The Effect of Dyadic Self-Care Education Provided to Breast Cancer Patient-Caregiver Dyads on Patient and Caregiver Outcomes | NCT07742969

NCT07742969

Overview

NCT ID: NCT07742969
Lead Sponsor: Ulviye Aydan NACAKOTHER
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
Brief 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.
Conditions: Breast Cancer
Caregiver
Caregiver Anxiety
Self Care
Dyadic Intervention

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Oct 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 156Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Ulviye Aydan NACAK, RN, MScContact
aydannacak42@gmail.com+905077421627

Similar Studies

Participant Group/Arms

Dyadic self care educationExperimental

A structured dyadic self-care education program will be provided to 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. The intervention consists of four weekly face-to-face education sessions focusing on symptom management, self-care behaviors, and collaborative patient-caregiver participation in care. Outcomes will be assessed at baseline, immediately after completion of the four-week intervention (post-test), and one month after the post-intervention assessment (follow-up).

Behavioral: Dyadic Self Care Education

Routine Care ControlNo Intervention

The control arm will include 39 dyads. Each dyad consists of one breast cancer patient receiving chemotherapy and one primary caregiver. Participants will receive routine nursing care provided by the clinic and will not receive the dyadic self-care education program. Outcomes will be assessed at baseline, after four weeks, and at a one-month follow-up after the post-intervention assessment.