NCT02667626

Reproductive Health Survivorship Care Plan

Intervening on Reproductive Health in Young Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study. YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks. Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions. All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues. Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.

Conditions

• Breast Cancer
• Hot Flashes
• Sexual Dysfunction
• Fertility
• Contraception

Interventions

Type	Name	Description
OTHER	Reproductive Health Survivorship Care Plan (SCPR)	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.
OTHER	Control	Web-based resource lists and text-based study adherence reminders

Timeline

• Start date: 2015-03-25
• Primary completion: 2017-12-31
• Completion: 2019-01-24
• First posted: 2016-01-29
• Last updated: 2020-04-20
• Results posted: 2020-04-20

Locations

1 site across 1 country: United States