Authors
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Deakin University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2017
INTERVENTION: The intervention is a 6‐week online mindfulness‐based program designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; (2) support the establishment of daily meditation practice. Each week of the program explores a different topic, which builds on the topic explored the week before. The program includes three main components: (1) educational component – weekly themes related to the application of mindfulness. Participants are invited to watch at the beginning of each week, a series of videos (the number varies for each week), each 40 seconds to 60 seconds long. The scripts of those videos can be downloaded if participants wish to refer to the information at a later stage; (2) informal practice. Participants are given a weekly mindfulness‐based task to practice during their daily activities; and (3) formal meditation practice. Participants are asked to practice meditation twice daily for 5 minutes each time. This time is increased to 10 minutes each practice from week 3 onwards. Participants will receive an email at the start of each week with a link to a brief questionnaire inquiring about their level of engagement with the program. Following completion of the questionnaire, participants will be directed to a video introducing the theme for the upcoming week. At the end of each video, participants will be reminded to keep up with their daily meditation practice (formal practice), and will be given a specific mindfulness task to practice during their daily activities (informal practice). To support participants with establishing a meditation routine, emails containing a link to a short, guided meditation audio file will be sent to participants twice daily. These emails will serve as reminders to meditate and will provide easy access to the meditation practice of the week. The website will have a section addressing common questions about meditation, which participants will be able to consult at any time throughout the course of the program. The mindfulness program can be accessed at any time via direct login to the Website or via the hyperlink sent to participants in the weekly e‐mails. The software used to run the mindfulness program will allow tracking of participants’ online activity, including login date/times, navigation patterns, page views and duration, and features used (video, audio, and document downloads). A set of three questions will be presented weekly to capture information on any use of other types of meditation unrelated to the intervention, and frequency of practice. Another three questions will estimate the amount of informal practice over the past week, and the specific use of the weekly topic, using a 5‐point Likert scale. These questions will be presented to users at the end of each week, prior to the introduction of the next weekly topic. CONDITION: Melanoma PRIMARY OUTCOME: Study feasibility as determined through: ; ‐ overall recruitment (ratio of patients completing the baseline questionnaires over those approached for the study), retention across the six weeks and extent of completion of all questionnaire items described under "secondary outcomes" (ratio of participants who complete the post 6‐week study period questionnaire over those who have completed the baseline questionnaire) . ; ‐ adherence to the program (online monitoring and weekly questionnaire on meditation and mindfulness‐based practice ‐ questionnaire specifically designed for the study) ; ‐ program content relevance (questionnaire specifically designed for the study) ; ; Compared to other measures of mindfulness, the CAMS‐R is unique in that it is related to psychological distress, which is highly relevant to the current study population. INCLUSION CRITERIA: Eligible patients will meet the following criteria: SECONDARY OUTCOME: Cognitive and Affective Mindfulness Scale‐Revised (CAMS‐R) is a 10 item self‐report questionnaire measuring trait mindfulness.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). Patients 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. ; Fear of cancer recurrence Inventory (FCRI), a 42‐item questionnaire. It is a multidimensional scale intended for use with all cancer patients. The FCRI consist of seven domains: triggers, severity, psychological distress, functional impairment, reassurance, insight and coping strategies. It has shown high internal consistency, and good construct and criterion validity in a group of adults with different cancer types, and in 286 adults with a history of melanoma. ; Penn State Worry Questionnaire ‐ Abbreviated (PSQW‐A) is an 8‐item scale that will assess trait worry by capturing the excessiveness, prevalence, and uncontrollability of clinically worry. Items on the PSWQ‐A are rated from 1 (not at all) to 5 (very typical) and total scores range from 8 to 40,with higher scores indicating greater worry. The PSWQ‐A is a valid and reliable measure for use among older adults and women with cancer with internal consistency of 0.87 and 0.96 respectively. ; Perceived Stress Scale (PSS10) is a self‐report questionnaire measuring the global perception of stress. The items were designed to evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale has internal consistency ranging from 0.75 to 0.86. Consistent with this range, studies measuring perception of stress in people with prostate cancer and breast cancer had Cronbach’s alpha of 0.78 and 0.87 respectively. ; Rumination subscale (RRQ‐Rum) is a 12‐item questionnaire that will measure “ruminative self‐attention,” the tendency to dwell on, rehash, or re‐evaluate events or experiences. Items are rated on a 5‐point Likert scale from “strongly disagree” (1) to “strongly agree” (5). The scale showed good internal reliability in a sample of newly diagnosied colon cancer patients and mixed cancer patients (Cronbach’s alpha = 0.90 and 0.92, respectively). ‐ Have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c ‐ Have completed their last treatment within the past five years ‐ Aged 18 years or over ‐ Sufficient understanding of English to consent and participate ‐ Have access to internet ‐ Have an email account or willing to create one for the study ‐ Willing to commit to a 6‐week program and to completing brief assessment measures.
Epistemonikos ID: fb5c52aaeccd6c41a2ae5b5172f115a1ceafb9c9
First added on: Aug 25, 2024