Breast Cancer, Cancer
Conditions
Keywords
Cancer, Breast Cancer, Medication adherence, self-efficacy, lifestyle change, endocrine treatment, digital health application
Brief summary
This is a randomized, controlled study to assess the effect of Sidekick Health's digital program on self-efficacy and medication adherence in breast cancer patients prescribed adjuvant anti-hormonal treatment. Participants will be treated with the digital program in addition to standard of care (SoC), or SoC only.
Detailed description
Sidekick Health has developed a digital patient support tool delivered via mobile application (app), to support people who have been diagnosed with breast cancer with self-efficacy in managing their symptoms and with medication adherence and holistic lifestyle modification. The Sidekick platform includes a medication center, including behavioral change material and tools aimed at improving adherence. The study will be a 2-arm, parallel-group, randomized (1:1) controlled trial to evaluate the performance of Sidekick's digital patient support program for patients with breast cancer on patients' self-efficacy and medication adherence in women undergoing adjuvant endocrine treatment. 140 participants will be included, and eligible participants will be randomized to receive the Sidekick digital support program plus standard of care, or standard of care only.
Interventions
DEVICESidekick digital patient support program for patients with breast cancer
A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.
OTHERStandard of care for breast cancer patients
Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation
Sponsors
Landspitali University Hospital
University of Iceland
Icelandic Research Center
Sidekick Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded for group assignment at the primary analysis (at 12 weeks).
Intervention model description
Single-center, prospective, open-label, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (18 years or older) diagnosed with breast cancer of stage I, II or III from 1st September 2023 or later * Have been prescribed adjuvant endocrine therapy for breast cancer. * Understands written and spoken Icelandic or English. * Owns a smart-phone compatible with the Sidekick app and capable to use it * Willing to download the Sidekick app on the smart-phone and to comply with the study measures and visits according to the protocol. * Capable of providing informed consent for participating in the study.
Exclusion criteria
* Having other concurrent conditions that in the opinion of the oncologist may compromise patient safety or study objectives. * Concurrent participation in another clinical study in which the study treatment may confound the evaluation of the investigational program. * Metastatic breast cancer (stage IV) * Previous experience with Sidekick breast cancer program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy and health education impact | 12 weeks from baseline | Difference in change in total score of the Health Education Impact Questionnaire (heiQ) between the intervention and control groups. The heiQ has 8 subscales and is composed of in total 42 questions with a Likert scale of 4 options where 1 represents strongly disagree to 4 strongly agree. Scores on the heiQ range from 42 to 168, with a lower score representing a low impact on patient education. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy and health-education impact after 24 weeks and 1 year | 24 weeks and 1 year | Group differences in self-efficacy measured by eight scales of Health Education Impact Questionnaire (heiQ) at 24 weeks and 1 year. |
| Medication adherence after 24 weeks and 1 year according to MARS-5 | 24 weeks and 1 year | Group difference in self-reported adherence according to MARS-5 questionnaire after 24 weeks and 1 year. |
| Adherence (PDC) to adjuvant endocrine treatment over 1 year | 1 year | Adherence to adjuvant endocrine breast cancer treatment over 1 year based on percentage of days covered (PDC) from data from the Icelandic Medicine Registry. The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest, in this case 1 year. |
| Medication persistence | 1, 2, 3 and 5 years | Compare the difference between groups in the proportion of participants still taking antihormonal therapy after 1, 2, 3 and 5 years, based on data from the Icelandic Medicine Registry. |
| BMI | 12, 24 weeks and 1 year | Group difference in Body Mass Index (BMI) calculated from self-reported weight and height at 12, 24 weeks and 1 year. BMI = weight (kg) ÷ height2 (meters) |
| Medication adherence according to MARS-5 questionnaire | 12 weeks from baseline | Group difference in self-reported adherence according to MARS-5 questionnaire at 12 weeks The MARS-5 questionnaire consists of five questions measuring adherence ranging from never (5 points) to always (1 points), therefore the score has a range from 5 - 25 points with higher score indicating high medication adherence. |
| Endocrine treatment symptom management | 12, 24 weeks and 1 year | Group difference in total score of Endocrine Therapy Symptoms from Endocrine Symptoms Questionnaire at 12, 24 weeks and 1 year The questionnaire is composed of 11 questions, where 10 are answered on a Likert scale of 4 options where 1 represents not at all to 4 very much, and 1 question with a 2-option yes or no. |
| Work status questionnaire | 12, 24 weeks and 1 year | Work status is a categorical variable representing participants' self-reported employment condition at each follow-up time point. This outcome will be used to assess potential group differences over time. No validation measurement tool is used, only questions regarding participant status. Work full time Work part-time 50-99% Work part-time, \<50% Not on the labor market And reason for not being on labor market or working part time Sick leave Disability Pension Unemployed Other |
| In app PRO on sleep, energy, stress, quality of life | 12 and 24 weeks | One PRO that asks users to rate the quality of sleep, energy level, stress level and quality of life. The longitudinal change of in-app ePRO in the intervention group will be analysed for these parameters: * quality of sleep * energy levels * stress levels * quality-of-life thermometer |
| User satisfaction in intervention group by MAUQ | 12 weeks | Scores in the mHealth App Usability Questionnaire (MAUQ) of the intervention group. The MAUQ is an 18-item questionnaire. It is composed of questions with Likert scales of 7 options where 1 represents strongly disagree to 7 strongly agree. Scores on the MAUQ range from 18 to 126, with a higher score representing a higher usability. |
| Engagement, retention and overall activity in the digital intervention | 12 and 24 weeks | Percentage of users that are active in the digital program, finish the program and engage with the content of the Sidekick digital Program |
| Physical activity from IPAQ-SF | 12, 24 weeks and 1 year | Group difference in self-reported physical activity according to IPAQ-SF at 12, 24 weeks and 1 year. |
Countries
Iceland
Contacts
Primary ContactSigridur Lara Gudmundsdottir, PhD
Outcome results
None listed