Infertility, Male
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Fertility Preservation (FP) Uptake | Baseline 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | 1-month post randomization | 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. |
| Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | 1-month post randomization | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from analyses | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care (Control) | FP Decision Tool and Discussion (Treatment) | Total |
|---|---|---|---|
| Age, Continuous Adolescents | 17 Mean | 17 Mean | 17 Mean |
| Age, Continuous Caregivers | 46 Mean | 44 Mean | 45 Mean |
| Age, Continuous Overall | 33 Mean | 31 Mean | 32 Mean |
| Ethnicity (NIH/OMB) Adolescents Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Adolescents Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Adolescents Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Caregiver Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Caregiver Not Hispanic or Latino | 14 Participants | 16 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Overall Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Overall Not Hispanic or Latino | 23 Participants | 25 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Overall Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Adolescents American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Adolescents Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Adolescents White | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers White | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) Overall American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Overall Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Overall Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Overall More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Overall Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Overall Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Overall White | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Adolescents Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Adolescents Male | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Caregivers Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Caregivers Male | 3 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Overall Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Overall Male | 13 Participants | 17 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 15 | 0 / 17 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (Control) | Fertility Preservation (FP) Uptake | 10 Participants |
| FP Decision Tool and Discussion (Treatment) | Fertility Preservation (FP) Uptake | 9 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Regret Mean | 1.9 Mean | Standard Deviation 1.6 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Satsifaction Mean | 5.9 Mean | Standard Deviation 1.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Information Mean | 6.3 Mean | Standard Deviation 1 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Time Mean | 4.6 Mean | Standard Deviation 2.6 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Involvement Mean | 6.1 Mean | Standard Deviation 1.5 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Right for You Mean | 3.9 Mean | Standard Deviation 2.5 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Involvement Mean | 6.8 Mean | Standard Deviation 0.7 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Regret Mean | 1.0 Mean | Standard Deviation 0 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Time Mean | 6.3 Mean | Standard Deviation 1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Satsifaction Mean | 5.3 Mean | Standard Deviation 2.5 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Right for You Mean | 5.4 Mean | Standard Deviation 1.4 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Information Mean | 6.3 Mean | Standard Deviation 1 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Regret | 1.7 Mean | Standard Deviation 1 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BDSQ Satisfaction | 5.7 Mean | Standard Deviation 1.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Information | 6.1 Mean | Standard Deviation 2 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Time | 5.7 Mean | Standard Deviation 2 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Involvement | 6.5 Mean | Standard Deviation 1.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Right for you | 4.6 Mean | Standard Deviation 1.7 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Involvement | 5.9 Mean | Standard Deviation 2 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Regret | 1.1 Mean | Standard Deviation 0.3 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Time | 6.3 Mean | Standard Deviation 1.4 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BDSQ Satisfaction | 6.0 Mean | Standard Deviation 1.5 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Right for you | 5.7 Mean | Standard Deviation 1.7 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA | Adolescent BSDQ Information | 6.3 Mean | Standard Deviation 2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Regret | 2.6 Mean | Standard Deviation 2.2 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Satisfaction | 5.6 Mean | Standard Deviation 2 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Information | 5.7 Mean | Standard Deviation 2.1 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Time | 4.5 Mean | Standard Deviation 2.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Involvement | 5.5 Mean | Standard Deviation 2.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Right for you | 5.5 Mean | Standard Deviation 2.1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Involvement | 5.7 Mean | Standard Deviation 2 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Regret | 1.4 Mean | Standard Deviation 1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Time | 5.1 Mean | Standard Deviation 1.5 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Satisfaction | 5.7 Mean | Standard Deviation 2.2 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Right for you | 5.0 Mean | Standard Deviation 1.9 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Information | 5.7 Mean | Standard Deviation 2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Regret | 1.8 Mean | Standard Deviation 1.4 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Satisfaction | 5.4 Mean | Standard Deviation 1.8 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Information | 6.5 Mean | Standard Deviation 0.9 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Time | 3.8 Mean | Standard Deviation 2.6 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Involvement | 6.8 Mean | Standard Deviation 0.7 |
| Standard of Care (Control) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Right for you | 4.3 Mean | Standard Deviation 1.6 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Involvement | 5.9 Mean | Standard Deviation 1.8 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Regret | 1.4 Mean | Standard Deviation 1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Time | 4.8 Mean | Standard Deviation 1.9 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Satisfaction | 5.9 Mean | Standard Deviation 2.1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Right for you | 5.1 Mean | Standard Deviation 2.1 |
| FP Decision Tool and Discussion (Treatment) | Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver | Caregiver BSDQ Information | 7.0 Mean | Standard Deviation 0 |