Feasibility, Acceptability, and Preliminary Outcomes of a Mobile App for Coping With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Participant interest
研究概览
简要总结
The goal of this clinical trial is to learn if a mobile app program for people with a history of cancer can help treat distress. The main questions it aims to answer is:
Do participants use the Tools for Coping with Cancer Calm Health mobile app and do they find it helpful?
Does the Tools for Coping with Cancer Calm Health mobile app improve mood, quality of life, and help with coping?
Participants will be asked to use a 13-session self-management program (Tools for Coping with Cancer) housed within the Calm Health app. Participants will use this app on their own device, in their own home. Participants will have access to the program for 8 weeks and will be asked to work their way through the program at their own pace. Participants will be asked to complete questionnaires about their mood, quality of life, coping, and experience with the app three times: at the start of the study, after 8 weeks using the app, and then 3-months after using the app.
详细描述
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effectiveness of a self-management mobile app on mood, quality of life, psychological flexibility, and adaptive coping in a population of people with cancer.
The intention of this research is to meet the most common unmet supportive care needs such as anxiety and depression, pain, insomnia, and fear of cancer recurrence utilizing evidence-based intervention that is accessible and self-paced.
We hypothesize that the Tools for Coping with Cancer mobile app program will:
- Be feasible and acceptable to participants, as rated by interest, accrual, and completion rates, acceptability ratings, and participant satisfaction with the program.
- Have a statistically significant effect on symptoms of depression, anxiety, psychological flexibility, adaptive coping, and quality of life. We further hypothesize that these improvements will be retained at 3-months post-intervention.
The primary objective is to determine the feasibility and acceptability of a self-management mobile app intervention as measured by participant interest, accrual, completion, satisfaction, acceptability, and app usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stated willingness to comply with all study procedures and availability for the duration of the study (8 weeks active intervention and 3-month follow up)
- •Have a confirmed diagnosis of cancer; or have been treated for cancer within the last two years, including adjuvant therapies
- •Over the age of 18
- •Able to understand and read English
- •Able to navigate a mobile app with minimal assistance from study staff
- •Able to provide informed consent
排除标准
- •Are taking part in psychotherapy at any time during the study
- •Have an un-treated or under-treated mental health disorder based on pre-study screening that may require a referral to individual mental health care.
研究组 & 干预措施
Mobile App Intervention
Participants will be asked to use the 13-session Coping with Cancer Program in a mobile app.
干预措施: Tools for Coping with Cancer Calm Health mobile app program (Device)
结局指标
主要结局
Participant interest
时间窗: Up to 12 months
The number of individuals who initiate evaluating eligibility.
Accrual
时间窗: Up to 12 months
The number of individuals who provide consent.
Participant completion
时间窗: Up to 12 months
The number of individuals who complete all sessions of the program.
Participant satisfaction
时间窗: Up to 18 months
A Likert-type scale ranging from very dissatisfied to very satisfied on the program overall as well as each session. Minimum value: 0 (not at all satisfied) Maximum value: 140 (Very satisfied with the program as a whole; very satisfied with each individual session) Lower numbers indicate worse outcome.
Helpfulness
时间窗: Up to 18 months
A Likert-type scale ranging from very unhelpful to very unhelpful on the program overall as well as each session. Minimum value: 0 (not at all helpful) Maximum value: 140 (Found program as a whole and each individual session very helpful). Lower numbers indicate worse outcome.
Acceptability
时间窗: Up to 18 months
A 10-item acceptability questionnaire (Theoretical Framework of Acceptability) evaluating affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability. Minimum value: 0 Maximum value: 100 Higher score indicates greater acceptability
Usage
时间窗: Up to 18 months
Participant usage of the app, including frequency and duration of session play will be captured.
次要结局
- Depression(Up to 18 months)
- Anxiety(Up to 18 months)
- Adaptive Coping(Up to 18 months)
- Health Related Quality of Life(Up to 18 months)
- Psychological Flexibility(Up to 18 months)