The eCALM Trial-eTherapy for cancer appLying mindfulness: online mindfulness-based cancer recovery program for underserved individuals living with cancer in Alberta: protocol development for a randomized wait-list controlled clinical trial

eCALM试验——应用正念的癌症电子疗法:面向阿尔伯塔省弱势癌症患者的在线正念癌症康复项目:一项随机等待名单对照临床试验的方案制定

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Abstract

BACKGROUND: Elevated stress can exacerbate cancer symptom severity, and after completion of primary cancer treatments, many individuals continue to have significant distress. Mindfulness-Based Cancer Recovery (MBCR) is an 8-week group psychosocial intervention consisting of training in mindfulness meditation and yoga designed to mitigate stress, pain, and chronic illness. Efficacy research shows face-to-face (F2F) MBCR programs have positive benefits for cancer patients; however barriers exist that impede participation in F2F groups. While online MBCR groups are available to the public, none have been evaluated. PRIMARY OBJECTIVE: determine whether underserved patients are willing to participate in and complete an online MBCR program. SECONDARY OBJECTIVES: determine whether online MBCR will mirror previous efficacy findings from F2F MBCR groups on patient-reported outcomes. METHOD/DESIGN: The study includes cancer patients in Alberta, exhibiting moderate distress, who do not have access to F2F MBCR. Participants will be randomized to either online MBCR, or waiting for the next available group. An anticipated sample size of 64 participants will complete measures online pre and post treatment or waiting period. Feasibility will be tracked through monitoring numbers eligible and participating through each stage of the protocol. DISCUSSION: 47 have completed/completing the intervention. Data suggest it is possible to conduct a randomized waitlist controlled trial of online MBCR to reach underserved cancer survivors. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01476891.

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