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NCT07742969
The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes
Conditions: Breast Cancer, Caregiver, Caregiver Anxiety, Self Care, Dyadic Intervention, Education, Caregiver Burden
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 156
Sponsor: Ulviye Aydan NACAK
Summary
This randomized controlled trial aims to evaluate the effect of dyadic self-care education provided to breast cancer patient-caregiver dyads receiving outpatient chemotherapy on patient self-care behaviors, anxiety levels, and caregiver anxiety levels and caregiver burden. Participants will be randomly assigned to either a dyadic self-care education intervention or routine care. Outcomes will be assessed at baseline and follow-up using validated instruments.
Eligibility Criteria
Inclusion Criteria:
Patients:
* Female patients aged 18 years or older.
* Diagnosed with stage II or III breast cancer.
* Aware of their breast cancer diagnosis.
* Receiving outpatient chemotherapy after mastectomy.
* Having received at least one cycle of an EC (epirubicin-cyclophosphamide) or AC (doxorubicin-cyclophosphamide) chemotherapy regimen.
* Able to read and write Turkish.
* Having a primary caregiver who is willing to participate in the study.
* Living with the primary caregiver.
* Conscious, able to communicate effectively, and able to provide informed consent.
* No diagnosed psychiatric disorder.
Primary Caregivers:
* Aged 18 years or older.
* Able to read and write Turkish.
* Living with the patient.
* Being the patient's spouse, parent, child, friend, or another relative.
* Assuming the main responsibility for the patient's care.
* Willing and able to cooperate and provide informed consent.
* No diagnosed psychiatric disorder.
Exclusion Criteria:
Patients:
* Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
* Admission to an intensive care unit during the study.
* Progression of the disease to stage IV breast cancer.
* Death or loss to follow-up.
Primary Caregivers:
* Having experienced a major adverse life event within the previous 3 months, such as bereavement or divorce.
* Deterioration in health that prevents continued participation.
* Transfer of the primary caregiving responsibility to another person.
Source: ClinicalTrials.gov (NCT07742969). StuddyBuddy aggregates publicly available trial information.