Effects of Health Belief Model Based Nursing Interventions Offered at Home Visits on Lymphedema Prevention in Women With Breast Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Quick-Disabilities of the Arm, Shoulder and Hand Score
研究概览
简要总结
Aim: The study was performed to examine effects of Health Belief Model based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery.
Methods: The study had an experimental design. 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The study had an experimental design. Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at three-month intervals.
Hypotheses of the study
- Extremity function restrictions will be lower in the intervention group than in the control group.
- Self-efficacy levels will be higher in the intervention group than in the control group.
- Functions improving the quality of life will be higher in the intervention group than in the control group.
- There will be fewer symptoms reducing the quality of life in the intervention group than in the control group.
- The incidence of lymphedema will be lower in the intervention group than in the control group.
- The mean cost of the intervention group at home visits, will be lower than in the control group.
What does this paper contribute?
- Nurses can play an effective role in enabling women undergoing breast surgery to acquire behavior of lymphedema prevention. This may reduce treatment costs.
- Future research should evaluate collaborative models of care in general practice aimed at improving lymphedema prevention for women undergoing breast surgery.
- Policymakers should consider introducing funding measures for breast cancer survivors by nurses.
详细描述
Aim of the study The aim of this study was to examine effects of Health Belief Model (HBM) based nursing interventions offered at home visits on lymphedema development in women undergoing breast surgery.
Study design and setting The study had a single-blind, randomized controlled experimental design. To avoid bias, the participants were not told whether they were in the experimental or the control group. The conceptual structure of the study is given. This randomized clinical trial was based on the guidelines proposed by the Consolidated Standard of Reporting Trials - CONSORT 2010. The study was conducted at homes of patients receiving treatment for breast cancer at a hospital and living in Samsun, a city in northern part of Turkey, between May 2016 and April 2017.
Randomization An intervention group and a control group were formed by using the research randomizer software. The program used random numbers to select participants and randomly assign them to the experimental or control group (100 participants were assigned to each group). Homogeneity test showed no significant difference between the measures of the groups in Table 1 (p>.05).
Blinding of data collectors and the statistician was implemented in this randomized blinded study. Another researcher who did not know the group assignments coded the data in the computer. After statistical analysis was conducted and the research report was written, the assistant researcher explained the codes for the experimental and control group. Therefore, blinding of data collectors, statistical analysis, and report writing was provided.
Study outcomes Personal Information Questionnaire;The questionnaire, developed by the researchers, is composed of 17 questions about sociodemographic characteristics, diagnosis and treatment of breast cancer, behavior of lymphedema prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The study had a single-blind, randomized controlled experimental design. To avoid bias, the participants were not told whether they were in the experimental or the control group.
入排标准
- 年龄范围
- 28 Years 至 77 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary breast cancer and having stage I, II and III
- •Having axillary dissection
- •Not having the diagnosis of lymphedema
- •Receiving radiotherapy
- •Volunteering to participate in the study
- •Age over 18 years
- •Residing in the city
排除标准
- •Diagnosis of bilateral breast cancer
- •Open wound or infection in the upper extremities
- •Musculoskeletal disorders preventing movements of the upper extremities
- •Ongoing adjuvant systemic chemotherapy
结局指标
主要结局
Quick-Disabilities of the Arm, Shoulder and Hand Score
时间窗: 6 months
Quick-Disabilities of the Arm, Shoulder and Hand Score;Q-DASH is used to determine severities of disabilities in the upper extremities and benefits gained from treatment. It was adapted Turkish by Duger et al. and its cronbach's alpha was reported to be .91. It is a five-point likert scale and includes 11 questions. The score zero indicates lack of a disability and 100 the most severe disability.
Strategies Used by Patients to Promote Health
时间窗: 6 months
Strategies Used by Patients to Promote Health;SUPPH is a self-report scale created by Lev and Owen to evaluate self-efficacy of individuals in development of health promotion strategies. It was adapted Turkey by Akın and its Cronbach's alpha was reported to be .92. The scale consists of 29 items. The subscale stress reduction includes the items 1-10, making decision the items 11-13, positive attitude the items 14. Each item is scored from one to five:one corresponds to very little and five very much. The lowest and the highest scores for the scale are 29 and 145 respectively. Higher scores show higher levels of self-efficacy in self-care behavior 29.
Arm Circumference Measurement Form
时间窗: 6 months
Arm Circumference Measurement Form;The form was made on four different sites on both arms:at the dorsum of the hand, the wrist, and 10cm below and above of the elbow. The difference more than 2cm between circumferences of the arms was considered as significant in terms of lymphedema.
European Organization for Research and Treatment of Cancer Quality of Life Scale for Breast Cancer 23
时间窗: 6 months
European Organization for Research and Treatment of Cancer Quality of Life Scale for Breast Cancer 23;EORTC QLQ-BR23 was adapted…by Demirci et al. The scale is composed of 23 items, a four-point scale and has two scales named FS and SS. Cronbach's alpha was reported to be .88 for the FS .66 for the SS. The FS has the subscales body image (items 39,40,41,42), sexual functions (items 44,45), sexual satisfaction (item 46), worry about the future (item 43). The SS has the subscales side effects of systematic treatment (items 31,32,33,34,36,37,38), breast symptoms (items 50,51,52,53), arm symptoms (items 47,48,49), worry about hair loss (item 35). The lowest and the highest scores for each scale are zero and 100 respectfully. Higher scores for the FS show a higher quality of life and higher scores for the SS indicate a poorer quality of life.
次要结局
未报告次要终点
研究者
Ayse Cal
Assistant Professor
Dokuz Eylul University