mHealth Coping Skills Training for Symptom Management (mCOPE) for colorectal cancer patients in early to mid-adulthood: Study protocol for a randomized controlled trial.
Contemp Clin Trials Commun
; 33: 101126, 2023 Jun.
Article
em En
| MEDLINE
| ID: mdl-37077935
ABSTRACT
Background:
Colorectal cancer (CRC) patients in early to mid-adulthood (≤50 years) are challenged by high symptom burden (i.e., pain, fatigue, distress) and age-related stressors (e.g., managing family, work). Cognitive behavioral theory (CBT)-based coping skills training interventions reduce symptoms and improve quality of life in cancer patients. However, traditional CBT-based interventions are not accessible to these patients (e.g., in-person sessions, during work day), nor designed to address symptoms within the context of this stage of life. We developed a mobile health (mHealth) coping skills training program for pain, fatigue and distress (mCOPE) for CRC patients in early to mid-adulthood. We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality of life and symptom self-efficacy (secondary outcomes). Methods/Design:
Patients (N = 160) ≤50 years with CRC endorsing pain, fatigue and/or distress are randomized 11 to mCOPE or standard care. mCOPE is a five-session CBT-based coping skills training program (e.g., relaxation, activity pacing, cognitive restructuring) that was adapted for CRC patients in early to mid-adulthood. mCOPE utilizes mHealth technology (e.g., videoconference, mobile app) to deliver coping skills training, capture symptom and skills use data, and provide personalized support and feedback. Self-report assessments are completed at baseline, post-treatment (5-8 weeks post-baseline; primary endpoint), and 3- and 6-months later.Conclusions:
mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate initial efficacy of a mHealth cognitive behavioral intervention to reduce symptom burden in younger CRC patients.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Aspecto:
Patient_preference
Idioma:
En
Revista:
Contemp Clin Trials Commun
Ano de publicação:
2023
Tipo de documento:
Article