An mHealth Symptom Management Intervention for Colorectal Cancer Patients
mHealth Coping Skills Training for Symptom Management (mCOPE)
Maladies du côlon+13
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 15 septembre 2021
Date à laquelle le premier participant a commencé l'étude.There is a high level of evidence that suggests cognitive and behavioral factors play an important role in colorectal cancer patients' abilities to cope with pain, fatigue and distress. Patients with multiple persistent symptoms may be particularly likely to have low confidence in their ability to control their symptoms (i.e., self-efficacy for symptom management). Cognitive behavioral coping skills protocols can enhance patients' abilities to cope with their symptoms in the context of age-related challenges; to date, these protocols have been tested in older patients and neither intervention content nor delivery modality meet the needs of younger patients. Intervention protocols aimed at young and middle-aged patients dealing with age-related stressors and high time demands must be adapted to meet the needs and challenges (e.g., coping skills practice strategies within the context of competing demands, communication with others about symptoms and limitations, relaxation for managing stoma-related pain, activity pacing to manage fatigue due to cancer and the demands of multiple life roles; cognitive restructuring negative thoughts surrounding managing time off work for treatment while maintaining health insurance and arranging childcare) of younger adults with cancer and delivered in a format (e.g., videoconferencing, adjunctive mobile app) that is acceptable and does not incur further demands. The investigators propose to use a randomized controlled trial (RCT) to test an innovative mHealth Coping Skills Training for Symptom Management (mCOPE) intervention designed to target pain, fatigue, psychological distress, and quality of life with unique content adapted for young and middle-aged colorectal cancer patients. mCOPE will be delivered with convenient mHealth modalities (videoconferencing, mobile app supported). Young and middle-aged adults with colorectal cancer that endorse multiple symptoms will be randomized to: 1) mCOPE or 2) standard care. mCOPE includes 5 videoconferencing sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing, cognitive restructuring) relevant to managing pain, fatigue and distress, and improving quality of life in the context of the unique challenges facing younger patients. mCOPE uses mHealth technology, including a mobile app, to capture daily symptom and coping skills use data and provide personalized support and feedback to patients. The central hypothesis is that mCOPE will result in decreased pain, fatigue and distress, and increased quality of life. Specific study aims are: Aim 1: Test the efficacy of mCOPE for improving symptoms and quality of life. Aim 2: Examine improved self-efficacy for symptom management as a mediator of symptom severity.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.167 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 50 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Duke Cancer Institute
Durham, United States