Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Quality of Life
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. A...

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.

Tracking Information

NCT #
NCT04507568
Collaborators
Not Provided
Investigators
Not Provided