Dataset Information

Wearable Activity Technology And Action-Planning (WATAAP) trial to promote physical activity in colorectal and endometrial cancer survivors at cardiovascular risk

ABSTRACT: Interventions: The intervention arm will receive a Fitbit to use to monitor physical activity for the duration of the 12-week intervention. Participants who are randomised to the intervention arm will also attend two group sessions which will target goal-setting and action-planning skills. The treatment group will be able to collect the Fitbit post-randomisation. Participants will be able to pick the Fitbit up from the hospital, signing it out upon collection at their first group meeting. They will be asked to wear the Fitbit as much as possible during the 12-week intervention (at least 8 hours per day, preferably all waking hours), and will be encouraged to download Fitbit software that will assist in tracking their physical activity. Use of the Fitbits will provide participants with a practical and convenient method for monitoring their activity. Throughout the 12-week intervention, participants in the treatment group will be required to attend two 1-hour group sessions. The first group session will be held in week 1, and the second in week 4 of the study. Session one will focus on introducing participants to the Fitbit and giving instructions on how to use this device as a self-monitoring tool. Participants will complete goal-setting worksheets (Appendix F - attached to ANZCTR registration form) to set their activity goals for the following 12 weeks. Behaviour change specialists SH and CMS will assist participants with effective action planning, goal-setting and self-monitoring. Session two will attend to support needs and help participants to plan for and overcome barriers to increasing their physical activity level. Participants will also be able to adjust previously established goals, if necessary. This session will also allow for trouble-shooting of any problems or queries that participants encounter regarding Fitbit wear and use. Participants will take all worksheets from the sessions home with them, to assist with achieving their goals. At the end of the Primary outcome(s): Minutes of activity per week as measured by accelerometer wear for 7 days. [12 weeks after baseline];Minutes of sedentary time as measured by accelerometer wear for 7 days.[12 weeks after baseline. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Cancer-womb (uterine Or Endometrial Cancer),Cardiovascular Risk,Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer

PROVIDER: 2464902 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The intervention will include (I) providing a wearable tracker; (ii) up to six individual telephone or social media based sessions of health coaching. and (iii) a booklet with physical activity information and motivational tools to support behaviour change. The wearable tracker will be a wrist worn Fitbit Charge 2. Participants will be encouraged to wear the Fitbit during all waking hours, except for showering or swimming. However, it is not mandatory to wear the Fitbit during all waking hours. Participants will choose mode of delivery according to their preferences from a choice of telephone, Skype, zoom, or messenger etc. This is a distance-based intervention. Therefore the wearable tracker will be mailed to participants. Four sessions of health coaching are fixed (at wk 1, 2, 4 and 8) for all participants and will last up to 45 minutes each. However, the intervention includes a patient-centred and stepped-care approach by providing additional health coaching sessions (i.e., at wk 6, and 10) to those who may need them in order to achieve meaningful sustained physical activity change. A Health coach will be employed to deliver the intervention and will be required to have a background in Psychology or allied health discipline (at least to degree level), and previous experience of interviewing or working with patients. There is no specific exercise prescription but participants will be encouraged to meet the physical activity guidelines for cancer survivors, which is at least 150 minutes of moderate-intensity physical activity per week. They will also be informed that 3-5 hours of moderate-intensity physical activity will bring maximum benefits and will be encouraged to reach this goal once achieve the minimum guidelines of 150-minutes per week. The purpose of the health coaching is to motivate and support increased physical activity through supporting self-efficacy, action planning, and coping planning. The first session will cover technical issues and featu Primary outcome(s): The primary outcome is Minutes of Moderate to vigorous physical activity per week assessed using an accelerometer (the Actigraph GT9 X). At each assessment point, participants will be mailed the Actigraph and asked to wear the device on their hip or waist for a period of 7 consecutive days during all waking hours.[week 12 post baseline assessment];Change in minutes of sedentary behaviour per week, also assessed using the Actigraph GT9X . Sedentary behaviour will be defined by accelerometer activity counts of <100 counts per minute, for 20 consecutive minutes or more.[week24 post baseline assessment] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:<p>Andersen-Tawil syndrome (ATS) is an ion channel disorder that causes episodes of muscle weakness and potentially life-threatening heart arrhythmias. The majority of ATS cases are caused by a mutation in the KCNJ2 gene, which is linked to potassium channels in the heart, brain, and skeletal muscle; other cases are presumed to be caused by an undetermined gene lesion. To date, the treatment for ATS has been largely anecdotal, and no treatments have been formally assessed in a controlled clinical trial. This study will determine whether potassium supplements and/or acetazolamide, which is a diuretic medication, affect the duration of muscle weakness and heart rhythm abnormalities in people with ATS.</p> <p>Participation in this study will last about 11 months. Participants will first attend a 3-day inpatient visit that will include a medical history, physical examination, blood work, heart rhythm testing by an electrocardiogram (ECG) and Holter monitor, strength testing, a health questionnaire, and daily potassium supplementation. Participants will also track the number and length of weakness episodes that they experience while in the hospital. On the last day of the inpatient visit, participants will be provided with multiple bottles containing either potassium or placebo. Participants will then return home for an 18-week treatment period that will consist of six 3-week-long treatments of either potassium or placebo, with the treatment schedule being randomly determined. Upon completing the first 18-week treatment period, participants will attend a second 3-day inpatient visit that will include the same tests and procedures as the first. The only difference will be that participants will receive acetazolamide along with potassium. This will be followed by a second 18-week treatment period that will consist of six 3-week-long treatments of either acetazolamide or placebo. At the end of the second treatment period, participants will fill out another health questionnaire. Throughout both 18-week treatment periods, participants will phone in daily to track any muscle or heart problems. They will also provide blood samples on a weekly basis. At Weeks 2, 5, 8, 11, 14, and 17 of both treatment periods, participants will wear a Holter monitor for 24 hours and then mail it in. A final outpatient visit will occur 8 weeks after the end of the second treatment period and will include heart rhythm testing, muscle strength testing, and blood work.</p>

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Wearable Activity Technology And Action-Planning (WATAAP) trial to promote physical activity in colorectal and endometrial cancer survivors at cardiovascular risk

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