UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056476 |
|---|---|
| Receipt number | R000064537 |
| Scientific Title | Examining the effectiveness of awareness education programs for cancer prevention and early detection for adolescent girls and their mothers |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2025/06/18 22:35:27 |
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Basic information
Public title
Examining the effectiveness of awareness education programs for cancer prevention and early detection for adolescent girls and their mothers
Acronym
Examining the effectiveness of cancer awareness education programs for adolescents and their mothers
Scientific Title
Examining the effectiveness of awareness education programs for cancer prevention and early detection for adolescent girls and their mothers
Scientific Title:Acronym
Examining the effectiveness of cancer awareness education programs for adolescents and their mothers
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to conduct an awareness education program for prevention and early detection of cancer among adolescent girls and their mothers, and to examine the effectiveness and validity of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cancer awareness, cancer prevention behaviors, breast self-check implementation rate, cancer screening change stage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Intervention through awareness education programs for cancer prevention and early detection
The intervention consists of three parts: providing information on cancer prevention and early detection, discussing cancer prevention with parents and children, and practicing breast self-examination.
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
| 13 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
(i) Adolescent girls in junior high and high school and their mothers
(ii) Parents and their children are able to participate in the program
(iii) Neither the female student nor her mother has received cancer treatment in the past
(iv) Those who can obtain written consent for participation in the study from the subjects themselves and their mothers.
Key exclusion criteria
(i) Those who cannot read or write Japanese.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumi |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL
0726847281
kumi.suzuki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kumi |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL
0726847281
Homepage URL
kumi.suzuki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
7-6, Hatchonishi-machi, Takatsuki, Osaka
Tel
0726847281
kumi.suzuki@ompu.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
| 2024 | Year | 12 | Month | 17 | 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
40
Results
The results demonstrated a significant increase in participants'awareness of cancer warning signs(p=0.001, p=0.019) and risk factors(p=0.002, p<0.001), as well as a reduction in perceived barriers to seeking medical help(p=0.022, p=0.023) before and after the intervention. Additionally, the program strengthened the girls' intentions to adopt preventive behaviors and led to behavioral changes in breast self-examination among their mothers.
Results date posted
| 2025 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 20 pairs of middle and high school students and their mothers. The average age of the middle and high school students was 15.1 years (SD=1.5); 13 (65%) were middle school students and 7 (35%) were high school students. Six (30%) were public and 13 (70%) were private school establishment. Those who had a cancer experience of someone close to them were 10 family members, 6 relatives, and no friends or acquaintances. Furthermore, 13 (65%) had received cancer education at school. On the other hand, the average age of the mothers was 48.5 years (SD=3.9), and 17 (85%) had an occupation. Those who had a close person's cancer experience included 2 spouses, 14 family members, 11 relatives, and 10 friends/acquaintances. Two had attended lectures on cancer in the past, and three were aware of cancer education at their children's schools.
Participant flow
Adverse events
Non
Outcome measures
Cancer Awareness and Cancer Prevention Behavioral Intentions of Middle and High School Girls
Cancer awareness and cancer screening behavior of their mothers
Frequency of parent-child conversations about cancer
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064537
