The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dyadic Self Care Education.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Caregiver, Caregiver Anxiety, Self Care. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes: Self-Care Behavior, Anxiety Level, and Caregiver Burden
Overview
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.
Interventions
- Behavioral Dyadic Self Care Education
A structured dyadic self-care education program for breast cancer patient-primary caregiver dyads receiving outpatient chemotherapy. One patient and one primary caregiver constitute one dyad. The intervention includes four weekly face-to-face education sessions focusing on the management of chemotherapy-related side effects, self-care maintenance, symptom monitoring, infection prevention, nutrition, fatigue, oral care, skin care, medication adherence, and caregiver support. Assessments will be c
Primary outcome measures
- Patient Self-Care Behavior [Time frame: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
- Patient Anxiety Assessed by the Beck Anxiety Inventory [Time frame: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
- Caregiver Anxiety Assessed by the Beck Anxiety Inventory [Time frame: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
- Caregiver Burden Assessed by the Zarit Burden Interview [Time frame: Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07742969 · AU-BC-DYAD-26 · SDK-2026-17003