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S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
S1105, Randomized Trial Of Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
 
Region Sponsors
California - Northern
Southwest Oncology Group
 
Acronym KP IRB No.
CN-12LFehr-17-B
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Breast Cancer
 
Purpose
RATIONALE: Measuring how text-message affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This randomized trial studies how well text-message works in reducing early discontinuation of aromatase inhibitor therapy in patients with early-stage breast cancer who underwent breast surgery.
 
Detailed Description
 
Gender Age Limit
Female 18 years & older
 
Inclusion Criteria
  • Patients must be women with a diagnosis of histologically confirmed, primary invasive, hormone-sensitive (estrogen receptor-positive [ER]/progesterone receptor [PR]-positive) adenocarcinoma of the breast (Stage I, II or III) with no evidence of recurrent or metastatic disease (M0)
  • Patients must have a mobile phone that can receive text messages and must currently use or be willing to learn to use text messaging
  • Patients must be postmenopausal, as defined by at least one of the following: >/= 12 months since the last menstrual period, Prior bilateral oophorectomy, or Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the postmenopausal state. FSH levels must be obtained within 28 days prior to registration
  • Patients must be willing to provide urine specimen to test for the presence of aromatase inhibitor within 28 days of randomization and at each 3-month clinic visit for 3 years
  • Patients must have the ability to speak and read English Patients must have a Zubrod performance status of 0 - 2 No other prior malignancy (i.e., other than as noted on disease characteristics) is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 years
  • Patients are allowed to participate in another clinical trial as long as it does not interfere with daily intake of aromatase-inhibitor therapy
  • Please contact study coordinator for more inclusion criteria
 
Exclusion Criteria
  • Insufficient evidence of post-menopausal status
  • metastatic or recurrent disease
  • currently receiving chemotherapy.

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
  • Females - Postmenopausal
 
KP Clinical Facility
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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