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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness |
|
| Control | No Intervention | Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message management prompts | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hot Flash Frequency | Median number of daily hot flashes over 4th week of study | 1 week |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Su, MD MSCE | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093-0901 | United States | ||
| UCSD Moores Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness Text message management prompts |
| FG001 | Control | Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness Text message management prompts |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hot Flash Frequency | Median number of daily hot flashes over 4th week of study | Posted | Median | Inter-Quartile Range | daily hot flashes | 1 week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness Text message management prompts |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene Su, MD MSCE | University of California, San Diego | 8588225986 | hisu@ucsd.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| La Jolla |
| California |
| 92093 |
| United States |
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control | Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness | 0 | 27 | 0 | 27 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |