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New treatment option for Stage I Colon Cancer AJCC v8
Official title Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
ClinicalTrials.gov ID: NCT06746012
What this study is testing
- What it's testing
- 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).
- Time commitment: about 10 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Self-reported history of severe cardiovascular, respiratory, musculoskeletal disease, or joints problems that preclude moderate physical activity (PA)
See the full eligibility 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.