Technology-Supported Behavioral Activation to Optimize Day-to-Day Quality of Life With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this study is to learn if behavioral activation can improve daily quality of life for patients with advanced cancer. The main questions it aims to answer are:
- Can behavioral activation be adapted to help patients living with advanced cancer optimize their daily quality of life?
- Can behavioral activation be delivered primarily via smartphone?
Participants will:
- Complete a demographic questionnaire at the beginning of the study and quality-of-life and activity questionnaires at the beginning, midpoint, and end of study. Complete nightly surveys about daily quality of life, mood, activities, and experiences.
- Wear a Fitbit activity tracker for 8 weeks.
- After the first four weeks, they will complete a session with a member of our team about their day-to-day activities, behaviors, and experiences. They will select at least 4 activities/behaviors to increase over the next portion of the study.
- Incorporate personalized meaningful activities into daily life
- At the end of approximately eight weeks, (four weeks after the session with a study team member), they will complete a semi-structured interview.
详细描述
Participants (n=25) will be recruited from UPMC Hillman clinics.
Part 1 (Consent and Baseline data collection from weeks 1 to 4):
If eligible patients consent to participate, they will complete online baseline questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will be linked only to their study ID number.
At the initial visit (either in-person or online, 20-30 minutes), participants will also be oriented to the ecological momentary assessment procedures to assess self-reported daily quality of life and mood, activities, and experiences. Participants will install the BALANCE Android or iOS application on their smartphones. The participant ID will be entered into the app upon initial log in and will be saved locally on the device. Participants will have the opportunity to add additional activities to track for 2 days before the 4 weeks of Part 1 of the study begins. When participants receive the survey notification, it will open the application and they can proceed to take the survey in the BALANCE app on their smartphone. Participants will be asked to complete the EMA questions once each evening (approximately 5 minutes). Participants will be able to use the BALANCE app to access visualizations of their past survey responses and quality of life ratings along with activity and sleep data.
Participants will also be asked to wear a Fitbit device (Fitbit Inspire 3 or similar) for the duration of the study and to install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. If they already own a Fitbit device, we will request access to their Fitbit data for the duration of their study participation.
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
- •diagnosed with Stage IV cancer and receiving ongoing treatment at a UPMC Hillman Cancer Center clinic
- •owns and uses a smartphone capable of running study applications
排除标准
- •Unable to read, write, or communicate in English
研究组 & 干预措施
Activity tracking via smartphone app
Participants will rate their day and indicate activities they did that day via the smartphone once each evening for the first four weeks. After four weeks, they will complete a mid-study data review session with a study team member about the activities, behaviors, and experiences they believe are most strongly related to their day-to-day quality of life. For the last 4 weeks of the study, they will select at least 4 behaviors or activities to increase. Participants will fill out morning surveys to plan an activity, receive daily reminders through the BALANCE app to support behavior change, and complete evening surveys to report daily quality of life and indicate completed activities.
干预措施: Behavioral Activation (Behavioral)
结局指标
主要结局
Feasibility
时间窗: From enrollment to the end of intervention at approximately 8 weeks
accrual rate (number of participants that enroll out of number of participants approached)
Acceptability
时间窗: At the end of intervention at approximately 8 weeks
System Usability Scale (SUS). For odd items, subtract one from the user response. For even-numbered items, subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. Possible range of scores is 0 to 100 representing a composite measure of the overall usability of the system being studied.
Acceptability
时间窗: At end of intervention at approximately 8 weeks
Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the program
次要结局
- Daily ratings(Change from baseline to the end of intervention at approximately 8 weeks)
- Quality of Life(Change from baseline to the end of intervention at approximately 8 weeks)
- Depressive symptoms(Change from baseline to the end of intervention at approximately 8 weeks)
研究者
Carissa Low
Associate Professor
University of Pittsburgh