Trial Outcomes & Findings for Fertility Preservation in Male AYA With Cancer (NCT NCT04268004)
NCT ID: NCT04268004
Last Updated: 2025-07-29
Results Overview
Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Baseline to before AYA begins treatment (generally within one to two weeks from baseline)
Results posted on
2025-07-29
Participant Flow
Patients were recruited based on a medical chart review identifying patients with a new cancer diagnosis and/or through an automatic referral placed to the multidisciplinary Fertility and Reproductive Health Team following a new cancer diagnosis. Recruitment occurred at a single site (Nationwide Children's Hospital) in inpatient, outpatient, and remote settings. Recruitment occurred between February of 2021 and January of 2024.
No participants were excluded from the study after enrollment, but before assignment to groups.
Participant milestones
| Measure |
Standard of Care (Control)
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
Adolescents Started
|
10
|
9
|
|
Overall Study
Caregivers Started
|
15
|
18
|
|
Overall Study
Adolescents Completed
|
10
|
9
|
|
Overall Study
Caregivers Completed
|
15
|
17
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care (Control)
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Overall Study
Excluded from analyses
|
0
|
1
|
Baseline Characteristics
Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
Baseline characteristics by cohort
| Measure |
Standard of Care (Control)
n=25 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=26 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Adolescents
|
17 Mean
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
17 Mean
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
17 Mean
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Age, Continuous
Caregivers
|
46 Mean
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
44 Mean
n=13 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
45 Mean
n=28 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Age, Continuous
Overall
|
33 Mean
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
31 Mean
n=22 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
32 Mean
n=47 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Adolescents · Female
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Adolescents · Male
|
10 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
9 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
19 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Caregivers · Female
|
12 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
9 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
21 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Caregivers · Male
|
3 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
8 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
11 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Overall · Female
|
12 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
9 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
21 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Sex: Female, Male
Overall · Male
|
13 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
17 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
30 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined. As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
|
|
Ethnicity (NIH/OMB)
Adolescents · Hispanic or Latino
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Adolescents · Not Hispanic or Latino
|
9 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
9 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
18 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Adolescents · Unknown or Not Reported
|
1 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
|
1 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
|
14 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
16 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
30 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
|
0 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Overall · Hispanic or Latino
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Overall · Not Hispanic or Latino
|
23 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
25 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
48 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Ethnicity (NIH/OMB)
Overall · Unknown or Not Reported
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · American Indian or Alaska Native
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · Asian
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · Black or African American
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · White
|
9 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
8 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
17 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · More than one race
|
0 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Adolescents · Unknown or Not Reported
|
1 Participants
n=10 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=9 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=19 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
1 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
1 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · White
|
12 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
11 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
23 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
1 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
3 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
4 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=15 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=17 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=32 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · American Indian or Alaska Native
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · Asian
|
0 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
3 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
3 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · Black or African American
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
2 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · White
|
21 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
19 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
40 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · More than one race
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
3 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
4 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
|
Race (NIH/OMB)
Overall · Unknown or Not Reported
|
1 Participants
n=25 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
0 Participants
n=26 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
1 Participants
n=51 Participants • Rows refer to the number of specific participant types (adolescents and caregivers separately) whereas the Overall number refers to the number of participants combined.
|
PRIMARY outcome
Timeframe: Baseline to before AYA begins treatment (generally within one to two weeks from baseline)Population: As a note, discrepancies between baseline characteristics and participant flow are attributed to missing data/skipped questions.
Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)
Outcome measures
| Measure |
Standard of Care (Control)
n=10 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=9 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Fertility Preservation (FP) Uptake
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1-month post randomizationPopulation: These analyses were conducted on each BSDQ item by participant type (adolescents and caregivers). Some participants skipped questions resulting in differences in "n" values by each item. Some participants did not complete this 1-month post randomization visit.
AYAs will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.
Outcome measures
| Measure |
Standard of Care (Control)
n=9 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=9 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Regret Mean
|
1.9 Mean
Standard Deviation 1.6
|
1.0 Mean
Standard Deviation 0.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Satsifaction Mean
|
5.9 Mean
Standard Deviation 1.4
|
5.3 Mean
Standard Deviation 2.5
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Information Mean
|
6.3 Mean
Standard Deviation 1.0
|
6.3 Mean
Standard Deviation 1.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Time Mean
|
4.6 Mean
Standard Deviation 2.6
|
6.3 Mean
Standard Deviation 1.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Involvement Mean
|
6.1 Mean
Standard Deviation 1.5
|
6.8 Mean
Standard Deviation 0.7
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ "Right for You" Mean
|
3.9 Mean
Standard Deviation 2.5
|
5.4 Mean
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 1-month post randomizationPopulation: Some participants skipped individual items. Some participants did not complete this 1-month post randomization visit.
Caregivers will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.
Outcome measures
| Measure |
Standard of Care (Control)
n=11 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=14 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Regret
|
2.6 Mean
Standard Deviation 2.2
|
1.4 Mean
Standard Deviation 1.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Satisfaction
|
5.6 Mean
Standard Deviation 2.0
|
5.7 Mean
Standard Deviation 2.2
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Information
|
5.7 Mean
Standard Deviation 2.1
|
5.7 Mean
Standard Deviation 2.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Time
|
4.5 Mean
Standard Deviation 2.4
|
5.1 Mean
Standard Deviation 1.5
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Involvement
|
5.5 Mean
Standard Deviation 2.4
|
5.7 Mean
Standard Deviation 2.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ "Right for you"
|
5.5 Mean
Standard Deviation 2.1
|
5.0 Mean
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 1-year post randomizationPopulation: These analyses were conducted on each BSDQ item by participant type (adolescents and caregivers). Some participants skipped questions resulting in differences in "n" values by each item. Some participants did not complete this 1-year post randomization visit.
AYAs will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.
Outcome measures
| Measure |
Standard of Care (Control)
n=9 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=9 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Regret
|
1.7 Mean
Standard Deviation 1.0
|
1.1 Mean
Standard Deviation 0.3
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BDSQ Satisfaction
|
5.7 Mean
Standard Deviation 1.4
|
6.0 Mean
Standard Deviation 1.5
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Information
|
6.1 Mean
Standard Deviation 2.0
|
6.3 Mean
Standard Deviation 2.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Time
|
5.7 Mean
Standard Deviation 2.0
|
6.3 Mean
Standard Deviation 1.4
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ Involvement
|
6.5 Mean
Standard Deviation 1.4
|
5.9 Mean
Standard Deviation 2.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Adolescent BSDQ "Right for you"
|
4.6 Mean
Standard Deviation 1.7
|
5.7 Mean
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 1-year post randomizationPopulation: Some participants skipped individual items. Some participants did not complete this 1-year post randomization visit.
Caregivers will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.
Outcome measures
| Measure |
Standard of Care (Control)
n=8 Participants
Participants will receive a standard of care fertility consult.
|
FP Decision Tool and Discussion (Treatment)
n=9 Participants
Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.
|
|---|---|---|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Regret
|
1.8 Mean
Standard Deviation 1.4
|
1.4 Mean
Standard Deviation 1.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Satisfaction
|
5.4 Mean
Standard Deviation 1.8
|
5.9 Mean
Standard Deviation 2.1
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Information
|
6.5 Mean
Standard Deviation 0.9
|
7.0 Mean
Standard Deviation 0.0
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Time
|
3.8 Mean
Standard Deviation 2.6
|
4.8 Mean
Standard Deviation 1.9
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ Involvement
|
6.8 Mean
Standard Deviation 0.7
|
5.9 Mean
Standard Deviation 1.8
|
|
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Caregiver BSDQ "Right for you"
|
4.3 Mean
Standard Deviation 1.6
|
5.1 Mean
Standard Deviation 2.1
|
Adverse Events
Standard of Care (Control) - Adolescent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP Decision Tool and Discussion (Treatment) - Adolescent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care (Control) - Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FP Decision Tool and Discussion (Treatment) -Caregivers
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