Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 10 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study develops and tests a mobile health program for people who have survived colon or rectal cancer and their family caregivers. It aims to help them follow recommended eating and physical activity habits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients must be 18 or older and have had stage I–III colon or rectal cancer.
- Patients must have had surgery to fully remove the cancer with the goal of a cure. Some people treated for rectal cancer without surgery may qualify.
- Patients must have finished cancer treatment at least 6 months ago.
- Patients and caregivers must have a smartphone with internet and text messaging, speak and read English, and be able to understand and agree to join.
- Patients must be able to exercise on their own, based on a safety questionnaire, and get a doctor's approval if needed. They must have an ECOG score of 0–2, a rating of how well they can do daily activities.
- Patients must have a caregiver willing to support them and join the study.
- Caregivers must be 18 or older, live with the patient, and take part in all required program activities and assessments, including those for a wait-list group if needed.
- Cancer care professionals, nurses, dietitians, exercise specialists, physical therapists, patient navigators, advocates, and social workers may join as experts if they have at least 12 months of experience working with colon or rectal cancer survivors.
Who can't join
- These rules apply to both patients and caregivers: exercise safety concerns found by the questionnaire without a doctor's approval to exercise.
- Planned major surgery or any scheduled cancer treatment during the study.
- Another cancer being actively treated, except non-melanoma skin cancer, early cervical cancer that has not spread, or prostate cancer limited to the prostate and only being watched.
- Severe heart, lung, muscle, bone, or joint problems that prevent moderate exercise.
- Mental health conditions that prevent taking part or understanding and agreeing to join.
- Taking part in another clinical trial for weight loss, physical activity, or diet.
- Pregnant now or trying to become pregnant during the study.
- Living outside the United States during the study or currently being a prisoner.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Roberto M. Benzo, PhD · Study contact · 614-293-3675 · Roberto.Benzo@osumc.eduRoberto M. Benzo, PhD · Principal investigatorMore trials in Columbus