Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Discussion

    Procedure/Surgery

    Participate in think-aloud sessions

  • Educational Activity

    Other intervention

    Receive health coaching

  • Internet-Based Intervention

    Other intervention

    Use Healthy Buckeyes app

  • Internet-Based Intervention

    Other intervention

    Watch videos

  • Interview

    Other intervention

    Complete semi-structured interview

  • Medical Device Usage and Evaluation

    Other intervention

    Wear Fitbiit and use exercise bands

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Supportive Care

    Other intervention

    Receive caregiver support

  • Survey Administration

    Other intervention

    Complete surveys

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: Phase I (design)Active comparator 1 intervention
Group B: Phase II (user-experience testing)Active comparator 3 interventions
Group C: Phase III (pilot study)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year
2

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.

Time frame
Up to 1 year
3

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.

Time frame
Up to 1 year
4

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.

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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