Reproductive Health Survivorship Care Plan Pilot

NCT ID: NCT02176083

Last Updated: 2020-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-20

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Hot Flashes Vaginal Dryness Estrogen Deprivation Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness

Group Type EXPERIMENTAL

Text message management prompts

Intervention Type BEHAVIORAL

Control

Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text message management prompts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Breast cancer
* Female
* Completed primary breast cancer treatment
* Age \<=45
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Hui-Chun Irene Su

Assistant Professor of Reproductive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Su, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

UC San Diego

Locations

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UC San Diego

La Jolla, California, United States

Site Status

UCSD Moores Cancer Center

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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SCP-1

Identifier Type: -

Identifier Source: org_study_id

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