Breast Cancer Clinical Trial
Official title:
Effects of Health Belief Model Based Nursing Interventions Offered at Home Visits on Lymphedema Prevention in Women With Breast Cancer: A Randomized Controlled Trial
Verified date | September 2019 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
1. Extremity function restrictions will be lower in the intervention group than in the
control group.
2. Self-efficacy levels will be higher in the intervention group than in the control group.
3. Functions improving the quality of life will be higher in the intervention group than in
the control group.
4. There will be fewer symptoms reducing the quality of life in the intervention group than
in the control group.
5. The incidence of lymphedema will be lower in the intervention group than in the control
group.
6. 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.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 13, 2017 |
Est. primary completion date | April 15, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Female - Residing in the city Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ayse Cal | The Scientific and Technological Research Council of Turkey |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick-Disabilities of the Arm, Shoulder and Hand Score | 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. | 6 months | |
Primary | Strategies Used by Patients to Promote Health | 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 Akin 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. | 6 months | |
Primary | European Organization for Research and Treatment of Cancer Quality of Life Scale for Breast Cancer 23 | 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. | 6 months | |
Primary | Arm Circumference Measurement Form | 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. | 6 months |
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