Fertility Preservation in Male AYA With Cancer
Primary Purpose
Infertility, Male
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FP Decision Tool and Discussion
Sponsored by
About this trial
This is an interventional other trial for Infertility, Male focused on measuring Cancer, Fertility Preservation, Parenthood
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care (Control)
FP Decision Tool and Discussion (Treatment)
Arm Description
Participants will receive a standard of care fertility consult.
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.
Outcomes
Primary Outcome Measures
Fertility Preservation (FP) Uptake
FP uptake
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04268004
First Posted
February 11, 2020
Last Updated
February 1, 2023
Sponsor
Leena Nahata
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04268004
Brief Title
Fertility Preservation in Male AYA With Cancer
Official Title
Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leena Nahata
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Cancer, Fertility Preservation, Parenthood
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants and the interventionist will not be blinded. Research staff will be blinded.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (Control)
Arm Type
No Intervention
Arm Description
Participants will receive a standard of care fertility consult.
Arm Title
FP Decision Tool and Discussion (Treatment)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FP Decision Tool and Discussion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fertility Preservation (FP) Uptake
Description
FP uptake
Time Frame
Baseline to before AYA begins treatment (generally within one to two weeks from baseline)
Secondary Outcome Measure Information:
Title
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Description
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
Title
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Description
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
Title
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Description
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
Title
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leena Nahata, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing individual participant data (IPD) with other researchers.
Citations:
PubMed Identifier
31407498
Citation
Nahata L, Morgan TL, Lipak KG, Clark OE, Yeager ND, O'Brien SH, Whiteside S, Audino A, Quinn GP, Gerhardt CA. Perceptions of participating in family-centered fertility research among adolescent and young adult males newly diagnosed with cancer: A qualitative study. Pediatr Blood Cancer. 2019 Nov;66(11):e27966. doi: 10.1002/pbc.27966. Epub 2019 Aug 12.
Results Reference
background
PubMed Identifier
33564937
Citation
Nahata L, Dattilo TM, Olsavsky AL, Lipak KG, Whiteside S, Yeager ND, Audino A, Klosky JL, Rausch J, Saraf A, O'Brien SH, Quinn GP, Gerhardt CA. Impact of a novel family-centered values clarification tool on adolescent sperm banking attempts at the time of a new cancer diagnosis. J Assist Reprod Genet. 2021 Jun;38(6):1561-1569. doi: 10.1007/s10815-021-02092-6. Epub 2021 Feb 10.
Results Reference
background
PubMed Identifier
34298773
Citation
Theroux CI, Hill KN, Olsavsky AL, Klosky JL, Yeager ND, Audino A, O'Brien SH, Quinn GP, Gerhardt CA, Nahata L. Satisfaction with Fertility Preservation Decisions among Adolescent Males with Cancer: A Mixed Methods Study. Cancers (Basel). 2021 Jul 16;13(14):3559. doi: 10.3390/cancers13143559.
Results Reference
background
PubMed Identifier
34333651
Citation
Nahata L, Olsavsky A, Dattilo TM, Lipak KG, Whiteside S, Yeager ND, Audino A, Rausch J, Klosky JL, O'Brien SH, Quinn GP, Gerhardt CA. Parent-Adolescent Concordance Regarding Fertility Perspectives and Sperm Banking Attempts in Adolescent Males With Cancer. J Pediatr Psychol. 2021 Oct 18;46(10):1149-1158. doi: 10.1093/jpepsy/jsab069.
Results Reference
background
PubMed Identifier
35171948
Citation
Stanek C, Theroux CI, Olsavsky AL, Hill KN, Rausch JR, O'Brien SH, Quinn GP, Gerhardt CA, Nahata L. Study protocol for fertility preservation discussions and decisions: A family-centered psychoeducational intervention for male adolescents and emerging adults newly diagnosed with cancer and their families. PLoS One. 2022 Feb 16;17(2):e0263886. doi: 10.1371/journal.pone.0263886. eCollection 2022.
Results Reference
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Fertility Preservation in Male AYA With Cancer
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