Reproductive Health Survivorship Care Plan

NCT02667626 | Completed Results

• 1 other identifier: 140863
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Breast cancer survivor; Cancer survivorship; Survivorship care plan; Vaginal dryness; Vulvovaginal atrophy; Vasomotor symptom; Infertility; Family planning

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Healthcare Provider Preparedness Scale

  24 weeks

Other Outcomes (6)

• Depression (PHQ-8)

  12 and 24 weeks

• Social Support (MOS Social Support)

  12 and 24 weeks

• Insomnia Scale

  12 and 24 weeks

Study Arms (2)

SCPR Intervention

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

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.

SCPR Intervention

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant at recruitment

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093-0901, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Sexual Dysfunction, Physiological; Infertility

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Irene Su, MD MSCE
• Organization: University of California, San Diego

hisu@ucsd.edu

8588225986

Study Officials

• H. Irene Su, MD MSCE

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 29, 2016
• Study Start: March 25, 2015
• Primary Completion: December 31, 2017
• Study Completion: January 24, 2019
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)