Clinical trial · Interventional
Reproductive Health Survivorship Care Plan
Intervening on Reproductive Health in Young Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Contraception | — | UNRESOLVED | — |
| Fertility | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Reproductive Health Survivorship Care Plan (SCPR) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCPR Intervention
- description
- Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.
- interventionNames
- Other: Reproductive Health Survivorship Care Plan (SCPR)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion: * Breast cancer (Stages 0-III) diagnosis * Breast cancer diagnosis age ≤ 45 years * ≤ 5 years since breast cancer diagnosis * Current age 18 to 50 years * Completed treatment with surgery, radiation and chemotherapy (if applicable) * Able to read English * Able to consent to the study * Access to an Internet connection Exclusion: • Women who are pregnant at recruitment
References
Publications (1)
- DERIVEDShliakhtsitsava K, Stark SS, Prasad T, Boles S, Chingos D, Ehren J, Gorman JR, Romero SAD, Mao JJ, Nathan P, Armenian SH, Su HI. Impact of a Reproductive Health Survivorship Care Plan on Fertility, Pregnancy Concerns, and Accessing Reproductive Healthcare Among Young Nulliparous Breast Cancer Survivors. Cancer Rep (Hoboken). 2026 Jan;9(1):e70433. doi: 10.1002/cnr2.70433. PMID 41505735