Clinical trial NCT06251856: Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery
Official title: Development and Evaluation of the Effectiveness of Lower Extremity Lymphedema Education Program After Gynecological Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Extremity Lymphedema
Keywords: lower limb lymphedema
gynecologic cancer surgery
quality of life
self-efficacy
symptom management model
patient education
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the effect of lower extremity lymphedema prevention training based on the Symptom Management Model on women undergoing gynecological cancer surgery on lymphedema development, quality of life, and women's self-efficacy. The hypotheses of the study are:

H1a: The quality of life of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is statistically significantly higher than the quality of life of women in the control group.

H1b: The self-efficacy levels of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model are statistically significantly higher than the self-efficacy levels of women in the control group.

H1c: The frequency of experiencing lower extremity lymphedema symptoms of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is significantly lower than the frequency of experiencing lower extremity lymphedema symptoms of women in the control group.

Participants will be given training on lower extremity lymphedema. At the end of the study, researchers will evaluate the impact of the training on quality of life, self-efficacy, and lymphedema development.

Detailed description: The incidence of lower extremity lymphedema following gynecological cancer treatment varies depending on the type of gynecological cancer. The prevalence of lymphedema varies between 1-38% in endometrial cancers, 17-81% in cervical cancers, 6-75% in vulvar-vaginal cancers, and 5-21% in ovarian cancers. Studies have shown that the risk of developing lymphedema after gynecological cancer persists in the long term, although the majority of cases occur in the first year. The main factors that increase the risk of developing lower extremity lymphedema are stated as Body Mass Index (BMI), age, The International Federation of Gynecology and Obstetrics (FIGO) cancer stage, lymph node dissection and number of lymph nodes. Lower extremity lymphedema is characterized by symptoms such as unilateral or bilateral swelling, heaviness, pain, itching, numbness, skin changes, infection, etc. These symptoms can seriously affect the patient's quality of life by limiting their daily living activities. Therefore, there is a need for effective interventions to prevent and manage lower extremity lymphedema associated with cancer treatment to improve quality of life and well-being. The training is planned to be structured according to the Symptom Management Model. After gynecological cancer surgery, women's ability to self-diagnose the symptoms they experience related to lymphedema and their responses to these symptoms become part of the management process. In this regard, it is thought that nurse-led education programs positioned in a theoretical framework to prevent lower extremity lymphedema will enable patients to diagnose the early symptoms of lymphedema by improving their knowledge, quality of life, self-efficacy, and reduce the risk of lymphedema. It is anticipated that the model-based nurse-led education program to be developed in this study will be applicable in the clinic and the evidence obtained will guide future research. After obtaining institutional permission, data will be collected by the researcher through a face-to-face interview with women over the age of 18 who meet the inclusion criteria. During this visit, face-to-face information about the research will be given, written consent will be obtained, and data collection tools will be introduced and filled in. The risks of the participants will be determined with the lymphedema risk assessment questionnaire and stratified randomization will be provided accordingly. Research data will be collected with the Socio-demographic Information Form, the Information Form on Cancer Diagnosis, the Lymphedema Risk Assessment Questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Scale, the 6-Item Self-Efficacy Scale for Chronic Disease Management, Gynecological Cancer Lymphedema Questionnaire and Lower extremity circumference measurement. After data collection, the data will be transferred to the Statistical Package for the Social Sciences (SPSS) 26.0 software package for analysis. The data analysis will include percentages, mean values, standard deviations and chi-square test, independent sample t-test, repeated measures ANOVA test, and the corrected Bonferroni test for advanced analyses.

Eligibility criteria: Inclusion Criteria:

* Women over 18 years of age,
* Able to speak and understand Turkish,
* Not having any cognitive, visual or auditory disabilities,
* Diagnosed with gynecological cancer (cervix, ovary, uterus, endometrium, vulva, etc.)
* Women who underwent gynecological surgery with inguinal and/or para-aortic and/or pelvic lymph node dissection due to malignancy.
* Women who have accepted and signed the consent and consent document

Exclusion Criteria:

* Women who diagnosed with venous insufficiency and peripheral artery disease,
* Women with previously diagnosed lower extremity lymphedema

Primary outcomes:
measure: Gynecological Cancer Lymphedema Questionnaire (GCLQ)- experiences of lymphedema symptoms
timeFrame: 3th month and 6th month
measure: Lower Extremity Circumference Measurement
timeFrame: baseline, 3th and 6th month
measure: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (C30-VERSION 3.0)
timeFrame: baseline, 3th and 6th month
measure: 6-Item Self-Efficacy Scale for Chronic Disease Management
timeFrame: baseline, 3th and 6th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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