Does Patient Education Work in Breast Cancer?
Does Patient Education Work in Breast Cancer?
The study enrolled postmenopausal women with HR early-stage breast cancer without metastases. Eligible patients were required to have been prescribed an adjuvant nonsteroidal AI (anastrozole or letrozole) according to the current Summary of Product Characteristics for less than 13 weeks at enrollment. Patients were excluded if they had: previously participated in any clinical study assessing hormonal treatments for breast cancer; received adjuvant anastrozole or letrozole exceeding 13 weeks at the time of randomization; received concomitant tamoxifen or exemestane treatment; or previous treatment with either medication for a period exceeding 13 weeks. Tumor stage was not evaluated in this study.
This was an international, multicenter, randomized, parallel-group, observational study initiated in May 2008 and conducted in 248 centers across 18 countries worldwide. Patients were randomized, using the Interactive Web Response System, 1:1 to standard AI treatment (group A) or standard AI treatment plus EMs (group B). 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 conjunction with five patrons actively involved in patient advocacy and modeled on the previous PACT Program, 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' self-help. The main purpose of the letters was to motivate the participating women to take their medication on a regular basis. Additionally, brochures were provided that dealt with issues of particular relevance to the patients at specific points in time during therapy. Briefly, the EMs comprised: 'Welcome pack' (week 1); 'Benefits, side effects, convenience' (week 2); 'A patient journey' (week 4); 'Fatigue and lymphedema' (week 6); 'Communication' (week 8); 'Anxiety' (week 12); 'Intimacy and sexuality' (month 5); 'Exercise and diet' (month 7), and 'Enjoying life and positive approach for future' (month 10). Notably, in line with the study aim of improving patient compliance, the 'Welcome pack' brochure (week 1) provided an introduction to the risk of breast cancer relapse, the different types of anti-hormone therapies available and practical tips on remembering to take tablets daily. Patients were told that by taking their tablets as prescribed, they reduced their risk of relapse and that if they stopped taking the medication, this would affect their risk of relapse. Further information is available in the Supplementary Material http://www.futuremedicine.com/doi/suppl/10.2217/fon.14.179/suppl_file/suppl_material.docx (see online at www.futuremedicine.com/doi/suppl/10.2217/fon.14.179). Timings of EM distribution were based on clinical experience of when patients would typically require support for issues, such as side effects.
The EMs were sent to each participating country for review and translation to allow for changes to address local country needs. All brochures, once translated, were returned to the lead country (Belgium) and printed to produce the final versions. Investigators confirmed all patients from group B had received and read the EMs at study follow-up by asking the question 'Have you read the educational material?' All patients included in the analysis provided informed consent. Patients were followed up at 1 year (±8 weeks) and 2 years (±8 weeks) in accordance with standard clinical care, and as deemed appropriate according to local country practice. The study was performed in accordance with the Declaration of Helsinki and approved by the relevant ethical committees.
The primary objective was to assess and compare the 1-year compliance rate across the two observational arms, based on patient assessment. The secondary objectives were to assess and compare across the two observational arms: compliance at 1 year (investigator assessment) and 2 years (investigator and patient assessments); persistence at 1 and 2 years (investigator assessment); time to discontinuation of adjuvant AI medication; and reasons for adjuvant AI treatment discontinuation.
Patients were considered to be compliant to adjuvant AI if they did not switch from any AI to tamoxifen. If a patient switched from the initial AI to another AI or hormone therapy, they were deemed to be noncompliant. A sensitivity analysis was performed to determine patient compliance with initial AI; patients who did not switch from the initial AI to another AI or any other hormone therapy were considered compliant to initial AI. Patients were classified as persistent users if they did not switch AI medication and AI medication was not discontinued.
Exploratory end points (assessed at 1 year and 2 years) included assessment of the impact of parameters that may have an influence on adjuvant AI treatment compliance and persistence (including demographic and other baseline characteristics, employment status, education, early-stage breast cancer history and therapies), and patient- and investigator-reported outcome variables: the Functional Assessment of Breast Cancer Therapy – Endocrine Symptoms subscale (FACT-ES) in countries where validated translations of the questionnaire exist; the 12-item General Health Questionnaire (GHQ-12); and the European Organization for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire (EORTC IN-PATSAT-32) for patients and investigators. In these quality-of-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. At study start, and at 1- and 2-year follow-up, patients completed a questionnaire assessing compliance during the clinic visit. The primary outcome variable was self-assessed using the following question:
Answers were graded as: 0–5 (Table 1). Patients were defined as compliant if they scored 5 or 6 (≥80%); scores between 0 and 4 led to a noncompliant classification. Physician-reported compliance was based on the number of prescriptions written in the previous year.
Persistence was evaluated at 1 and 2 years by the following question asked by the investigator:
Patients were defined as persistent if they answered 'Yes' and investigator-documented case report form (CRF) data supported persistent intake of adjuvant AI medication since last study visit. Discontinuation was assessed over the 2 years follow-up. Time to treatment discontinuation was defined as number of days between date of first and last intake of AI medication. If a patient discontinued study treatment during the first year and the second year, only the last discontinuation was taken into account. All discontinuations and the reasons were recorded. The number of patients switching treatment was recorded, but no additional information such as reasons for switch was collected.
Patients & Methods
Participants
The study enrolled postmenopausal women with HR early-stage breast cancer without metastases. Eligible patients were required to have been prescribed an adjuvant nonsteroidal AI (anastrozole or letrozole) according to the current Summary of Product Characteristics for less than 13 weeks at enrollment. Patients were excluded if they had: previously participated in any clinical study assessing hormonal treatments for breast cancer; received adjuvant anastrozole or letrozole exceeding 13 weeks at the time of randomization; received concomitant tamoxifen or exemestane treatment; or previous treatment with either medication for a period exceeding 13 weeks. Tumor stage was not evaluated in this study.
Trial Design
This was an international, multicenter, randomized, parallel-group, observational study initiated in May 2008 and conducted in 248 centers across 18 countries worldwide. Patients were randomized, using the Interactive Web Response System, 1:1 to standard AI treatment (group A) or standard AI treatment plus EMs (group B). 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 conjunction with five patrons actively involved in patient advocacy and modeled on the previous PACT Program, 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' self-help. The main purpose of the letters was to motivate the participating women to take their medication on a regular basis. Additionally, brochures were provided that dealt with issues of particular relevance to the patients at specific points in time during therapy. Briefly, the EMs comprised: 'Welcome pack' (week 1); 'Benefits, side effects, convenience' (week 2); 'A patient journey' (week 4); 'Fatigue and lymphedema' (week 6); 'Communication' (week 8); 'Anxiety' (week 12); 'Intimacy and sexuality' (month 5); 'Exercise and diet' (month 7), and 'Enjoying life and positive approach for future' (month 10). Notably, in line with the study aim of improving patient compliance, the 'Welcome pack' brochure (week 1) provided an introduction to the risk of breast cancer relapse, the different types of anti-hormone therapies available and practical tips on remembering to take tablets daily. Patients were told that by taking their tablets as prescribed, they reduced their risk of relapse and that if they stopped taking the medication, this would affect their risk of relapse. Further information is available in the Supplementary Material http://www.futuremedicine.com/doi/suppl/10.2217/fon.14.179/suppl_file/suppl_material.docx (see online at www.futuremedicine.com/doi/suppl/10.2217/fon.14.179). Timings of EM distribution were based on clinical experience of when patients would typically require support for issues, such as side effects.
The EMs were sent to each participating country for review and translation to allow for changes to address local country needs. All brochures, once translated, were returned to the lead country (Belgium) and printed to produce the final versions. Investigators confirmed all patients from group B had received and read the EMs at study follow-up by asking the question 'Have you read the educational material?' All patients included in the analysis provided informed consent. Patients were followed up at 1 year (±8 weeks) and 2 years (±8 weeks) in accordance with standard clinical care, and as deemed appropriate according to local country practice. The study was performed in accordance with the Declaration of Helsinki and approved by the relevant ethical committees.
End Points
The primary objective was to assess and compare the 1-year compliance rate across the two observational arms, based on patient assessment. The secondary objectives were to assess and compare across the two observational arms: compliance at 1 year (investigator assessment) and 2 years (investigator and patient assessments); persistence at 1 and 2 years (investigator assessment); time to discontinuation of adjuvant AI medication; and reasons for adjuvant AI treatment discontinuation.
Patients were considered to be compliant to adjuvant AI if they did not switch from any AI to tamoxifen. If a patient switched from the initial AI to another AI or hormone therapy, they were deemed to be noncompliant. A sensitivity analysis was performed to determine patient compliance with initial AI; patients who did not switch from the initial AI to another AI or any other hormone therapy were considered compliant to initial AI. Patients were classified as persistent users if they did not switch AI medication and AI medication was not discontinued.
Exploratory End Points
Exploratory end points (assessed at 1 year and 2 years) included assessment of the impact of parameters that may have an influence on adjuvant AI treatment compliance and persistence (including demographic and other baseline characteristics, employment status, education, early-stage breast cancer history and therapies), and patient- and investigator-reported outcome variables: the Functional Assessment of Breast Cancer Therapy – Endocrine Symptoms subscale (FACT-ES) in countries where validated translations of the questionnaire exist; the 12-item General Health Questionnaire (GHQ-12); and the European Organization for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire (EORTC IN-PATSAT-32) for patients and investigators. In these quality-of-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.
Data Collection
The primary outcome assessment of compliance was modeled on that used in the previous PACT Program. At study start, and at 1- and 2-year follow-up, patients completed a questionnaire assessing compliance during the clinic visit. The primary outcome variable was self-assessed using the following question:
'You were prescribed to take your hormone medication each day. However, it could be possible that sometimes you didn't take your medication, therefore how many tablets could you say that you actually did take during the last year?'
Answers were graded as: 0–5 (Table 1). Patients were defined as compliant if they scored 5 or 6 (≥80%); scores between 0 and 4 led to a noncompliant classification. Physician-reported compliance was based on the number of prescriptions written in the previous year.
Persistence was evaluated at 1 and 2 years by the following question asked by the investigator:
'Are you still taking the upfront hormone medication you were prescribed before you entered this study?'
Patients were defined as persistent if they answered 'Yes' and investigator-documented case report form (CRF) data supported persistent intake of adjuvant AI medication since last study visit. Discontinuation was assessed over the 2 years follow-up. Time to treatment discontinuation was defined as number of days between date of first and last intake of AI medication. If a patient discontinued study treatment during the first year and the second year, only the last discontinuation was taken into account. All discontinuations and the reasons were recorded. The number of patients switching treatment was recorded, but no additional information such as reasons for switch was collected.
