as per standard of care, with an additional 30-minute education session for those in the person-centered model

5 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for patient-reported outcomes such as anxiety levels, engagement, and preparedness for radiation therapy

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Person-centered model-of-care

Trial Overview The study compares a person-centered model of care, which includes an extra education session, against the standard care during radiation therapy. Participants will answer quality of life questionnaires at different stages.

How Is the Trial Designed?

Group I: Standard Model-of-Care Experimental Treatment 1 Intervention

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

Group II: Person-Centered Model-of-Care Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

A consensus workshop with 31 healthcare professionals identified and ranked common adverse events in community care, highlighting the need for better understanding of how these events affect care quality.

The workshop emphasized the importance of further research to establish standardized definitions of adverse events and to prioritize research questions that can improve patient safety in community care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. Masotti, P., Green, M., Shortt, S., et al.[2022]

In a study involving 1329 patients from primary care settings in Australia and England, 5.3% reported safety incidents over the past year, with the most common issues being delays in accessing care and problems with diagnosis and assessment.

The study highlighted that patient-reported incidents often differ from those reported by staff, underscoring the importance of including patient perspectives to improve safety and service quality in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. Hernan, AL., Giles, SJ., Carson-Stevens, A., et al.[2023]

Citations

1. cms.gov cms.gov/priorities/innovation/key-concepts/person-centered-care

Person-Centered Care In a value-based health care system, doctors and other health care providers deliver high-quality care using a person-centered care approach.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098301525022831

Costs and Health Outcomes in Economic Evaluations of ... This study shows that person-centered care interventions are generally neutral, cost-effective, or cost saving, compared with care as usual.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453984/

Person-centred care and its outcomes in primary care ... Person-centred care (PCC) has been associated with many positive outcomes of care: patients' emotional state, satisfaction and empowerment, medication ...

4. gh.bmj.com gh.bmj.com/content/5/12/e003330

The empirical evidence underpinning the concept and ... The findings suggest that person-centred care encompasses the patient and family being respected, given complete information, involved in decision-making and ...

5. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2025.1578037/pdf

Time is now to consider how we evaluate person-centred ... An increasing body of research has found person-centred care associated with many positive outcomes. For example, patients reported improved ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10620693/

More patient-centered care, better healthcare The objective of this study is to explore the association between patient-centered care (PCC) and inpatient healthcare outcomes.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748919300537

Person-centered rehabilitation care and outcomes It appears that person-centered care could positively affect rehabilitation outcomes, such as significant improvements in functional performance and quality of ...

8. ahrq.gov ahrq.gov/talkingquality/measures/six-domains.html

Six Domains of Healthcare Quality Patient-centered: Providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values ...