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NCT Number: NCT06989450

Digital Patient Support Program for Self-efficacy and Medication Adherence in Women on Adjuvant Endocrine Treatment for Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Landspitali University Hospital

Reykjavik, 101, Iceland

Location status: Recruiting

Location contact

Soley Dilja Stefansdottir, Nurse

CONTACT

[email protected]

+3546218594

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sidekick digital patient support program for patients with breast cancer

Device

A digital health program delivered through an app that provides holistic lifestyle intervention and medication adherence support.

Standard of care for breast cancer patients

Other

Standard of care includes adjuvant breast cancer treatment and optional cancer rehabilitation

Primary outcomes

  1. Self-efficacy and health education impact

    Time frame: 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 outcomes

  1. Medication adherence according to MARS-5 questionnaire

    Time frame: 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.

  2. Self-efficacy and health-education impact after 24 weeks and 1 year

    Time frame: 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.

  3. Medication adherence after 24 weeks and 1 year according to MARS-5

    Time frame: 24 weeks and 1 year

    Group difference in self-reported adherence according to MARS-5 questionnaire after 24 weeks and 1 year.

  4. Adherence (PDC) to adjuvant endocrine treatment over 1 year

    Time frame: 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.

  5. Medication persistence

    Time frame: 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.

  6. BMI

    Time frame: 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)

  7. Physical activity from IPAQ-SF

    Time frame: 12, 24 weeks and 1 year

    Group difference in self-reported physical activity according to IPAQ-SF at 12, 24 weeks and 1 year.

  8. Endocrine treatment symptom management

    Time frame: 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.

  9. Work status questionnaire

    Time frame: 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

  10. In app PRO on sleep, energy, stress, quality of life

    Time frame: 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
  11. User satisfaction in intervention group by MAUQ

    Time frame: 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.

  12. Engagement, retention and overall activity in the digital intervention

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sigridur Lara Gudmundsdottir, PhD

CONTACT

[email protected]

+3546114475

Sponsors and collaborators

Lead sponsor

Sidekick Health

Industry

Collaborators

  • Icelandic Research Center
  • Landspitali University Hospital
  • University of Iceland

Registry information

Official study title

Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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