N/A
N=182
Reproductive Health Survivorship Care Plan
Breast Cancer · Hot Flashes · Sexual Dysfunction · Fertility · Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02667626 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With a 50% Decrease in Hot Flash Score — 50; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reproductive Health Survivorship Care Plan (SCPR) (Other); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 50% Decrease in Hot Flash Score |
50; 53 | — |
| PRIMARY Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3 |
24; 14 | — |
| PRIMARY Number of Participants Using a WHO Class I or II Contraception |
43; 41 | — |
| PRIMARY Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score |
37; 39 | — |
| SECONDARY Healthcare Provider Preparedness Scale |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02667626). 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.