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

NCT07742969 | Not Yet Recruiting

• 2 other identifiers: AU-BC-DYAD-26SDK-2026-17003
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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; Education; Caregiver Burden

Keywords

breast cancer; dyadic self care; education; self care behaviour; anxiety; caregiver burden

Outcome Measures

Primary Outcomes (4)

• Patient Self-Care Behavior

  Patient self-care behavior will be assessed using the Self-Care Behaviors Scale Based on the Self-Care Deficit Nursing Theory for Patients Receiving Chemotherapy. The scale consists of 24 items rated on a 5-point Likert scale from 1 (never) to 5 (always). Items 11, 20, and 23 are reverse scored. Total scores range from 24 to 120, with higher scores indicating better self-care behaviors. The scale includes six subdimensions: personal care, sleep pattern, maintenance of respiration, activity and mobility, nutritional habits, and coping with problems.

  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

  Patient anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.

  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

  Caregiver anxiety will be assessed using the Beck Anxiety Inventory (BAI). The inventory consists of 21 items rated on a 4-point Likert scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are interpreted as follows: 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety.

  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

  Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). The scale consists of 22 items rated from 0 (never) to 4 (always). There are no reverse-scored items. Total scores range from 0 to 88, with higher scores indicating greater perceived caregiver burden. Scores are interpreted as follows: below 21, no burden; 21-40, mild burden; 41-60, moderate burden; and 61-88, severe burden.

  Baseline (pre-intervention), immediately after completion of the 4-week intervention, and 1 month after completion of the intervention.

Study Arms (2)

Dyadic self care education

EXPERIMENTAL

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 Control

NO 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.

Interventions

Dyadic Self Care Education BEHAVIORAL

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 conducted at baseline, immediately after the four-week intervention, and at a one-month follow-up.

Dyadic self care education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulviye Aydan NACAK: lead

MeSH Terms

Conditions

Breast Neoplasms; Caregiver Burden; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Mağfiret Kaşıkçı, Professor, PhD

  Atatürk University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulviye Aydan NACAK, RN, MSc

CONTACT

+905077421627; aydannacak42@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and the statistician performing the data analysis will be blinded to group allocation. Participants and investigators delivering the intervention will not be blinded because of the nature of the educational intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant, PhD Student, Department of Nursing

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the dyadic self-care education intervention group or the routine care control group. Outcomes will be assessed at baseline and follow-up.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share