Evaluation of Lymphedema Patients Status During Covid-19 Pandemic
1 other identifier
observational
60
1 country
1
Brief Summary
The pandemic, which started in China at the end of 2019, appeared in our country in a short time. Most hospitals and physicians were only concerned with the treatment of these patients. One of the most victimized patient groups in this duration was lymphedema patients who were in need of continuous follow-up and rehabilitation at necessary periods, but were also at risk in terms of covid-19 infection and could not go to hospitals unless necessary. The treatment of both primary and secondary lymphedema patients has been interrupted or delayed. This process has affected the health status, treatment processes and quality of life of the lymphedema patient group. The current situation may have caused them anxiety and depression as a result of infection fear. In this study, we aimed to evaluate the treatment processes, health status, coronavirus phobia, anxiety, and depression states of the lymphedema patients .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedOctober 8, 2020
October 1, 2020
2 months
September 25, 2020
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Coronavirus Phobia Scale
The CP19-S has 20 items which is a self-report instrument with a five-point Likert-type scale to assess the levels of coronavirus (covid-19) phobia. All items are rated on a 5 point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales (psychological, psycho-somatic, economic and social) and total scale. In the present study total scale scores ranged from 20 to 100 .
1 day
Lymphedema Quality of Life Arm
The LYMQOL-Arm consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QOL. Domain totals were calculated by adding the individual scores and dividing the total by the number of questions answered (If \>50% of questions per domain were not answered this cannot be calculated \*and =0). If the item was not scored and left blank or not applicable, this was scored with a 0. The four domains and their corresponding questions are: Function 1 (a-h), 2,3, Appearance 4,5,6,7,8 Symptoms 9,10,11,12,13,14 and Emotion 15,16,17,18,19,20. Overall QOL (Q21) is scored as the value marked by the patient, between 0-10
1 day
Lymphedema Quality of Life Leg
The LYMQOL-Leg consists of 27 items: 26 multiple-choice questions and 1 rating question. It covers four domains: symptoms, appearance, function, and mood. Scoring and calculating is same with the arm scale but differences are; function 1 (a-f), 2,3 appearance 4,5,6,7,8,9,10 symptoms 11,12,13,14,15 and emotion 16,17,18,19,20,21. Overall quality of life (Q22) is scored as the value marked by the patient, between 0-10.
1 day
Hospital Anxiety and Depression Scale
It consists of 14 items with two subscales (seven items for anxiety and seven items for depression). Each item is scored 0-3. Each subscale is scored between 0 and 21. The aim of the scale is not to make a diagnosis, but to determine the risk group bt screening anxiety and depression in a short time in patients with physical diseases. The cut-off points of the Turkish version of the HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
1 day
Eligibility Criteria
Primary or secondary lymphedema patients who aged over 18.
You may qualify if:
- Primary or secondary lymphedema patients with stage I,II,II stage
- Aged over 18 years old
- Upper or lower extremity lymphedema
You may not qualify if:
- Patients under the age of 18
- Patients who do not accept phone calls.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Ataşehir, 34752, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feyza Akan Begoğlu, MD
Fatih Sultan Mehmet Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
September 29, 2020
Study Start
June 1, 2020
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share