UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050309 |
|---|---|
| Receipt number | R000057219 |
| Scientific Title | Efficacy evaluation of online lymphoedema prevention support program after breast and gynaecologic cancer surgery: a single-arm trial |
| Date of disclosure of the study information | 2023/02/12 |
| Last modified on | 2025/02/20 11:19:13 |
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Basic information
Public title
Efficacy evaluation of online lymphoedema prevention support program
Acronym
Efficacy evaluation of online lymphoedema prevention support program
Scientific Title
Efficacy evaluation of online lymphoedema prevention support program after breast and gynaecologic cancer surgery: a single-arm trial
Scientific Title:Acronym
Efficacy evaluation of online lymphoedema prevention support program after breast and gynaecologic cancer surgery
Region
| Japan |
Condition
Condition
Breast cancer, gynaecologic cancer (cervical cancer, endometrial cancer, ovarian cancer/fallopian tube cancer/peritoneal cancer)
Classification by specialty
| Breast surgery | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether our four-session online lymphoedema prevention support program could improve self-efficacy in self-care for lymphoedema prevention, anxiety/stress, knowledge, BMI, and QOL among breast and gynaecologic cancer patients who underwent surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assessment time points of the primary outcome are before program attendance (T0), after completion of the 3rd session (T1:3 months after T0), and after completion of the 4th session (T2: 9 months after T0).
The primary outcome is self-efficacy in self-care of lymphoedema prevention.
Key secondary outcomes
1. Knowledge of self-care for lymphoedema prevention (T0, T1, T2)
2. Anxiety and stress with lymphoedema and self-care (T0, T1, T2)
3. BMI (every month between the 1st and the 4th sessions)
4. QOL (T0, T1, T2)
5. Fatigue (T0)
6. Degree of understanding, enjoyment, and satisfaction with each session (after the 1st, 2nd, 3rd, and 4th sessions)
7. Self-monitoring of self-care (monthly between the 1st and 4th sessions)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We provide a four-session online lymphoedema prevention support program (60 minutes per session). The 1st to 3rd sessions are held every month, and the 4th session is held 6 months after the 3rd session. We deliver lectures and facilitate groupwork relating to self-care for lymphoedema prevention, review of lifestyle habits, and coping strategies with stress, including breathing practice between the 1st and the 3rd sessions. In groupwork, we encourage participants to share their experiences, set up self-care goals, and modify them whenever necessary. Participants try their own self-care plan and record it as homework (eight times). The 4th session is the follow-up. We encourage participants to review their experiences of the program and to clear their doubts and anxiety.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients who underwent surgery for breast cancer, gynaecologic cancer (cervical cancer, endometrial cancer, or ovarian cancer/fallopian tube cancer/peritoneal cancer) (regardless of multiple cancers, stage, or years since surgery);
2. Women, 18 years old or older at the time of consent;
3. Those who are physically and mentally able to participate in this research;
4. Those who have proficiency in Japanese;
5. Those who have personal computers or mobile devices such as tablets and mobile phones;
6. Those who have access to the internet;
7. Those who can access online meeting platforms;
8. Those who plan to participate in all four-sessions of the online lymphoedema prevention support program;
9. Those who can give either electronic or written consent.
Key exclusion criteria
1. Patients who are undergoing treatment or follow-up, and judged by their doctors to be unsuitable for this study at the time of either electronic or written consent;
2. Those who are already diagnosed with lymphoedema at the time of registration for this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Miyako |
| Middle name | |
| Last name | Tsuchiya |
Organization
Musashino University
Division name
Research Institute of Nursing
Zip code
135-8181
Address
3-3-3, Ariake, Koto-ku, Tokyo
TEL
0355307730
k033551@ptf.musashino-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyako |
| Middle name | |
| Last name | Tsuchiya |
Organization
Musashino University
Division name
Research Institute of Nursing
Zip code
135-8181
Address
3-3-3, Ariake, Koto-ku, Tokyo
TEL
0355307730
Homepage URL
k033551@ptf.musashino-u.ac.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
Miyako Tsuchiya
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Fucalty of Nursing, MUSASHINO UNIVERSITY
Address
3-3-3, Ariake, Koto-ku, Tokyo
Tel
0355307730
kango@musashino-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interim analysis has performed in Feburary 2024.
Additional recruit has begun in June 2024 and November 2025.
Management information
Registered date
| 2023 | Year | 02 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057219
