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
Accrual
100%
Abbreviated Title
Text Messaging Study
Activated
03/27/2012
Closed
09/15/2013
Participants
NCORP, Members, Medical Oncologists, Affiliates

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

2021

Patient Reported Outcomes and Long-Term Non-Adherence to Aromatase Inhibitors

D Hershman;A Neugut;A Moseley;K Arnold;J Gralow;NL Henry;G Clarke Hillyer;S Ramsey;J Unger Journal of the National Cancer Institute Feb 25:djab022, 2021. doi: 10.1093/jnci/djab022. Online ahead of print.

PMid: PMID33629114

2020

Randomized Trial of Text-Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women with Early Stage Breast Cancer: SWOG S1105

DL Hershman;JM Unger;G Clarke Hillyer;A Moseley;K Arnold;S Dakhil;B Esparaz;M Kuan;ML Graham;D Lackowski;W Edenfield;Z Dayao;NL Henry;J Gralow;S Ramsey;A Neugut Journal of Clinical Oncology Jul 1;38(19):2122-2129; May 5;JCO1902699. doi: 10.1200/JCO.19.02699. Online ahead of print.

PMid: PMID32369401 | PMC number: PMC7325363

Predictive Model of Aromatase Inhibitor Non-Adherence Using Patient-Reported Outcomes in Women with Breast Cancer (SWOG S1105)

D Hershman;A Moseley;K Arnold;G Hillyer;J Gralow;NL Henry;A Neugut;S Ramsey;J Unger J Clin Oncol 38: 2020 (suppl; abstr 12019); American Society of Clinical Oncology 2020 Annual Meeting, poster discussion

2019

Randomized Trial of Text-Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women with Early Stage Breast Cancer: SWOG S1105, NCT01515800

D Hershman;J Unger;G Clarke Hillyer;A Moseley;K Arnold;S Dakhil;B Esparaz;M Kuan;ML Graham;D Lackowski;W Edenfield;Z Dayao;J Gralow;S Ramsey;A Neugut J Clin Oncol 37(suppl; abstr 6516); American Society of Clinical Oncology (5/31/2019 - 6/4/2019, Chicago IL), oral

Baseline Factors Associated with Aromatase Inhibitor Adherence Failure among Women in Enrolled in a Randomized Trial of Text-Messaging: SWOG S1105

DL Hershman;JM Unger;A Moseley;G Clarke Hillyer;K Arnold;JR Gralow;NL Henry;S Ramsey;A Neugut San Antonio Breast Cancer Symposium (Dec 10-14, 2019, San Antonio, TX), poster, spotlight session