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.
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 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.
Parallel
Dyadic Self Care Education
BehavioralA 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.
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.
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.
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.
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.
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Ulviye Aydan NACAK
Lead sponsor
Ataturk University
Sponsor institution
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