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Not yet recruiting NCT07742969

The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes

No phase Interventional Breast Cancer Caregiver Caregiver Anxiety Self Care

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗