Breast Cancer, Estrogen Deprivation Symptoms, Hot Flashes, Vaginal Dryness
Conditions
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.
Interventions
BEHAVIORALText message management prompts
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Breast cancer * Female * Completed primary breast cancer treatment * Age \<=45
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flash Frequency | 1 week | Median number of daily hot flashes over 4th week of study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Text message management prompts | 11 |
| Control Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness | 27 |
| Total | 38 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 27 Participants | 38 Participants |
| Region of Enrollment United States | 11 participants | 27 participants | 38 participants |
| Sex: Female, Male Female | 11 Participants | 27 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 27 |
| serious Total, serious adverse events | 0 / 11 | 0 / 27 |
Outcome results
Primary
Hot Flash Frequency
Median number of daily hot flashes over 4th week of study
Time frame: 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Hot Flash Frequency | 2.2 daily hot flashes |
| Control | Hot Flash Frequency | 1.4 daily hot flashes |