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

Официальное название

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

Обзор

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.

Подробное описание

PRIMARY OBJECTIVES:

I. 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.

Вмешательства

• Процедура Discussion
  Participate in think-aloud sessions
• Другое Educational Activity
  Receive health coaching
• Другое Internet-Based Intervention
  Use Healthy Buckeyes app
• Другое Internet-Based Intervention
  Watch videos
• Другое Interview
  Complete semi-structured interview
• Другое Medical Device Usage and Evaluation
  Wear Fitbiit and use exercise bands
• Другое Questionnaire Administration
  Ancillary studies
• Другое Supportive Care
  Receive caregiver support
• Другое Survey Administration
  Complete surveys

Первичные конечные точки

• Perceived usability (Phase II) [Срок оценки: Up to 1 year]
• End user's perception of the quality of the mHealth application (Phase II) [Срок оценки: Up to 1 year]
• User acceptance of mHealth services (Phase II) [Срок оценки: Up to 1 year]
• Usability (Phase III) [Срок оценки: Up to 1 year]
• Acceptability of the program (Phase III) [Срок оценки: Up to 1 year]
• End user's perception of the quality of the mHealth application (Phase III) [Срок оценки: Up to 1 year]
• Recruitment rate (Phase III) [Срок оценки: Up to 1 year]
• Adherence rate (Phase III) [Срок оценки: Up to 1 year]
• Retention rate (Phase III) [Срок оценки: Up to 1 year]
• Acceptability of the measurement rate (Phase III) [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT06746012 · OSU-23222 · NCI-2024-01073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗