Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery

NCT06251856 | Unknown DMC

• 1 other identifier: 2023.395.IRB3.172
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Extremity Lymphedema

Keywords

lower limb lymphedema; gynecologic cancer surgery; quality of life; self-efficacy; symptom management model; patient education

Outcome Measures

Primary Outcomes (4)

• Gynecological Cancer Lymphedema Questionnaire (GCLQ)- experiences of lymphedema symptoms

  The scale questions are answered with a "yes" or "no". GCLQ contains 20 questions that evaluate the presence of symptoms over the past four weeks, scored as 0. If a patient scores 20 points on GCLQ, it indicates the presence of all symptoms, while a score of 0 indicates the absence of all symptoms.

  3th month and 6th month

• Lower Extremity Circumference Measurement

  Circumference measurements will be taken in the supine position, moving from the medial malleolus to the inguinal region at 5 cm intervals for both lower extremities. The difference between both extremities will be recorded in cm. A difference of 2 cm between sides measured from at least 6 points is considered significant.

  baseline, 3th and 6th month

• The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (C30-VERSION 3.0)

  The answers are rated from "not at all" (1 point) to "a lot" (4 points). The last two questions (29th and 30th) are related to the general quality of life and ask the patient to evaluate their health and quality of life in the last week on a scale of 1 to 7 (1 being "very bad" and 7 being "very good"). High scores from these questions indicate high quality of life, while low scores indicate low quality of life.; very bad, 7 points; very good).

  baseline, 3th and 6th month

• 6-Item Self-Efficacy Scale for Chronic Disease Management

  The scale consists of six items, with the first four measuring behavioral attitude and the last two measuring psychological attitude. Each item is rated on a 10-point scale ranging from "not at all confident" to "completely confident." To obtain the score, the average of all six items is calculated, with higher scores indicating greater self-efficacy.

  baseline, 3th and 6th month

Study Arms (2)

lymphedema education

EXPERIMENTAL

Participants will receive lymphedema education and educational brochures from the researcher on the 2nd day after gynecological cancer surgery.

Behavioral: lymphedema education program

routine discharge education

NO INTERVENTION

Routine post-op discharge education is given to patients who undergo gynecological cancer surgery at the institution by nurses on the day of discharge.

Interventions

lymphedema education program BEHAVIORAL

On post-op day 2, patients will receive Symptom Management Model-Based Lower Extremity Lymphedema Training. Brochures will be introduced and delivered to the patient.

lymphedema education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Related Publications (11)

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 BACKGROUND

• Abakay H, Abdulrezzak U, Akbayrak T. (2022). An Important Tool in Lymphedema Management: Validation of the Turkish Version of the Gynecologic Cancer Lymphedema Questionnaire. Gynecol Obstet Reprod Med. https://doi.org/10.21613/GORM.2022.1348

  BACKGROUND

• Backler C, Beck M, Poage E. Lymphedema: Clinical Summary of the ONS Guidelines for Cancer Treatment-Related Lymphedema. Clin J Oncol Nurs. 2020 Oct 1;24(5):566-570. doi: 10.1188/20.CJON.566-570.

  PMID: 32945785 BACKGROUND

• Bakar Y, Tugral A. Lower Extremity Lymphedema Management after Gynecologic Cancer Surgery: A Review of Current Management Strategies. Ann Vasc Surg. 2017 Oct;44:442-450. doi: 10.1016/j.avsg.2017.03.197. Epub 2017 May 5.

  PMID: 28483624 BACKGROUND

• Hayes SC, Janda M, Ward LC, Reul-Hirche H, Steele ML, Carter J, Quinn M, Cornish B, Obermair A. Lymphedema following gynecological cancer: Results from a prospective, longitudinal cohort study on prevalence, incidence and risk factors. Gynecol Oncol. 2017 Sep;146(3):623-629. doi: 10.1016/j.ygyno.2017.06.004. Epub 2017 Jun 16.

  PMID: 28624154 BACKGROUND

• Bowman C, Piedalue KA, Baydoun M, Carlson LE. The Quality of Life and Psychosocial Implications of Cancer-Related Lower-Extremity Lymphedema: A Systematic Review of the Literature. J Clin Med. 2020 Oct 2;9(10):3200. doi: 10.3390/jcm9103200.

  PMID: 33023211 BACKGROUND

• Cal A, Bahar Z, Gorken I. Effects of Health Belief Model based nursing interventions offered at home visits on lymphedema prevention in women with breast cancer: A randomised controlled trial. J Clin Nurs. 2020 Jul;29(13-14):2521-2534. doi: 10.1111/jocn.15271. Epub 2020 Apr 17.

  PMID: 32243029 BACKGROUND

• Cankurtaran ES, Ozalp E, Soygur H, Ozer S, Akbiyik DI, Bottomley A. Understanding the reliability and validity of the EORTC QLQ-C30 in Turkish cancer patients. Eur J Cancer Care (Engl). 2008 Jan;17(1):98-104. doi: 10.1111/j.1365-2354.2007.00827.x.

  PMID: 18181898 BACKGROUND

• Deura I, Shimada M, Hirashita K, Sugimura M, Sato S, Sato S, Oishi T, Itamochi H, Harada T, Kigawa J. Incidence and risk factors for lower limb lymphedema after gynecologic cancer surgery with initiation of periodic complex decongestive physiotherapy. Int J Clin Oncol. 2015 Jun;20(3):556-60. doi: 10.1007/s10147-014-0724-0. Epub 2014 Jul 4.

  PMID: 24993674 BACKGROUND

• Do JH, Choi KH, Ahn JS, Jeon JY. Effects of a complex rehabilitation program on edema status, physical function, and quality of life in lower-limb lymphedema after gynecological cancer surgery. Gynecol Oncol. 2017 Nov;147(2):450-455. doi: 10.1016/j.ygyno.2017.09.003. Epub 2017 Sep 20.

  PMID: 28941657 BACKGROUND

• Incirkus K, Nahcivan N. Validity and reliability study of the Turkish version of the self-efficacy for managing chronic disease 6-item scale. Turk J Med Sci. 2020 Aug 26;50(5):1254-1261. doi: 10.3906/sag-1910-13.

  PMID: 32336077 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-01