Trial Outcomes & Findings for THRIVE Breast Cancer App Study (NCT NCT03592771)
NCT ID: NCT03592771
Last Updated: 2023-09-05
Results Overview
Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2023-09-05
Participant Flow
Participants were recruited from West Cancer Centers in East Memphis and Midtown, Memphis, Tennessee, USA. Participant enrollment began November 15, 2018 and all follow-up assessments were completed by June 30, 2022.
Participant milestones
| Measure |
Usual Care
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
98
|
102
|
|
Overall Study
COMPLETED
|
97
|
84
|
85
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
17
|
Reasons for withdrawal
| Measure |
Usual Care
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
15
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
THRIVE Breast Cancer App Study
Baseline characteristics by cohort
| Measure |
Usual Care
n=104 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=98 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=102 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
293 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
104 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Income
<100% Federal Poverty Level (FPL)
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Income
100 to 200% FPL
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Income
201 to 400% FPL
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Income
>400% FPL
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Income
Missing
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Education
High school or less
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Education
More than high school
|
85 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
244 Participants
n=4 Participants
|
|
Marital Status
Married or living with partner
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Marital Status
Other
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: This analysis includes participants who completed the 12 month follow-up assessment.
Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).
Outcome measures
| Measure |
Usual Care
n=97 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=84 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=85 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Adjuvant Endocrine Therapy (AET) Medication Adherence
|
77 percentage of prescribed doses taken
Standard Deviation 26
|
73 percentage of prescribed doses taken
Standard Deviation 28
|
71 percentage of prescribed doses taken
Standard Deviation 30
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: This analysis includes participants completing the indicated study visit.
Relative changes in adverse symptom burden were assessed using the Endocrine Symptom Subscale of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. The FACT-ES is a 46-item questionnaire asking participants to report how much they have been impacted by a variety of symptoms on a 5-point scale where 0 = not at all and 4 = very much. The Endocrine Symptom Subscale consists of 19 items with total raw scores ranging from 0 to 76. Higher scores indicate greater impact from symptoms.
Outcome measures
| Measure |
Usual Care
n=104 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=98 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=102 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Baseline
|
62.95 score on a scale
Standard Deviation 9.89
|
63.01 score on a scale
Standard Deviation 9.62
|
63.47 score on a scale
Standard Deviation 9.23
|
|
19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Month 12
|
60.14 score on a scale
Standard Deviation 11.82
|
59.29 score on a scale
Standard Deviation 11.49
|
60.54 score on a scale
Standard Deviation 11.26
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: This analysis includes participants who completed the indicated study visit and had no missing responses in this survey. Some participants were administered the survey but skipped questions.
Quality of life was measured with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. A scoring algorithm is used to generate a total score for the PCS component that ranges from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Outcome measures
| Measure |
Usual Care
n=103 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=97 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=101 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score
Month 12
|
44.69 score on a scale
Standard Deviation 10.83
|
47.57 score on a scale
Standard Deviation 10.02
|
45.25 score on a scale
Standard Deviation 10.32
|
|
Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score
Baseline
|
44.30 score on a scale
Standard Deviation 10.14
|
44.87 score on a scale
Standard Deviation 9.79
|
43.99 score on a scale
Standard Deviation 9.65
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: This analysis includes participants who completed the indicated study visit and had no missing responses in this survey. Some participants were administered the survey but skipped questions.
Quality of life was measured with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for the MCS component that ranges from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Outcome measures
| Measure |
Usual Care
n=103 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=97 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=101 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score
Baseline
|
50.66 score on a scale
Standard Deviation 9.59
|
50.76 score on a scale
Standard Deviation 9.86
|
50.68 score on a scale
Standard Deviation 10.02
|
|
Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score
Month 12
|
51.77 score on a scale
Standard Deviation 8.38
|
49.98 score on a scale
Standard Deviation 10.48
|
51.95 score on a scale
Standard Deviation 9.64
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: This analysis includes participants who completed the indicated study visit and had no missing responses in this survey. Some participants were administered the survey but skipped questions.
Relative changes in adverse symptom burden were measured using the 4-item PROMIS Self-Efficacy for Managing Symptoms short form questionnaire. Participants indicate how confident they are that they can manage their symptoms on a 5-point scale where 1 = not confident at all and 5 = very confident. Total scores range from 4 to 20 and higher scores indicate greater self-efficacy for managing symptoms.
Outcome measures
| Measure |
Usual Care
n=102 Participants
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=98 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=102 Participants
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score
Baseline
|
17.28 score on a scale
Standard Deviation 2.89
|
16.69 score on a scale
Standard Deviation 3.82
|
16.88 score on a scale
Standard Deviation 3.12
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score
Month 12
|
17.39 score on a scale
Standard Deviation 2.73
|
16.46 score on a scale
Standard Deviation 3.93
|
16.78 score on a scale
Standard Deviation 3.29
|
Adverse Events
Usual Care
Serious events: 15 serious events
Other events: 2 other events
Deaths: 0 deaths
THRIVE App
Serious events: 9 serious events
Other events: 0 other events
Deaths: 1 deaths
THRIVE App+Feedback
Serious events: 6 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Usual Care
n=104 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=98 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=102 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
General disorders
Hospitalization
|
14.4%
15/104 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
9.2%
9/98 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
5.9%
6/102 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
Other adverse events
| Measure |
Usual Care
n=104 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used an electronic pill monitoring device with their adjuvant endocrine therapy (AET) medication and completed a survey at baseline and again after 12 months.
|
THRIVE App
n=98 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
THRIVE App+Feedback
n=102 participants at risk
Participants with early-stage, hormone receptor positive breast cancer used a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants received reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group also received weekly tailored feedback text messages or images during the 6-month intervention phase. Participants used an electronic pill monitoring device with their AET medication and completed a survey at baseline and again after 12 months.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression caused change in treatment
|
0.96%
1/104 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
0.00%
0/98 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
0.00%
0/102 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
|
Product Issues
Side effects from AET caused change in treatment
|
0.96%
1/104 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
0.00%
0/98 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
0.98%
1/102 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place