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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Patient Self-Care Behavior
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Self-Care Behavior
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ulviye Aydan NACAK
Research Assistant, PhD Student, Department of Nursing
Ataturk University