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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01073 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I (design) | Active Comparator | 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 |
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| Phase II (user-experience testing) | Active Comparator | 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. |
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| Phase III (pilot study) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Procedure | Participate in think-aloud sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Perceived usability (Phase II) | 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. | Up to 1 year |
| End user's perception of the quality of the mHealth application (Phase II) | 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. | Up to 1 year |
| User acceptance of mHealth services (Phase II) | 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. | Up to 1 year |
| Usability (Phase III) | 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. | Up to 1 year |
| Acceptability of the program (Phase III) | 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. | Up to 1 year |
| End user's perception of the quality of the mHealth application (Phase III) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu | |
| Macy Tetrick | Contact | Macy.tetrick@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roberto M Benzo, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Educational Activity | Other | Receive health coaching |
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| Internet-Based Intervention | Other | Use Healthy Buckeyes app |
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| Internet-Based Intervention | Other | Watch videos |
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| Interview | Other | Complete semi-structured interview |
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| Medical Device Usage and Evaluation | Other | Wear Fitbiit and use exercise bands |
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| Questionnaire Administration | Other | Ancillary studies |
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| Supportive Care | Other | Receive caregiver support |
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| Survey Administration | Other | Complete surveys |
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| Up to 1 year |
| Recruitment rate (Phase III) | Will be defined as the percentage of screened and eligible participants who enroll, and determined 50% as an acceptable threshold. | Up to 1 year |
| Adherence rate (Phase III) | Will be defined as the number of participants who used the digital devices as indicated, and determined 70% as an acceptable threshold. | Up to 1 year |
| Retention rate (Phase III) | Will be defined as the percentage of enrolled participants who complete the program, and determined 70% as an acceptable threshold. | Up to 1 year |
| Acceptability of the measurement rate (Phase III) | Will be defined as the number of participants who complete both the baseline and post-assessment measures. | Up to 1 year |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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