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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Caregiver Caregiver Anxiety Caregiver Burden Dyadic Intervention Education Mental Disorders Neoplasms Neoplasms by Site Self Care Skin Diseases Skin and Connective Tissue Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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 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.
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.

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.
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 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.
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.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ulviye Aydan NACAK, RN, MSc

CONTACT

[email protected]

+905077421627

Sponsors and collaborators

Lead sponsor

Ulviye Aydan NACAK

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 3, 2026
Registry last updated: Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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