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NCT02667626 · REGISTRY CONDITION SEARCH

Reproductive Health Survivorship Care Plan

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2020-04-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Number of Participants Using a WHO Class I or II Contraception

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outcome · POSTED

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

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outcome · POSTED

Healthcare Provider Preparedness Scale

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outcome · NOT POSTED

Depression (PHQ-8)

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outcome · NOT POSTED

Social Support (MOS Social Support)

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outcome · NOT POSTED

Insomnia Scale

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outcome · NOT POSTED

Female Sexual Function Inventory

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outcome · NOT POSTED

Confidence for Managing Reproductive Health Issues Scale

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outcome · NOT POSTED

Menopause Quality of Life (MENQOL)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
45 Years
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Other: Reproductive Health Survivorship Care Plan (SCPR)
    label
    SCPR Intervention
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Other: Control
    label
    Control
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. SCPR Intervention
    description
    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.
    name
    Reproductive Health Survivorship Care Plan (SCPR)
    type
    OTHER
  2. arm Group Labels
    1. Control
    description
    Web-based resource lists and text-based study adherence reminders
    name
    Control
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
182
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Change in score
    measure
    Depression (PHQ-8)
    time Frame
    12 and 24 weeks
  2. description
    Change in score
    measure
    Social Support (MOS Social Support)
    time Frame
    12 and 24 weeks
  3. description
    Change in score
    measure
    Insomnia Scale
    time Frame
    12 and 24 weeks
  4. description
    Change in score
    measure
    Female Sexual Function Inventory
    time Frame
    12 and 24 weeks
  5. description
    Change in score
    measure
    Confidence for Managing Reproductive Health Issues Scale
    time Frame
    12 and 24 weeks
  6. description
    Change in score
    measure
    Menopause Quality of Life (MENQOL)
    time Frame
    12 and 24 weeks
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With a 50% Decrease in Hot Flash Score
    time Frame
    Baseline and 24 weeks
  2. description
    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.
    measure
    Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3
    time Frame
    24 weeks
  3. description
    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)
    measure
    Number of Participants Using a WHO Class I or II Contraception
    time Frame
    24 weeks
  4. description
    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.
    measure
    Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score
    time Frame
    Baseline and 24 weeks
secondary Outcomes
  1. description
    Change in score
    measure
    Healthcare Provider Preparedness Scale
    time Frame
    24 weeks
Full study description
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.
Source references
references
  1. citation
    Shliakhtsitsava K, Stark SS, Prasad T, Boles S, Chingos D, Ehren J, Gorman JR, Romero SAD, Mao JJ, Nathan P, Armenian SH, Su HI. Impact of a Reproductive Health Survivorship Care Plan on Fertility, Pregnancy Concerns, and Accessing Reproductive Healthcare Among Young Nulliparous Breast Cancer Survivors. Cancer Rep (Hoboken). 2026 Jan;9(1):e70433. doi: 10.1002/cnr2.70433.
    pmid
    41505735
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
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      query disease state id
      ds-vaginal-cancer
      source file
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    Preserved source evidence · Not medical advice