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

109 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Person-centered model-of-care for improving quality of life?

Research shows that patient-centered care, which includes understanding and incorporating patient-reported outcomes, can enhance the quality of life by aligning medical treatments with patients' personal experiences and preferences. This approach helps ensure that care is tailored to individual needs, potentially leading to better health outcomes. ^{1 2 3 4 5}

Is person-centered care generally safe for humans?

Person-centered care, which focuses on involving patients in their own healthcare decisions, is generally considered safe and can enhance patient safety by preventing or reducing adverse events (unwanted or harmful outcomes). It emphasizes communication, trust, and collaboration between patients and healthcare providers, which can lead to improved safety and quality of care. ^{6 7 8 9 10}

How is the person-centered care treatment different from other treatments for improving quality of life?

Person-centered care is unique because it focuses on the individual needs and preferences of the patient, building care around their personal experiences and relationships. Unlike traditional treatments that may follow a one-size-fits-all approach, this model emphasizes understanding and respecting each person's unique situation to enhance their quality of life. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Practice What We Preach: Beginning a Journey to Embrace Patient-Centered Outcomes Research. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Incorporating Patient-Reported Outcomes Into Health Care To Engage Patients And Enhance Care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Montreal Accord on Patient-Reported Outcomes (PROs) use series-Paper 7: modern perspectives of measurement validation emphasize justification of inferences based on patient reported outcome scores. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Gynecologic Surgical Outcomes Through the Patient's Eyes: Are Physicians Looking in the Same Direction? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-reported Outcome Measures - A Call for More Narrative Evidence. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A framework to assess patient-reported adverse outcomes arising during hospitalization. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review of patient-engagement interventions: potentials for enhancing person-centred care for older patients with multimorbidity. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient safety: a consumer's perspective. [2011]

10. England 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. [2023]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Persian language person-centered climate questionnaire - Patient version (PCQ-P). [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Does Person-Centered Care Improve Residents' Satisfaction With Nursing Home Quality? [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The Fundamentals of Person-Centered Care for Individuals With Dementia. [2022]

15. England pubmed.ncbi.nlm.nih.gov

A national research centre for the evaluation and implementation of person-centred care: Content from the first interventional studies. [2021]