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Completed

NCT Number: NCT02667626

Reproductive Health Survivorship Care Plan

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Contraception Fertility Genital Diseases Hot Flashes Infertility Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093-0901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Other

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

Primary outcomes

  1. Number of Participants With a 50% Decrease in Hot Flash Score

    Time frame: Baseline and 24 weeks

    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.

  2. Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3

    Time frame: 24 weeks

    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.

  3. Number of Participants Using a WHO Class I or II Contraception

    Time frame: 24 weeks

    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)

  4. Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score

    Time frame: Baseline and 24 weeks

    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.

Secondary outcomes

  1. Healthcare Provider Preparedness Scale

    Time frame: 24 weeks

    Change in score

Other outcomes

  1. Depression (PHQ-8)

    Time frame: 12 and 24 weeks

    Change in score

  2. Social Support (MOS Social Support)

    Time frame: 12 and 24 weeks

    Change in score

  3. Insomnia Scale

    Time frame: 12 and 24 weeks

    Change in score

  4. Female Sexual Function Inventory

    Time frame: 12 and 24 weeks

    Change in score

  5. Confidence for Managing Reproductive Health Issues Scale

    Time frame: 12 and 24 weeks

    Change in score

  6. Menopause Quality of Life (MENQOL)

    Time frame: 12 and 24 weeks

    Change in score

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Intervening on Reproductive Health in Young Breast Cancer Survivors

Acronym: SCPR

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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