Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Noom Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Qualitative interviews
研究概览
简要总结
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
详细描述
This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Participants will be recruited and asked to try the HCC app for 4 weeks. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app, the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to understand and provide informed consent
- •18 years and older
- •> 6 months postpartum
- •Not currently pregnant or planning to become pregnant in the next 5 months
- •Diagnosed with stage I-IV breast cancer < 5 years ago:
- •Completed active breast cancer treatment (e.g., chemotherapy, radiation, surgery) 1 month to 5 years ago, with the exception of hormonal/endocrine therapy
- •Currently prescribed hormone therapy (e.g. Tamoxifen) as a breast cancer treatment
- •Not diagnosed with an eating disorder
- •Healthy weight, overweight, or obesity (BMI ≥ 18.5)
- •Willingness to use the program over the course of the 4 weeks in order to enable them to provide feedback on its features
- •Own a smartphone with iOS operating system (i.e., Apple iPhone)
排除标准
- •Inability or unwillingness of a participant to give written informed consent
- •Underweight (BMI < 18.5)
- •Currently pregnant or <6 months postpartum
- •Presence of a diagnosed physical or mental health condition or abnormality that impacts the ability to participate in a program that involves asking participants to monitor diet, physical activity, or weight (e.g., eating disorder, bipolar disorder). If there is any doubt at initial screening the investigator will recommend that the patient receives sign off from their clinical team.
- •Currently undergoing IV chemotherapy or radiation
- •Plans for surgery in the next 6 weeks
- •Currently diagnosed or being treated for a second primary cancer (i.e. cancer of another organ, not due to breast cancer metastasis), with the exception of non-melanoma skin cancers (e.g. basal cell carcinoma)
结局指标
主要结局
Qualitative interviews
时间窗: 4 weeks
Data analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.
Functional Assessment of Cancer Therapy - Breast quality-of-life instrument
时间窗: 4 weeks
Self reported measure of multidimensional quality of life (QL) in patients with breast cancer.
次要结局
未报告次要终点