Clinical trial · Interventional
A Digital Solution for Breast Cancer Patients
Sidekick Health Digital Health Program (SK-421) for Breast Cancer Patients: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A digital health program for patients with Breast Cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital intervention group
- description
- Participants will be instructed to download the Sidekick Health app and receive a code to access the 14-week digital intervention in addition to standard of care, as is defined for the control arm. Beyond this, all patients in the interventional arm will also receive standard of care as defined for the control arm.
- interventionNames
- Device: A digital health program for patients with Breast Cancer
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- The control arm will receive standard of care treatment. Standard of care includes medical treatment at Landspitali University Hospital, and optional cancer rehabilitation at the Ljósið Cancer Rehabilitation Center.
Primary outcomes (1)
- measure
- Cancer-specific Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female adults diagnosed with breast cancer stage 1, 2, 3 or 4 * Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy. * Fluent in verbal and written Icelandic or English * Capacity to give informed consent * Capacity to operate a smartphone Exclusion Criteria: * Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device * Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist * Pregnancy
References
Publications (0)
Data not yet available