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Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial

Russell, Lahiru, Ugalde, Anna, Milne, Donna, Krishnasamy, Meinir, O (Seung Chul), Eric, Austin, David W, Chambers, Richard, Orellana, Liliana and Livingston, Patricia M 2018, Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial, Trials, vol. 19, no. 1, doi: 10.1186/s13063-018-2575-x.

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Title Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial
Author(s) Russell, Lahiru
Ugalde, AnnaORCID iD for Ugalde, Anna orcid.org/0000-0002-2473-8435
Milne, Donna
Krishnasamy, Meinir
O (Seung Chul), Eric
Austin, David WORCID iD for Austin, David W orcid.org/0000-0002-1296-3555
Chambers, Richard
Orellana, LilianaORCID iD for Orellana, Liliana orcid.org/0000-0003-3736-4337
Livingston, Patricia MORCID iD for Livingston, Patricia M orcid.org/0000-0001-6616-3839
Journal name Trials
Volume number 19
Issue number 1
Article ID 223
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2018-04-13
ISSN 1745-6215
Keyword(s) Cancer
Feasibility
Internet-based
Melanoma
Mindfulness
Pilot
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
STATE WORRY QUESTIONNAIRE
STRESS REDUCTION MBSR
QUALITY-OF-LIFE
CANCER RECURRENCE
PSYCHOMETRIC PROPERTIES
INITIAL VALIDATION
MEDITATION
FEAR
RUMINATION
INTERVENTIONS
Summary Background
People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial.

Methods/design
This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5–10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments.

Discussion
This feasibility study will evaluate participants’ satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing.
Language eng
DOI 10.1186/s13063-018-2575-x
Field of Research 111099 Nursing not elsewhere classified
111299 Oncology and Carcinogenesis not elsewhere classified
119999 Medical and Health Sciences not elsewhere classified
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Socio Economic Objective 920408 Health Status (e.g. Indicators of Well-Being)
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2018, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30107674

Document type: Journal Article
Collections: School of Nursing and Midwifery
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.