Reproductive Health Survivorship Care Plan Pilot

University of California San Diego

Status: Completed

Conditions: Breast Cancer; Vaginal Dryness; Hot Flashes; Estrogen Deprivation Symptoms

Treatments: Behavioral: Text message management prompts

Study type: Interventional

Funder types: Other

Identifiers

NCT02176083

SCP-1

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Breast cancer
• Female
• Completed primary breast cancer treatment
• Age <=45

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Text message management prompts

Control

No Intervention group

Description:

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