Health Belief Model Based Nursing Interventions on Lymphedema Prevention

NCT04098783 | Completed DMC

• 1 other identifier: 04.04.2013 970-GOA
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

• 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.

Conditions

Breast Cancer; Breast Cancer Lymphedema; Home Visit

Keywords

Breast Cancer; Lymphedema; Health Belief Model; Nursing; Home Visit

Outcome Measures

Primary Outcomes (4)

• 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

• 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 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.

  6 months

• 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

• 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

Study Arms (2)

Nursing interventions (home visit and health education) group

EXPERIMENTAL

Nursing interventions group: Home visit, health education At the Intervention group; the researcher made pretest (baseline measurements) before the nursing interventions at the first home visit. The researcher offered education and guide about prevention of lymphedema after the baseline measurements at the first home visit. Second and third home visits were made three and six months after the first visit. At the second and the third home visits, the measurements were repeated, and the nursing interventions were maintained in the direction of the patients' individual needs.

Other: Home visit, health education

No Nursing interventions group

NO INTERVENTION

No Nursing interventions group; the researcher administered the pretests at first home visit. The measurements were repeated in the third and sixth months after the first home visit. The researcher also given at the end of the sixth month, all of the nursing interventions, given to the intervention group, for the control group.

Interventions

Home visit, health education OTHER

Nursing interventions (home visit and health education) group

Eligibility Criteria

• Age: 28 Years - 77 Years
• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayse Cal: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema; Lymphedema

Interventions

House Calls

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Ayse Cal, Asst Prof

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

• Zuhal Bahar, Prof

  Koç University

  STUDY DIRECTOR

• Ilknur Gorken, Prof

  Dokuz Eylul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 23, 2019
• Study Start: May 15, 2016
• Primary Completion: April 15, 2017
• Study Completion: July 13, 2017
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share