Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Perceived usability (Phase II)
研究概览
简要总结
This clinical trial develops and tests a mobile health (mHealth) intervention to improve adherence to lifestyle recommendations in colorectal cancer (CRC) survivors and their family caregivers. The current challenge for cancer survivorship is identifying novel approaches to help adhere to the lifestyle recommendations that have been shown to improve symptom burden, health outcomes, and health-related quality of life (HRQoL). The development of a digital health intervention specifically for CRC survivors and family caregivers may improve adherence to the American Cancer Society Nutrition and Physical Activity Guideline for Cancer Survivors and improve family health.
详细描述
PRIMARY OBJECTIVES:
I. Conduct a 12-week, single-arm pilot study to test the digital lifestyle intervention's acceptability, feasibility, and intended effects in 10 CRC survivors-caregiver dyads.
OUTLINE:
PHASE III (PILOT STUDY): Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- 是
入选标准
- •PATIENTS INCLUSION:
- •Adults (18 years of age or older)
- •Diagnosis of stage I-III colon or rectal cancer
- •Undergone curative-intent complete surgical resection (patients who have received non-operative management for rectal cancer may be eligible)
- •Completed treatment (i.e., neo-adjuvant, adjuvant cytotoxic chemotherapy, radiation, or surgical resection) at least six months prior
- •Own a smartphone with internet access and can receive text messages
- •Able to speak, read, and understand English
- •Self-report ability to independently engage in physical activity determined by the Physical Activity Readiness questionnaire (PAR-Q), and if indicated obtain physician clearance
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 determined via medical chart review
- •Presence of a family caregiver (i.e., informal or formal caregiver) willing support the patient and participate in the study
- •Able to provide informed consent
- •FAMILY CAREGIVER INCLUSION:
- •Any adult that resides in the same household as the patient
- •Willing to participate in all aspects of the intervention and in the assessments required for those in the wait-list control condition if applicable
- •Meets the patient inclusion criteria number 1, 5, 6, and 10
- •SMES INCLUSION:
- •Medical, radiation, and surgical oncologists; advanced practice providers, registered nurses; dietitians; exercise physiologists; physical therapists, patient navigators and champions/advocates, and social workers with at least 12 months of experience working with CRC survivors
排除标准
- •PATIENTS EXCLUSION:
- •People with potential contraindications to exercise based on the PAR-Q, for those we are unable to obtain physician clearance
- •Planned major surgery during the study period
- •Scheduled to receive any form of cancer therapy during study participation
- •Concurrent, actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)
- •Self-reported history of severe cardiovascular, respiratory, musculoskeletal disease, or joints problems that preclude moderate physical activity (PA)
- •Self-reported history of psychiatric disorders that preclude participation in the study intervention or prevent the patient from giving informed consent
- •Concurrent participation in another weight loss, PA, or dietary intervention clinical trial
- •Currently pregnant or trying to become pregnant during the study period
- •living outside the United States (US) during the study period
- •Currently a prisoner
- •FAMILY CAREGIVER EXCLUSION:
- •The same as the patient exclusion criteria
研究组 & 干预措施
Phase I (design)
Survivor-caregiver dyads and SMEs complete semi-structured interview over 60-90 minutes and surveys over 15 minutes for intervention content, format, and feature design and development on study
干预措施: Survey Administration (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Questionnaire Administration (Other)
Phase II (user-experience testing)
Dyads complete semi-structured interview and participate in think-aloud sessions over 60-90 minutes and complete surveys over 15 minutes to test the Healthy Buckeyes app on study.
干预措施: Discussion (Procedure)
Phase II (user-experience testing)
Dyads complete semi-structured interview and participate in think-aloud sessions over 60-90 minutes and complete surveys over 15 minutes to test the Healthy Buckeyes app on study.
干预措施: Interview (Other)
Phase II (user-experience testing)
Dyads complete semi-structured interview and participate in think-aloud sessions over 60-90 minutes and complete surveys over 15 minutes to test the Healthy Buckeyes app on study.
干预措施: Survey Administration (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Educational Activity (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Internet-Based Intervention (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Interview (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Medical Device Usage and Evaluation (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Supportive Care (Other)
Phase III (pilot study)
Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Perceived usability (Phase II)
时间窗: Up to 1 year
Will be evaluated via the System Usability Scale (SUS), a ten-item questionnaire rated on a 5-point Likert scale, with a high level of reliability with a coefficient alpha of 0.91.
End user's perception of the quality of the mHealth application (Phase II)
时间窗: Up to 1 year
Will be assessed using the User Mobile Application Rating Scale (uMARS), which includes 20 items rated on a 5-point scale and a total of six sections, including engagement, functionality, aesthetics, information quality, subjective quality, and perceived impact.
User acceptance of mHealth services (Phase II)
时间窗: Up to 1 year
Will be assessed using the Technology Acceptance Model (TAM), which displays how users use and accept technology. The TAM includes 12 items divided into perceived usefulness and perceived ease of use.
Usability (Phase III)
时间窗: Up to 1 year
Will be assessed using the SUS, a 10-item scale, with a score ranging from 0 to 100; where a score of \> 68 is considered above average.
Acceptability of the program (Phase III)
时间窗: Up to 1 year
Will be determined using the Net Promoter Score (NPS), a single-item 11-point scale asking, "How likely is it that you would recommend to a friend or colleague?" using the NPS survey (Reichheld, 2003). Will deem the program acceptable if the average score is \>= 7.
End user's perception of the quality of the mHealth application (Phase III)
时间窗: Up to 1 year
Will be assessed using the uMARS (Stoyanov, Hides, Kavanagh, \& Wilson, 2016b), which includes 20 items rated on a 5-point scale and a total of six sections, including engagement, functionality, aesthetics, information quality, subjective quality, and perceived impact.
Recruitment rate (Phase III)
时间窗: Up to 1 year
Will be defined as the percentage of screened and eligible participants who enroll, and determined 50% as an acceptable threshold.
Adherence rate (Phase III)
时间窗: Up to 1 year
Will be defined as the number of participants who used the digital devices as indicated, and determined 70% as an acceptable threshold.
Retention rate (Phase III)
时间窗: Up to 1 year
Will be defined as the percentage of enrolled participants who complete the program, and determined 70% as an acceptable threshold.
Acceptability of the measurement rate (Phase III)
时间窗: Up to 1 year
Will be defined as the number of participants who complete both the baseline and post-assessment measures.
次要结局
未报告次要终点
研究者
Roberto Benzo
Principal Investigator
Ohio State University Comprehensive Cancer Center