CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 182 enrolled
Drug / intervention
Reproductive Health Survivorship Care Plan (SCPR) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02667626
NCT02667626N/ACompleted

Intervening on Reproductive Health in Young Breast Cancer Survivors

University of California, San Diego·interventional·Posted Jan 29, 2016·Updated Apr 20, 2020

In Brief

A clinical study evaluating Reproductive Health Survivorship Care Plan (SCPR) and Control for Breast Cancer and 4 related conditions. Completed, enrolled 182 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 29, 2016
Enrollment StartMar 25, 2015
Primary CompletionDec 31, 2017
Study CompletionJan 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.4 years ago

Interventions

Reproductive Health Survivorship Care Plan (SCPR)other

The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Controlother

Web-based resource lists and text-based study adherence reminders