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NCT02176083

Reproductive Health Survivorship Care Plan Pilot

Completed NA Results posted Last updated 20 April 2020
What this trial tests

NA trial testing Text message management prompts in Breast Cancer in 38 participants. Completed in 31 December 2015.

Timeline
20 March 2014
Primary endpoint
31 August 2014
31 December 2015

Quick facts

Lead sponsorUniversity of California, San Diego
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment38
Start date20 March 2014
Primary completion31 August 2014
Estimated completion31 December 2015
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

Adults 18 to 45, female only, with Breast Cancer or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hot Flash Frequency Primary · 1 week

Median number of daily hot flashes over 4th week of study

GroupValue95% CI
Intervention2.21.2 – 3.6
Control1.40.7 – 2.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other University of California, San Diego trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02176083.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing