Dataset Information

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

ABSTRACT:

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.

Trial registration

Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.

SUBMITTER: Russell L

PROVIDER: S-EPMC5899401 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Russell Lahiru L Ugalde Anna A Milne Donna D Krishnasamy Meinir M O Seung Chul Eric E Austin David W DW Chambers Richard R Orellana Liliana L Livingston Patricia M PM

Trials 20180413 1

<h4>Background</h4>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 re ...[more]

PMID: 29653555

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Project description:INTRODUCTION:Residency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians' mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents' needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße. METHODS AND ANALYSIS:This study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8?weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents' self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6?months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling. ETHICS AND DISSEMINATION:The study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center 'SFB Muße 1015'. The results of this study will be published in scientific journals and disseminated through the study's website, and conferences. TRIAL REGISTRATION NUMBER:DRKS00014015.

Project description:Multiple sclerosis (MS) is a stressful condition. Mental health comorbidity is common. Stress can increase the risk of depression, reduce quality of life (QOL), and possibly exacerbate disease activity in MS. Mindfulness-Based Stress Reduction (MBSR) may help, but has been little studied in MS, particularly among more disabled individuals.The objective of this study was to test the feasibility and likely effectiveness of a standard MBSR course for people with MS. Participant eligibility included: age > 18, any type of MS, an Expanded Disability Status Scale (EDSS) </= 7.0. Participants received either MBSR or wait-list control. Outcome measures were collected at baseline, post-intervention, and three-months later. Primary outcomes were perceived stress and QOL. Secondary outcomes were common MS symptoms, mindfulness, and self-compassion.Fifty participants were recruited and randomised (25 per group). Trial retention and outcome measure completion rates were 90% at post-intervention, and 88% at 3 months. Sixty percent of participants completed the course. Immediately post-MBSR, perceived stress improved with a large effect size (ES 0.93; p < 0.01), compared to very small beneficial effects on QOL (ES 0.17; p = 0.48). Depression (ES 1.35; p < 0.05), positive affect (ES 0.87; p = 0.13), anxiety (ES 0.85; p = 0.05), and self-compassion (ES 0.80; p < 0.01) also improved with large effect sizes. At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were negligible for QOL (ES 0.08; p = 0.71), but were large for mindfulness (ES 1.13; p < 0.001), positive affect (ES 0.90; p = 0.54), self-compassion (ES 0.83; p < 0.05), anxiety (ES 0.82; p = 0.15), and prospective memory (ES 0.81; p < 0.05).Recruitment, retention, and data collection demonstrate that a RCT of MBSR is feasible for people with MS. Trends towards improved outcomes suggest that a larger definitive RCT may be warranted. However, optimisation changes may be required to render more stable the beneficial treatment effects on stress and depression.ClinicalTrials.gov Identifier NCT02136485 ; trial registered 1st May 2014.

Project description:BackgroundInterventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs.ObjectiveThis randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program.MethodsParticipants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed.ResultsIn the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice.ConclusionsThe program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance.ClinicaltrialClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).

Project description:IntroductionFear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted.Methods and analysisA single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs.Ethics and disseminationEthics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan.Trial registration numberAustralian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

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Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

Similar Datasets

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