SWOG clinical trial number
S1105
Randomized Trial Of A Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
Closed
Phase
Accrual
100%
Abbreviated Title
Text Messaging Study
Activated
03/27/2012
Closed
09/15/2013
Participants
Research committees
Cancer Care Delivery
Breast Cancer
Eligibility Criteria Expand/Collapse
Patients must be women (age >/= 18 yrs). with a diagnosis of histologically confirmed, primary invasive, hormone-sensitive (either ER or PR positive or both) adenocarcinoma of the breast (Stage I, II or III) with no evidence of recurrent or metastatic disease (M0); must be post adjuvant chemotherapy (if to be utilized) and post primary curative surgery and must have recovered from all side-effects of the surgery. (Note Herceptin given alone after cytotoxic chemotherapy is considered adjuvant chemotherapy. Patients would be eligible upon completion of Herceptin as long as the other eligibility criteria are met); patients must be postmenopausal, as defined by at least one of the following: >/= 12 months since the last menstrual period OR 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 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 currently taking an aromatase inhibitor (AI), have completed at least 30 days of AI therapy, be within the first 2 years of planned AI therapy; if prior tamoxifen was received, total hormonal therapy, including tamoxifen and AI therapy, must have started within 2 years; patient must have at least 3 years of AI therapy remaining; total planned AI therapy must be at least 5 years duration; Patients must have a mobile phone that can receive text messages and must currently use or be willing to learn to use text messaging; Participation is limited to patients who use one of the U.S. carriers listed in the protocol. Patients must be willing to provide urine specimen to test for the presence of aromatase inhibitor after randomization but prior to beginning intervention and at each 3 month clinic visit for 3 years; Patients must have the ability to read English or Spanish and have a Zubrod Performance Status of 0- 2; May participate in another clinical trial as long it does not interfere with daily intake of AI therapy; No other prior malignancy 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.
Publication Information Expand/Collapse
2023
Sociodemographic risk factors and prediction of aromatase inhibitor non-adherence in women with breast cancer enrolled in SWOG S1105
2021
Patient Reported Outcomes and Long-Term Non-Adherence to Aromatase Inhibitors
PMid: PMID33629114 | PMC number: PMC8328987
2020
PMid: PMID32369401 | PMC number: PMC7325363
2019
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Research Committee(s)
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Activated
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Phase