N/A
Completed N=98
Pilot Study of a Decision Aid Intervention for Family-building After Cancer
Source: ClinicalTrials.gov NCT04059237 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Measure Decision Conflict Scale — 52.25; 36.86; 34.55 score on a scale — p=<0.001
Summary
This study tests a web-based decision aid and planning too to help young female cancer survivors manage fertility and family-building issues in post treatment survivorship.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Decision Conflict Scale |
52.25; 36.86; 34.55 | <0.001 sig |
| SECONDARY Fertility Information Needs |
3.39; 2.02; 2.09 | <.001 sig |
| SECONDARY Measure Illness Perceptions Questionnaire-Revised (IPQ-R) |
85.66; 81.48; 81.64 | <0.001 sig |
| SECONDARY Measure Reproductive Concerns After Cancer (RCAC) Scale |
64.14; 61.55; 60.94 | 0.10 |
| SECONDARY Measure Impact of Events Scale-Revised (IES-R) |
1.34; 1.10; 1.03 | .01 sig |
| SECONDARY Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale |
3.83; 3.91; 3.89 | 0.59 |
| SECONDARY Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale |
2.95; 3.31; 3.26 | 0.02 sig |
| SECONDARY Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale |
3.23; 3.32; 3.27 | 0.52 |
| SECONDARY Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale |
2.70; 2.92; 2.92 | 0.08 |
Eligibility Criteria
Inclusion Criteria
- Female
- Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
- Understands verbal and written English
- Desires future children or uncertainty regarding family-building plans
- Access to the Internet and use of a computer, tablet, or smartphone
Exclusion Criteria
- Currently undergoing cancer treatment excluding long-term adjuvant or maintenance therapies, such as tamoxifen
- Significant physical or mental disability that prevents completion of study activities
Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.
Data sourced from ClinicalTrials.gov (NCT04059237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.