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NCT02176083 · REGISTRY CONDITION SEARCH

Reproductive Health Survivorship Care Plan Pilot

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

Most young breast cancer patients 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 (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.

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

Hot Flash Frequency

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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 Criteria: * Breast cancer * Female * Completed primary breast cancer treatment * Age \<=45
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
    Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
    intervention Names
    1. Behavioral: Text message management prompts
    label
    Intervention
    type
    EXPERIMENTAL
  2. description
    Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
    label
    Control
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. Intervention
    name
    Text message management prompts
    type
    BEHAVIORAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
SINGLE
who Masked
  1. PARTICIPANT
primary Purpose
TREATMENT
Enrollment
count
38
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Median number of daily hot flashes over 4th week of study
    measure
    Hot Flash Frequency
    time Frame
    1 week
Full study description
brief Summary
Most young breast cancer patients 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 (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-024e512a7b83b9538978
      requested nct id
      NCT02176083
      primary nct id
      NCT02176083
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
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      payload sha256
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      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-024e512a7b83b9538978
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02176083
      occurrences
      1. context exact
        NCT02176083
        end
        11
        exact text
        NCT02176083
        start
        0
      offset unit
      unicode_code_points
      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
      source file sha256
      b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
      source json pointer
      /studies/26/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      33ea7464fb7705aa2638ebb89d87b5a47983af4925c7f2417a8758e1d34e207c

    Preserved source evidence · Not medical advice