Have you or your loved ones been diagnosed with breast cancer?

You may be eligible to participate in a breast cancer clinical trial.

Have you or your loved ones been diagnosed with breast cancer? You may be eligible to participate in a breast cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Breast Cancer Clinical Trial in La Jolla CA

NCT02667626 | Interventional

Have you or your loved ones been diagnosed with breast cancer?

You may be eligible to participate in a breast cancer clinical trial.

Have you or your loved ones been diagnosed with breast cancer? You may be eligible to participate in a breast cancer clinical trial.

Completed

Female

18 - 45

Years old

This study has recruited 182 Participants

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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Details for the study

Brief Title

Reproductive Health Survivorship Care Plan

Official Title

Intervening on Reproductive Health in Young Breast Cancer Survivors

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.

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.

Treatments and/or Procedures

Control

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

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

Primary

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

Primary

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

Primary

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

Secondary

Healthcare Provider Preparedness Scale

Change in score

24 weeks

Other

Menopause Quality of Life (MENQOL)

Change in score

12 and 24 weeks

Other

Confidence for Managing Reproductive Health Issues Scale

Change in score

12 and 24 weeks

Other

Female Sexual Function Inventory

Change in score

12 and 24 weeks

Other

Insomnia Scale

Change in score

12 and 24 weeks

Other

Depression (PHQ-8)

Change in score

12 and 24 weeks

Other

Social Support (MOS Social Support)

Change in score

12 and 24 weeks

Study 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