Breast Cancer, Caregiver, Caregiver Anxiety, Caregiver Burden, Dyadic Intervention, Education, Self Care
Conditions
Keywords
breast cancer, dyadic self care, education, self care behaviour, anxiety, 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.
Interventions
BEHAVIORALDyadic 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 conducted at baseline, immediately after the four-week intervention, and at a one-month follow-up.
Sponsors
Ulviye Aydan NACAK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Self-Care Behavior | 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 | 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 | 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 | 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. |
Contacts
CONTACTUlviye Aydan NACAK, RN, MSc
PRINCIPAL_INVESTIGATORMağfiret Kaşıkçı, Professor, PhD
Atatürk University, Faculty of Nursing
Outcome results
None listed