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Fertility Preservation Discussion for Cancer
N/A
Waitlist Available
Led By Leena Nahata, MD
Research Sponsored by Leena Nahata
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed cancer
Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post randomization
Awards & highlights
Study Summary
This trial is testing whether having a guided conversation about fertility preservation with an expert increases the rates of fertility preservation and/or satisfaction with the decision among adolescent and young adult males with cancer.
Who is the study for?
This trial is for young males aged 12-25 with a new cancer diagnosis who are about to start treatment that could affect fertility. They must understand English and be at a certain stage of puberty to bank sperm. It's not for those with cognitive issues or non-English speaking parents.Check my eligibility
What is being tested?
The study tests if a special tool and conversation about sperm banking before cancer treatment can help increase the number of young men preserving their fertility and improve satisfaction with their decision, compared to just getting routine fertility advice.See study design
What are the potential side effects?
Since this trial involves discussions rather than medical treatments, there are no direct physical side effects. However, participants may experience emotional or psychological impacts from conversations about fertility preservation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to undergo additional therapy after my initial cancer treatment.
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I am male.
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I am in puberty and eligible for sperm banking.
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I am between 12 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fertility Preservation (FP) Uptake
Secondary outcome measures
Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA
Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FP Decision Tool and Discussion (Treatment)Experimental Treatment1 Intervention
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.
Group II: Standard of Care (Control)Active Control1 Intervention
Participants will receive a standard of care fertility consult.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
Leena NahataLead Sponsor
Leena Nahata, MDPrincipal InvestigatorNationwide Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am expected to undergo additional therapy after my initial cancer treatment.I am male.I am in puberty and eligible for sperm banking.Your parents do not speak English.I am between 12 and 25 years old.I have difficulty with thinking or memory that makes it hard for me to complete tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (Control)
- Group 2: FP Decision Tool and Discussion (Treatment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation accept participants that are over four decades old?
"This scientific trial necessitates that all participants are between the ages of 12 and 25. 14 studies accept patients younger than 18, while 34 studies permit those over 65 years old to join their study."
Answered by AI
Is this trial currently accepting participants?
"The clinical trial that was initially posted on January 1st 2021 is not accepting applications at this time, as evidenced by the information available from clinicaltrials.gov's database. However, there are still 245 other trials actively seeking patients for enrollment in their studies."
Answered by AI
Who meets the criteria to be a participant in this medical trial?
"This clinical trial is seeking 40 male patients aged between 12 and 25 with sterility. In addition to these requirements, participants must be suitable for adjuvant therapy (chemotherapy/radiation treatment) as determined by a fertility consult, have entered puberty (Tanner stage 2-3), and are eligible for sperm banking."
Answered by AI
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