About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Sequential
Treatments tested in this trial
Discussion
Procedure/SurgeryParticipate in think-aloud sessions
Educational Activity
Other interventionReceive health coaching
Internet-Based Intervention
Other interventionUse Healthy Buckeyes app
Internet-Based Intervention
Other interventionWatch videos
Interview
Other interventionComplete semi-structured interview
Medical Device Usage and Evaluation
Other interventionWear Fitbiit and use exercise bands
Questionnaire Administration
Other interventionAncillary studies
Supportive Care
Other interventionReceive caregiver support
Survey Administration
Other interventionComplete surveys
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.