Helping female childhood cancer survivors with fertility concerns
Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer
This study is trying out a new program to help female childhood cancer survivors understand their fertility options and feel less anxious about them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06834945 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and refine a behavioral intervention designed to address fertility-related information needs and distress among female adult survivors of childhood cancer. It will utilize a structured approach based on the Obesity-Related Behavioral Intervention Trials (ORBIT) Model, delivering six remote sessions that incorporate patient activation theory and Acceptance and Commitment Therapy (ACT) strategies. The intervention will focus on empowering participants to make informed decisions regarding their fertility by enhancing their knowledge and reducing distress. A small sample of 30 participants will be involved to assess the feasibility and acceptability of the intervention, as well as changes in key outcomes such as fertility health knowledge and psychological flexibility.
Who should consider this trial
Good fit: Ideal candidates for this study are female adult survivors of childhood cancer aged 18-44 who are uncertain about their fertility status.
Not a fit: Patients currently under the care of a fertility specialist or those with major psychiatric concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the fertility-related knowledge and emotional well-being of female survivors of childhood cancer.
How similar studies have performed: While this approach is novel in its specific focus, similar behavioral interventions have shown promise in addressing fertility concerns in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently aged 18-44 * Diagnosed with cancer at \<18 years old * Female sex * Uncertain fertility status Exclusion Criteria: * Age \<18 * Currently under the care of a fertility specialist * Having a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider * Inability to provide consent.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Juliann Stalls, PhD
- Email: juliann.stalls@duke.edu
- Phone: 919-416-3417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.