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Health Belief Model Based Nursing Interventions on Lymphedema Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098783
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Ayse Cal, Dokuz Eylul University

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

  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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Lymphedema Home Visit Other: Home visit, health education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled experimental design
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : May 15, 2016
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : July 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nursing interventions (home visit and health education) group
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 Intervention: No Nursing interventions group
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.



Primary Outcome Measures :
  1. Quick-Disabilities of the Arm, Shoulder and Hand Score [ Time Frame: 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.

  2. Strategies Used by Patients to Promote Health [ Time Frame: 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.

  3. European Organization for Research and Treatment of Cancer Quality of Life Scale for Breast Cancer 23 [ Time Frame: 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.

  4. Arm Circumference Measurement Form [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with breast cancer
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098783


Sponsors and Collaborators
Ayse Cal
The Scientific and Technological Research Council of Turkey
Investigators
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Principal Investigator: Ayse Cal, Asst Prof Ankara Medipol University
Study Director: Zuhal Bahar, Prof Koç University
Study Chair: Ilknur Gorken, Prof Dokuz Eylul University
  Study Documents (Full-Text)

Documents provided by Ayse Cal, Dokuz Eylul University:
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Responsible Party: Ayse Cal, Assistant Professor, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04098783    
Other Study ID Numbers: 04.04.2013 970-GOA
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayse Cal, Dokuz Eylul University:
Breast Cancer
Lymphedema
Health Belief Model
Nursing
Home Visit
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes