Clinical trial · Interventional
Reproductive Health Survivorship Care Plan Pilot
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)
Most young breast cancer patients 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 (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.
Conditions
Conditions (4)
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 |
| Estrogen Deprivation Symptoms | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Vaginal Dryness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Text message management prompts | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
- interventionNames
- Behavioral: Text message management prompts
- type
- NO_INTERVENTION
- label
- Control
- description
- Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
Primary outcomes (1)
- measure
- Hot Flash Frequency
- timeFrame
- 1 week
- description
- Median number of daily hot flashes over 4th week of study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer * Female * Completed primary breast cancer treatment * Age \<=45
References
Publications (0)
Data not yet available