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

Sidekick Health

Status: Enrolling

Conditions: Breast Cancer; Cancer

Treatments: Other: Standard of care for breast cancer patients; Device: Sidekick digital patient support program for patients with breast cancer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06989450

BC-99-IS-002

VSN24-126 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Digital intervention group

Experimental group

Description:

Participants will be instructed to download Sidekick Health app and receive a code to access the digital intervention in addition to standard of care, as is defined for the control arm. The digital patient support program empowers self-efficacy as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. The Sidekick platform includes a medication center, which constitutes of behavioral change educational material and methods aimed at improving adherence. Beyond this, all participants in the interventional arm will also receive standard of care as defined for the control arm.

Treatment:

Other: Standard of care for breast cancer patients

Device: Sidekick digital patient support program for patients with breast cancer

Standard of care - control group

Active Comparator group

Description:

The participants in the control arm will receive standard-of-care treatment. Standard of care includes adjuvant breast cancer treatment and any optional cancer rehabilitation that is not delivered through a mobile application.

Treatment:

Other: Standard of care for breast cancer patients