The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer

Hadji, Peyman; Blettner, Maria; Harbeck, Nadia; Jackisch, Christian; Lück, Hans-Joachim; Windemuth-Kieselbach, C.; Zaun, Silke; Kreienberg, R.

doi:10.1093/annonc/mds653

Cited by 118 publications

(120 citation statements)

References 22 publications

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“…At 1 year, there was no difference in the primary endpoint of compliance (88.5% vs. 88.8 %, respectively; P ¼ 0.81). Thus, provision of education materials did not increase adherence to adjuvant endocrine therapy (76).…”

Section: Clinical Trials To Improve Endocrine Therapy Adherencementioning

confidence: 86%

“…The Patient's Anastrozole Compliance to Therapy (PACT) program was a randomized, prospective, multicenter study designed to improve persistence and compliance to adjuvant endocrine therapy (76). In this trial, 4,844 patients were randomly assigned to standard therapy or standard therapy plus mailed educational materials including monthly reminders on persistence and additional letters and brochures.…”

Section: Clinical Trials To Improve Endocrine Therapy Adherencementioning

confidence: 99%

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Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings

Chlebowski

Kim

Haque

2014

Cancer Prevention Research

153

149

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Adherence to oral endocrine therapy in adjuvant breast cancer settings is a substantial clinical problem. To provide current perspective on adherence to oral endocrine therapies, a comprehensive literature review was conducted. In adjuvant trials, endocrine therapy adherence is relatively high with greater adherence for aromatase inhibitors compared with tamoxifen. In contrast, adherence to adjuvant therapy in clinical practice is relatively poor, with only about 50% of women successfully completing 5-year therapy. Importantly, good adherence (>80% use) has been associated with lower recurrence risk. Endocrine therapy adherence in primary breast cancer prevention trials parallels that seen in adjuvant trials. Factors associated with nonadherence include low recurrence risk perception, side effects, age extremes, medication cost, suboptimal patient-physician communication, and lack of social support. Few prospective studies have evaluated interventions designed to improve adherence. Interventions currently proposed reflect inferences from clinical trial procedures in which clinical contacts are commonly greater than in usual practice settings. In conclusion, for optimal breast cancer outcome, adherence to endocrine therapy must improve. Although general recommendations likely to improve adherence can be made based on clinical trial results and preliminary prospective trial findings, research specifically targeting this issue is needed to establish effective intervention strategies. Cancer Prev Res; 7(4); 378-87. Ó2014 AACR.

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Section: Clinical Trials To Improve Endocrine Therapy Adherencementioning

confidence: 86%

Section: Clinical Trials To Improve Endocrine Therapy Adherencementioning

confidence: 99%

Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings

Chlebowski

Kim

Haque

2014

Cancer Prevention Research

153

149

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“…Randomization was stratified for type of adjuvant AI medication (anastrozole or letrozole) and start of AI treatment (up to 6 weeks; and 6-13 weeks prior to randomization). EMs, developed in future science group www.futuremedicine.com conjunction with five patrons actively involved in patient advocacy and modeled on the previous PACT Program [16], were mailed to group B patients nine-times during the first year. The contents of these information letters were essentially defined by women who were themselves affected by breast cancer and who have for many years been involved in the area of patients' selfhelp.…”

Section: • • Trial Designmentioning

confidence: 99%

“…In these qualityof-life (QoL) analyses, compliance with initial AI therapy was used as an approximation of adherence, because switching from the initial AI to another AI or hormone therapy would result in a patient being defined as noncompliant. The primary outcome assessment of compliance was modeled on that used in the previous PACT Program [16]. At study start, and at 1-and 2-year follow-up, patients completed a questionnaire assessing compliance during the clinic visit.…”

Section: • • Trial Designmentioning

confidence: 99%

“…The CARIATIDE (NCT00681122) study was designed to determine whether the provision of educational materials (EMs) could improve patient compliance with adjuvant nonsteroidal AI therapy in a global, real-world setting. The study used a similar design to the PACT Program [16]. The preliminary analysis of 1-year results from the CARIATIDE study showed that the provision of EMs did not impact on compliance with AI, compliance with initial AI or persistence rates [17].…”

mentioning

confidence: 99%

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Does patient education work in breast cancer? Final results from the global CARIATIDE study

Markopoulos¹,

Neven

Tanner

et al. 2015

Future Oncol.

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Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

Graetz,

Hu,

Kocak

et al. 2024

JAMA Netw Open

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ImportanceAdjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor–positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.ObjectiveTo test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.Design, Setting, and ParticipantsThis nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.InterventionsParticipants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.Main Outcomes and MeasuresThe primary outcome was 1-year, electronic pillbox–captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.ResultsAmong 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, −3.3%; 95% CI, −11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, −5.7%; 95% CI, −13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, −1.23; 95% CI, −2.03 to −0.43; P = .003), including high-cost encounters (adjusted difference, −0.40; 95% CI, −0.67 to −0.14; P = .003), and office visits (adjusted difference, −0.82; 95% CI, −1.54 to −0.09; P = .03) over the previous 6 months compared with EUC participants.Conclusions and RelevanceThis RCT found that a remote monitoring app with alerts to the patient’s care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.Trial RegistrationClinicalTrials.gov Identifier: NCT03592771

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The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer

Abstract: Addition of EMs to standard therapy did not significantly affect compliance and persistence with adjuvant anastrozole. CLINICALTRIALS ID: NCT00555867.

Cited by 118 publications

References 22 publications

Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings

Adherence to Endocrine Therapy in Breast Cancer Adjuvant and Prevention Settings

Does patient education work in breast cancer? Final results from the global CARIATIDE study

Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer

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