Reproductive Health Survivorship Care Plan (SCPR)

Intervening on Reproductive Health in Young Breast Cancer Survivors

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Hot Flashes; Sexual Dysfunction; Contraception; Fertility
• Intervention / Treatment: Other: Reproductive Health Survivorship Care Plan (SCPR); Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0901
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCPR Intervention; 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.	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.
Active Comparator: Control; 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.	Other: Control; Web-based resource lists and text-based study adherence reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a 50% Decrease in Hot Flash Score	50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.	Baseline and 24 weeks
Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3	Fertility concerns subscale score <=3. Scores for the fertility subscale calculated by averaging responses (range 1-5) to the 3 subscale questions. The minimum score is 1, the maximum score is 5, Higher scores indicate worse outcome.	24 weeks
Number of Participants Using a WHO Class I or II Contraception	Use of World Health Organization Class I or II contraceptive methods (intrauterine devices, female sterilization, male partner sterilization, combined hormonal contraception, progestin implants or injections)	24 weeks
Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score	The Vulvovaginal Atrophy Score is a 4-item scale on vaginal dryness, soreness, irritation and dyspareunia experienced in the prior 4 weeks]. Each item has a 4-point Likert scale response (0-none, 1-mild, 2-moderate, 3-severe). The scale is summarized by averaging responses, with higher scores indicating a greater level of vaginal atrophy.	Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Provider Preparedness Scale	Change in score	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression (PHQ-8)	Change in score	12 and 24 weeks
Social Support (MOS Social Support)	Change in score	12 and 24 weeks
Insomnia Scale	Change in score	12 and 24 weeks
Female Sexual Function Inventory	Change in score	12 and 24 weeks
Confidence for Managing Reproductive Health Issues Scale	Change in score	12 and 24 weeks
Menopause Quality of Life (MENQOL)	Change in score	12 and 24 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: H. Irene Su, MD MSCE, UC San Diego

Study record dates

Study Major Dates

• Study Start: March 25, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Infertility; Breast cancer survivor; Vulvovaginal atrophy; Vaginal dryness; Cancer survivorship; Survivorship care plan; Vasomotor symptom; Family planning
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hot Flashes
• Other Study ID Numbers: 140863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Interested investigators may apply for deidentified data from this study