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Fertility Preservation in Male AYA With Cancer

Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04268004
Enrollment
53
Registered
2020-02-13
Start date
2021-02-08
Completion date
2025-06-01
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

Keywords

Cancer, Fertility Preservation, Parenthood

Brief summary

Very little is known about how medical providers can help adolescent and young adults (AYAs) and their caregivers make decisions about fertility preservation (sperm banking) before beginning cancer treatment. The purpose of this study is to see if having a guided conversation about fertility preservation increases preservation rates and/or satisfaction with the decision among AYA males with cancer. The primary hypothesis is that compared to standard of care control group (routine fertility consult at diagnosis, n=20), AYAs in the intervention arm (routine fertility consult at diagnosis + FP Decision Tool and Facilitated Conversation by trained interventionist) will have higher rates of FP uptake. The secondary hypothesis is that families in the intervention group will report better FP decision quality compared to those in the control arm.

Detailed description

A rapidly growing population of male childhood cancer survivors are at risk for infertility and distress. As the number of male cancer survivors rises, it is essential to minimize treatment late effects. One of the most prevalent and significant complications among males is infertility, which can impair psychosocial development and reduce quality of life. National guidelines emphasize offering fertility preservation (FP) prior to initiation of cancer therapy, and sperm cryopreservation is an established and generally noninvasive FP method for pubertal males. Early research suggested only males receiving high doses of alkylating agents should bank sperm. However, variable sperm counts following equivalent doses of cyclophosphamide and scenarios in which patients have to move quickly from low risk treatments (which transiently impair sperm production) to high risk treatments, support the premise that all males receiving chemotherapy and/or gonadal radiation should consider FP at diagnosis. Despite studies showing \ 50% of male childhood cancer survivors have fertility impairment, reports from many centers show only \ 25% of pubertal males bank sperm prior to treatment. As survivors enter their reproductive years, many regret missed opportunities for FP and experience distress about potential infertility. Thus, interventions to improve FP uptake would have great potential for reproductive and psychological benefit. Individual and family factors associated with sperm banking decisions remain poorly understood. Young age, cost, inadequate knowledge, and urgency to start treatment are common barriers to FP among AYA males with newly diagnosed cancer. As a result, most fertility counseling and FP interventions have targeted healthcare providers and systems or provider-patient interactions. While these are critical factors, less than half of male AYA advised about FP in a recent study actually banked sperm, indicating knowledge is not sufficient. The purpose of this study is to test a decision tool and accompanying guided discussion as a method of improving decision making regarding FP, compared to a standard of care fertility consult.

Interventions

BEHAVIORALFP Decision Tool and Discussion

The intervention will be administered by a trained interventionist. The interventionist will administer the digital FP Decision Tool to families in the intervention arm. The tool asks questions examining each AYA's thoughts or feelings regarding parenthood and fertility preservation. The parent version asks the same questions, plus additional questions asking the parent to rate their son's feelings on certain topics (i.e., whether their son wants to have a child, whether their son would be as happy with an adopted child versus a biological child). Items are coded based on the domains of the Health Belief Model (perceived benefits, perceived barriers, perceived threats, self-efficacy, and cues to action). Items are scored and the trained interventionist will facilitate a guided discussion based on the family's responses and discrepancies.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Leena Nahata
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Participants, the interventionist, and research staff will not be blinded.

Intervention model description

Families will be randomly assigned to receive standard care or to receive standard care plus the investigator's study intervention. All families will then be followed for a year to assess outcomes.

Eligibility

Sex/Gender
MALE
Age
12 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Male * Aged 12-25 years * Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed cancer * Pubertal (at least Tanner stage 2-3, eligible for sperm banking as determined in the fertility consult) * Proficient in English

Exclusion criteria

* Cognitive deficit that precludes completing measures * Parents are non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Fertility Preservation (FP) UptakeBaseline to before AYA begins treatment (generally within one to two weeks from baseline)Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)

Secondary

MeasureTime frameDescription
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA1-month post randomizationAYAs 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.
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver1-month post randomizationCaregivers 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

No participants were excluded from the study after enrollment, but before assignment to groups.

Participants by arm

ArmCount
Standard of Care (Control)
Participants will receive a standard of care fertility consult.
25
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.
26
Total51

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyExcluded from analyses01

Baseline characteristics

CharacteristicStandard of Care (Control)FP Decision Tool and Discussion (Treatment)Total
Age, Continuous
Adolescents
17 Mean17 Mean17 Mean
Age, Continuous
Caregivers
46 Mean44 Mean45 Mean
Age, Continuous
Overall
33 Mean31 Mean32 Mean
Ethnicity (NIH/OMB)
Adolescents
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Adolescents
Not Hispanic or Latino
9 Participants9 Participants18 Participants
Ethnicity (NIH/OMB)
Adolescents
Unknown or Not Reported
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Caregiver
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Caregiver
Not Hispanic or Latino
14 Participants16 Participants30 Participants
Ethnicity (NIH/OMB)
Caregiver
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Overall
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Overall
Not Hispanic or Latino
23 Participants25 Participants48 Participants
Ethnicity (NIH/OMB)
Overall
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Adolescents
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescents
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Adolescents
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescents
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescents
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescents
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Adolescents
White
9 Participants8 Participants17 Participants
Race (NIH/OMB)
Caregivers
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Caregivers
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Caregivers
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Caregivers
More than one race
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Caregivers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Caregivers
White
12 Participants11 Participants23 Participants
Race (NIH/OMB)
Overall
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Overall
Asian
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Overall
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Overall
More than one race
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Overall
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Overall
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Overall
White
21 Participants19 Participants40 Participants
Sex: Female, Male
Adolescents
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Adolescents
Male
10 Participants9 Participants19 Participants
Sex: Female, Male
Caregivers
Female
12 Participants9 Participants21 Participants
Sex: Female, Male
Caregivers
Male
3 Participants8 Participants11 Participants
Sex: Female, Male
Overall
Female
12 Participants9 Participants21 Participants
Sex: Female, Male
Overall
Male
13 Participants17 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 90 / 150 / 17
other
Total, other adverse events
0 / 100 / 90 / 150 / 17
serious
Total, serious adverse events
0 / 100 / 90 / 150 / 17

Outcome results

Primary

Fertility Preservation (FP) Uptake

Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of Care (Control)Fertility Preservation (FP) Uptake10 Participants
FP Decision Tool and Discussion (Treatment)Fertility Preservation (FP) Uptake9 Participants
Comparison: Chi-square test was used to determine if study arm is associated with FP uptake.p-value: =0.64Chi-squared
Secondary

Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA

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.

Time frame: 1-month post randomization

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Regret Mean1.9 MeanStandard Deviation 1.6
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Satsifaction Mean5.9 MeanStandard Deviation 1.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Information Mean6.3 MeanStandard Deviation 1
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Time Mean4.6 MeanStandard Deviation 2.6
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Involvement Mean6.1 MeanStandard Deviation 1.5
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Right for You Mean3.9 MeanStandard Deviation 2.5
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Involvement Mean6.8 MeanStandard Deviation 0.7
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Regret Mean1.0 MeanStandard Deviation 0
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Time Mean6.3 MeanStandard Deviation 1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Satsifaction Mean5.3 MeanStandard Deviation 2.5
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Right for You Mean5.4 MeanStandard Deviation 1.4
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Information Mean6.3 MeanStandard Deviation 1
Secondary

Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA

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.

Time frame: 1-year post randomization

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Regret1.7 MeanStandard Deviation 1
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BDSQ Satisfaction5.7 MeanStandard Deviation 1.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Information6.1 MeanStandard Deviation 2
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Time5.7 MeanStandard Deviation 2
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Involvement6.5 MeanStandard Deviation 1.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Right for you4.6 MeanStandard Deviation 1.7
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Involvement5.9 MeanStandard Deviation 2
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Regret1.1 MeanStandard Deviation 0.3
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Time6.3 MeanStandard Deviation 1.4
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BDSQ Satisfaction6.0 MeanStandard Deviation 1.5
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Right for you5.7 MeanStandard Deviation 1.7
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - AYAAdolescent BSDQ Information6.3 MeanStandard Deviation 2
Secondary

Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver

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.

Time frame: 1-month post randomization

Population: Some participants skipped individual items. Some participants did not complete this 1-month post randomization visit.

ArmMeasureGroupValue (MEAN)Dispersion
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Regret2.6 MeanStandard Deviation 2.2
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Satisfaction5.6 MeanStandard Deviation 2
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Information5.7 MeanStandard Deviation 2.1
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Time4.5 MeanStandard Deviation 2.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Involvement5.5 MeanStandard Deviation 2.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Right for you5.5 MeanStandard Deviation 2.1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Involvement5.7 MeanStandard Deviation 2
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Regret1.4 MeanStandard Deviation 1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Time5.1 MeanStandard Deviation 1.5
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Satisfaction5.7 MeanStandard Deviation 2.2
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Right for you5.0 MeanStandard Deviation 1.9
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Information5.7 MeanStandard Deviation 2
Secondary

Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver

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.

Time frame: 1-year post randomization

Population: Some participants skipped individual items. Some participants did not complete this 1-year post randomization visit.

ArmMeasureGroupValue (MEAN)Dispersion
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Regret1.8 MeanStandard Deviation 1.4
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Satisfaction5.4 MeanStandard Deviation 1.8
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Information6.5 MeanStandard Deviation 0.9
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Time3.8 MeanStandard Deviation 2.6
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Involvement6.8 MeanStandard Deviation 0.7
Standard of Care (Control)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Right for you4.3 MeanStandard Deviation 1.6
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Involvement5.9 MeanStandard Deviation 1.8
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Regret1.4 MeanStandard Deviation 1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Time4.8 MeanStandard Deviation 1.9
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Satisfaction5.9 MeanStandard Deviation 2.1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Right for you5.1 MeanStandard Deviation 2.1
FP Decision Tool and Discussion (Treatment)Brief Subjective Decision Quality (BSDQ) Questionnaire - CaregiverCaregiver BSDQ Information7.0 MeanStandard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026