UMIN-ICDS Clinical Trial

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

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

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

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)

Study type

Interventional

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

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

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

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

Email

k033551@ptf.musashino-u.ac.jp

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

Email

k033551@ptf.musashino-u.ac.jp

Institute

Musashino University

Institute

Department

Personal name

Miyako Tsuchiya

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of Fucalty of Nursing, MUSASHINO UNIVERSITY

Address

3-3-3, Ariake, Koto-ku, Tokyo

Tel

0355307730

Email

kango@musashino-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

02

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2023

Year

02

Month

11

Day

Last modified on

2024

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057219