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Trial registered on ANZCTR


Registration number
ACTRN12617000081314
Ethics application status
Approved
Date submitted
5/01/2017
Date registered
16/01/2017
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an online mindfulness-based program for patients with melanoma
Scientific title
Feasibility of an online mindfulness-based program for patients with melanoma – Pilot RCT
Secondary ID [1] 290844 0
none
Universal Trial Number (UTN)
U1111-1191-3609
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 301519 0
Condition category
Condition code
Cancer 301240 301240 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296778 0
Behaviour
Intervention code [2] 296779 0
Treatment: Other
Intervention code [3] 296780 0
Lifestyle
Comparator / control treatment
The control group will only receive usual care, and will have access to the intervention at the end of the 6-week period.
Usual care for patients who have completed treatment for stage 2c or 3 melanoma (criteria for study eligibility) consist of quarterly follow-up visits, which comprise physical examination and PET (Positron Emission Tomography) scanning to monitor potential recurrences, new primaries, or metastatic disease.
Control group
Active

Outcomes
Primary outcome [1] 300656 0
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)
Timepoint [1] 300656 0
at study completion
Secondary outcome [1] 330513 0
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.
Timepoint [1] 330513 0
- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)
Secondary outcome [2] 330514 0
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).
Timepoint [2] 330514 0
- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)
Secondary outcome [3] 330515 0
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.
Timepoint [3] 330515 0
- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)
Secondary outcome [4] 330516 0
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.
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.
Timepoint [4] 330516 0
- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)
Secondary outcome [5] 330525 0
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.
Timepoint [5] 330525 0
- Baseline (pre-intervention)
- 6 weeks post-baseline (end of intervention)

Eligibility
Key inclusion criteria
Eligible patients will meet the following criteria:
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients in the following situation will be not be eligible:
- Waiting to start treatment for a melanoma recurrence or another primary
- Currently receiving treatment for a melanoma recurrence or another primary
- Diagnosed with distant metastasis (stage 4)
- Severe cognitive impairment or intellectual disability, as reported in the medical record or determined by the treating clinician or oncology nurse

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295279 0
University
Name [1] 295279 0
Deakin University
Address [1] 295279 0
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Country [1] 295279 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Country
Australia
Secondary sponsor category [1] 294102 0
None
Name [1] 294102 0
Address [1] 294102 0
Country [1] 294102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296611 0
Peter MacCallum Cancer Center Human Research Ethics Committee
Ethics committee address [1] 296611 0
305 Grattan Street
Melbourne Victoria
3000
Ethics committee country [1] 296611 0
Australia
Date submitted for ethics approval [1] 296611 0
07/09/2016
Approval date [1] 296611 0
04/01/2017
Ethics approval number [1] 296611 0
HREC/16/PMCC/139

Summary
Brief summary
This study will explore the feasibility of delivering an online 6-week mindfulness-based intervention (MBI) to patients with increased risk of melanoma recurrence.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have a melanoma diagnosis of stage 2c, 3a, 3b, or 3c, for which you have completed your last treatment within the past five years. You will also require access to the internet.

Study details
Participants in this study will be randomly allocated (by chance) to the 6-week online mindfulness based intervention (MBI) or usual care group. The MBI is designed to: (1) help patients understand the potential benefits of using mindfulness in their day to day life; and (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; (2) informal practice; and (3) formal meditation practice. Participants allocated to the usual care group will continue to receive their usual care for the first 6 weeks of the study, after which they will be offered the MBI.

All participants will be asked to complete questionnaires assessing fear of cancer recurrence, worry, rumination, stress and mindfulness before and after the 6-week study period. Intervention adherence, meditation quality and home tasks will also be assessed weekly. If this intervention proves to be feasible, and trends for changes in outcome measures are observed, a larger randomised-controlled study will be planned to assess intervention efficacy and cost-effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71470 0
Prof Trish Livingston
Address 71470 0
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Country 71470 0
Australia
Phone 71470 0
+61 3 9244 6609
Fax 71470 0
Email 71470 0
trish.livingston@deakin.edu.au
Contact person for public queries
Name 71471 0
Mrs Lahiru Russell
Address 71471 0
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Country 71471 0
Australia
Phone 71471 0
+61423694939
Fax 71471 0
Email 71471 0
lrussell@deakin.edu.au
Contact person for scientific queries
Name 71472 0
Mrs Lahiru Russell
Address 71472 0
Deakin University
221 Burwood Highway
Burwood 3125
Victoria
Country 71472 0
Australia
Phone 71472 0
+61423694939
Fax 71472 0
Email 71472 0
lrussell@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary