Stage I Colon Cancer AJCC v8NCT06746012
Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
A study testing Discussion, Educational Activity and Internet-Based Intervention in people with Stage I Colon Cancer AJCC v8 and Stage I Rectal Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8
- What is being tested?
- Discussion, Educational Activity and Internet-Based Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Macy Tetrick contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Roberto M. Benzo, PhD, 614-293-3675, Roberto.Benzo@osumc.edu
Roberto M. Benzo, PhD
About this study
Official title: Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Being tested
- Discussion, Educational Activity, Internet-Based Intervention, Interview, Medical Device Usage and Evaluation
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionProcedure or surgery
Also called Discuss
Participate in think-aloud sessions
Educational ActivityOther
Receive health coaching
Internet-Based InterventionOther
Use Healthy Buckeyes app
Internet-Based InterventionOther
Watch videos
InterviewOther
Complete semi-structured interview
Medical Device Usage and EvaluationOther
Wear Fitbiit and use exercise bands
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive caregiver support
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Survey Administration |
| 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. Receives: Procedure: Discussion; Other: Interview; Other: Survey Administration |
| 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. Receives: Other: Educational Activity; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Supportive Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Colon Cancer AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Benzo, Ohio State University Comprehensive Cancer Center
- Investigators
- Roberto M Benzo, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746012
- Sponsor's protocol ID
- OSU-23222
- Other IDs
- NCI-2024-01073
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study
- ClinicalTrials.gov ID
- NCT06746012
- Acronym / sponsor ID
- OSU-23222
- Conditions
- Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I (design) | Active comparator | Other: Survey AdministrationSurvivor-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 |
| Phase II (user-experience testing) | Active comparator | Procedure: Discussion, Other: Interview, Other: Survey AdministrationDyads 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. |
| Phase III (pilot study) | Experimental | Other: Educational Activity, Other: Internet-Based Intervention, Other: Interview, Other: Medical Device Usage and Evaluation, Other: Questionnaire Administration, Other: Supportive Care, Other: Survey AdministrationDyads 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussParticipate in think-aloud sessions | Procedure or surgery | Phase II (user-experience testing) |
| Educational ActivityReceive health coaching | Other | Phase III (pilot study) |
| Internet-Based InterventionUse Healthy Buckeyes app | Other | Phase III (pilot study) |
| Internet-Based InterventionWatch videos | Other | Phase III (pilot study) |
| InterviewComplete semi-structured interview | Other | Phase II (user-experience testing), Phase III (pilot study) |
| Medical Device Usage and EvaluationWear Fitbiit and use exercise bands | Other | Phase III (pilot study) |
| Questionnaire AdministrationAncillary studies | Other | Phase III (pilot study) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive caregiver support | Other | Phase III (pilot study) |
| Survey AdministrationComplete surveys | Other | Phase I (design), Phase II (user-experience testing), Phase III (pilot study) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Macy Tetrick contact
Roberto M Benzo, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Educational Activity and Internet-Based Intervention in people with Stage I Colon Cancer AJCC v8 and Stage I Rectal Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived usability (Phase II) (time frame: Up to 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.