NCT06746012 · Ohio State University Comprehensive Cancer Center
Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Discussion
Participate in think-aloud sessions
OTHER
Educational Activity
Receive health coaching
OTHER
Internet-Based Intervention
Use Healthy Buckeyes app
OTHER
Internet-Based Intervention
Watch videos
OTHER
Interview
Complete semi-structured interview
OTHER
Medical Device Usage and Evaluation
Wear Fitbiit and use exercise bands
OTHER
Questionnaire Administration
Ancillary studies
OTHER
Supportive Care
Receive caregiver support
OTHER
Survey Administration
Complete surveys
Primary outcome measures
Perceived usability (Phase II)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 1 year
Will be defined as the number of participants who complete both the baseline and post-assessment measures.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations