Authors
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Deakin University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: The intervention is a 9‐ week online mindfulness program called MindOnLine, which comprises three main components: (1) an educational component to increase participants' knowledge about the science and practice of mindfulness and how it can benefit them in everyday life; (2) a formal mindfulness meditation practice to improve awareness and emotion regulation; and (3) an informal practice to teach participants how to bring mindfulness to daily activities. Mindfulness education will be delivered using videos and associated video scripts. A new theme is introduced each week with a new meditation practice, which participants will be encouraged to practise every day. Themes include: introduction, reducing stress, relating to emotions, self‐compassion, communicating mindfully, living mindfully, reducing worry, reducing worries mindfully and maintaining mindfulness. Each video is approximately 5‐10 minutes in length. At the end of each week, participants will receive an email with a link to the video introducing the theme for the upcoming week. The script for the videos will be available for downloading and printing in a pdf format so that participants can keep a copy for later reference. At the end of each video, participants will be reminded by email to continue with their daily meditation practice (formal practice), and given specific informal practice during their daily activities. Examples of informal practice include: Week 1 – “This weeks, notice times you are aware; time you are fully engaged with what you are doing or giving your full attention to someone. And notice times you are not paying attention to the moment you are in; when you are distracted. See if you can notice the difference between these two modes of being.â€?; Week 2 – “notice CONDITION: Breast cancer;Prostate cancer;Colorectal cancer; ; Breast cancer ; Prostate cancer ; Colorectal cancer Cancer ‐ Bowel ‐ Back passage (rectum) or large bowel (colon) Cancer ‐ Bowel ‐ Small bowel (duodenum and ileum) Cancer ‐ Breast Cancer ‐ Prostate PRIMARY OUTCOME: Fear of cancer recurrence is the primary outcome of the study. The 42‐item Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional FCR scale intended for use with all cancer patients. Items were developed on the basis of a cognitive–behavioural formulation of FCR (range:0‐ 168)13. The FCRI consists of seven domains: triggers, severity, psychological distress, functional impairment, reassurance, insight and coping strategies (range:0‐36). It has shown high internal consistency, good construct and criterion validity in adults with different cancer types. [9‐weeks.] INCLUSION CRITERIA: Adult cancer survivors, aged 18+ years, diagnosed with breast, prostate or CRC, who have internet access, have completed treatment within the past 5 years, have internet access, and have a FCRI severity score equal to or greater than 13, indicative of clinically significant FCR. SECONDARY OUTCOME: Anxiety ‐ The GAD‐7 scale is a valid and efficient tool for screening for generalised anxiety disorder and assessing its severity in clinical practice and research. The seven items assess the frequency of core symptoms of generalized anxiety disorder within the past 2 weeks (range:0‐21).[9‐weeks] Depression ‐ The PHQ‐9 parallels the nine diagnostic symptom criteria that define DSM‐IV major depressive disorder. At only 9 items (range:0‐27), the PHQ‐9 is shorter than most depression tools. Unlike most other measures of depression, the PHQ‐9 was developed, tested and refined for use with medical patients.[9‐weeks] Economic evaluation ‐ Assessment of Quality of Life (AQoL 4D) is a health‐related quality of life utility measure. It generates quality‐adjusted life‐years used in economic evaluations and will assist with making judgements regarding value for money of the intervention compared with the control. The Resource Use Questionnaire (developed by CI Mihalopoulos) and her team to record service use and will form part of the economic evaluation. The questionnaire covers general health care services usage (self‐reported), use of other welfare services, and impacts on work force participation.[9‐months] Mindfulness ‐ Cognitive and Affective Mindfulness Scale‐Revised (CAMS‐R). Trait mindfulness is measured using the CAMS‐R, a 10 item self‐report questionnaire. This scale uses everyday language appropriate for those with little meditation experience, and is designed to capture mindfulness as a general daily experience. The questionnaire comprises four domains of mindfulness (attention, present‐focus, awareness, and acceptance/non‐judgment). Participants are asked to rate on a four‐point Likert scale how much they relate to each statement. Possible responses are 1=rarely/not at all; 2=sometimes; 3=often; 4=almost always (range:4‐40). Compared to other measures of mindfulness, the CAMS‐R is unique in that it is related to psychological distress,44 which is highly relevant to the current study population.[9‐weeks] Mindfulness experience ‐ participants in both groups will be asked whether they have enrolled in a mindfulness‐based program in the period between surveys and/or used other supportive care services (e.g. peer support, psychologists, psychotherapy, counsellors, yoga and meditation). Information will be collected using a written survey.[9‐weeks]
Epistemonikos ID: 8a2b35f26c04ab632b955f5939c4c28daf79285e
First added on: Aug 24, 2024