Trial Outcomes & Findings for Reproductive Health Survivorship Care Plan Pilot (NCT NCT02176083)
NCT ID: NCT02176083
Last Updated: 2020-04-20
Results Overview
Median number of daily hot flashes over 4th week of study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
1 week
Results posted on
2020-04-20
Participant Flow
Participant milestones
| Measure |
Intervention
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Text message management prompts
|
Control
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
27
|
|
Overall Study
COMPLETED
|
11
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reproductive Health Survivorship Care Plan Pilot
Baseline characteristics by cohort
| Measure |
Intervention
n=11 Participants
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Text message management prompts
|
Control
n=27 Participants
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
27 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekMedian number of daily hot flashes over 4th week of study
Outcome measures
| Measure |
Intervention
n=11 Participants
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Text message management prompts
|
Control
n=27 Participants
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
|
|---|---|---|
|
Hot Flash Frequency
|
2.2 daily hot flashes
Interval 1.2 to 3.6
|
1.4 daily hot flashes
Interval 0.7 to 2.3
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place