Digital Patient Support Program for Self-Efficacy and Medication Adherence Amongst Women on Adjuvant Endocrine Treatment for Breast Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Self-efficacy and health education impact
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded for group assignment at the primary analysis (at 12 weeks).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Digital intervention group
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.
干预措施: Sidekick digital patient support program for patients with breast cancer (Device)
Digital intervention group
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.
干预措施: Standard of care for breast cancer patients (Other)
Standard of care - control group
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.
干预措施: Standard of care for breast cancer patients (Other)
结局指标
主要结局
Self-efficacy and health education impact
时间窗: 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.
次要结局
- Medication persistence(1, 2, 3 and 5 years)
- BMI(12, 24 weeks and 1 year)
- Physical activity from IPAQ-SF(12, 24 weeks and 1 year)
- Endocrine treatment symptom management(12, 24 weeks and 1 year)
- Medication adherence after 24 weeks and 1 year according to MARS-5(24 weeks and 1 year)
- Medication adherence according to MARS-5 questionnaire(12 weeks from baseline)
- Self-efficacy and health-education impact after 24 weeks and 1 year(24 weeks and 1 year)
- Adherence (PDC) to adjuvant endocrine treatment over 1 year(1 year)
- Work status questionnaire(12, 24 weeks and 1 year)
- In app PRO on sleep, energy, stress, quality of life(12 and 24 weeks)
- User satisfaction in intervention group by MAUQ(12 weeks)
- Engagement, retention and overall activity in the digital intervention(12 and 24 weeks)