Dataset Information

Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS) using Wearable technology and telephone health-coaching: Randomised Controlled Trial

ABSTRACT: 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

DISEASE(S): Cancer Survivors,Cancer-bowel-anal,Cancer-bowel-small Bowel (duodenum And Ileum),Cancer-bladder,Cancer-cervical (cervix),Cancer-prostate,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-breast

PROVIDER: 2468135 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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

Project description:Interventions: The intervention arm is named HoPS, an acronym of Home-based Physical Activity for Survivors. HoPS intervention programme aims to improve physical activity level among cancer survivors, in particular breast and colorectal cancer by employing Social Cognitive Theory (SCT) in the development of the programme. It combines of psychoeducation and social media approach to behavioural intervention. Participants of the HoPS will be provided with a non-tailored printed material and gradual tapering down of face-to-face group meetings to improve knowledge and skills of physical activity. While WhatsApp is used as a structured direct remote feedback strategy to allow for supervised home-based physical activity. 1. Face-to-face group meetings There will be 2 meet up sessions for all participants in the HoPS group. The sessions provide a standardized lectures deliver by the researcher using power point slides. The first session of lecture (1-hour duration) will cover the areas of a brief introduction of HoPS programme, physical activity knowledge and goal setting. The second session of lecture (15-minutes duration) will cover for barriers to physical activity and following that a sharing session (15-minutes duration) by a role model (a cancer survivor) to share her experience in engaging in physical activity. In each of the sessions, after the lectures, an exercise session will be conducted by a certified exercise instructor with at least 3 years experienced in coaching for exercise. The duration of this exercise session will be 2 hours and the focus is train the participants on how to perform a proper and correct exercise for cancer survivors. This will involved aerobic exercises and resistance exercis Primary outcome(s): Total MET-minutes/week using validated IPAQ [Baseline, at 8-week (immediately after intervention) and at 16-week post intervention] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Participants will undergo preoperative baseline screening and will be randomised to either normal postoperative care or a 12-week supervised exercise programme comprising of both an aerobic and resistance component They will be assessed prior to surgery which will include cardiopulmonary exercise testing (CPET). This is a well-established method of assessing aerobic exercise response and is widely used in the perioperative period for assessment of cancer patients with co-morbidity. The assessment days will also include: * muscle ultrasound (vastus lateralis) to ascertain muscle structure (thickness, pennation angle and fascicle length), * blood tests, * functional composite scores, * quality of life questionnaires, The assessment days will be carried out at four time points during the study; prior to surgery, before commencement of the exercise program, halfway through the intervention (6 weeks post commencement of exercise) and at the end of the study. In the week before the assessment days patients will wear a physical activity monitor to characterise their daily movements. The control group will also be assessed at the same time points and wear the activity monitors but will not take part in the exercise program. All participants will have a physical activity monitor placed onto the right thigh in the midline at postoperative day 1 until discharge or day 7, whichever is sooner. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. Once participants self-report feeling able to start exercising again post-discharge, they will commence the 12 week programme. The intervention will consist of 2 resistance training (RET) sessions per week and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (can be split according to patient preference). They will receive a diary to log their sessions and will be monitored via twice weekly virtual follow-up (either telephone or video calling) and for the first 6 weeks weekly visits to ensure that they are adherent to the exercise protocol and provide any support/advice. Satisfactory compliance with the programme will be considered to be the completion of at least 27 sessions over the 12 week period, with a minimum of 13 out of 18 and 14 out of 18 sessions completed in the first and last 6 weeks, respectively.

Project description:Background/Purpose: Prior studies show an independent association between greater physical activity and lower inflammatory markers among adults in the general population, but the impact of physical activity on systemic inflammation in people with rheumatoid arthritis (RA) hasn’t been thoroughly investigated. We therefore aimed to determine whether physical activity behavior associates with differential expression of inflammatory genes in RA. Methods: Data derive from baseline assessments for a prospective observational cohort of patients with RA. At each study visit, we obtained detailed clinical information, collected peripheral whole blood for subsequent RNA sequencing (RNA-seq), and provided participants with actigraphs (GT9X ActiGraph Link device) to objectively measure physical activity by wearing the device at home for 7 consecutive 24-hour periods. Participants were categorized into three physical activity groups based on the highest (“active”), middle (“intermediate”), and lowest (“inactive”) tertiles for percentage of time spent in moderate/vigorous physical activity (metabolic equivalent (MET) level ≥2.00) across the sample. Results: There were 35 patients with complete clinical, actigraphy, and transcriptomic data available for analysis. The participants had a mean age of 56 years, were 90% female, and self-reported the following racial/ethnic identities: 32% white, 11% African American, 8% Asian, 40% Hispanic. Participants spent 48%, 41%, and 12% of time awake in sedentary, light, and moderate physical activity, respectively. None of the participants achieved vigorous activity. The patients in the most active group were younger but did not otherwise significantly differ by clinical and demographic characteristics compared to the other physical activity groups. However, in the differential gene expression analysis comparing the highest versus lowest physical activity tertiles, there were 365 up- and 402 down-regulated genes at an adjusted P value < 0.1. Gene set enrichment analysis revealed that the most physically active patients exhibited downregulation of diverse innate and adaptive immune signaling pathways. Assessment of upstream cytokine activation states demonstrated inhibition of type I, II and III interferons and activation of EPO in the highest physical activity tertile patients. Conclusion: Among a racially and ethnically diverse RA cohort, participants who spent more time in moderately intense physical activity had down-regulation of genes involved in both innate and adaptive immune signaling compared to those who were more sedentary. These findings provide mechanistic evidence to support a disease-modifying effect of physical activity in RA.

Project description:Some studies have shown that acute intake of high-phenol virgin olive oil reduces pro-inflammatory, pro-oxidant and pro-thrombotic states, but nowadays still remains unclear if those effects attributed to its phenolic fraction could be exerted at transcriptional level in vivo. Two virgin olive oil-based breakfasts with high (398 ppm) and low (70 ppm) content of phenolic compounds were administered to twenty patients (9 men and 11 women) with metabolic syndrome following a double-blinded random crossover design. Prior to the first breakfast intervention, participants followed a 6-week washout period in which they were instructed to not take vitamins, soy supplements, or any drug. To eliminate the potential effect that might exist in their usual dietary habits, all subjects followed a low-fat, carbohydrate rich (CHO) diet during this period and untill the end of the study. In the 24 h before each breakfast intervention, participants were instructed to avoid consuming phenol-rich foods such as fruit or juices, wine, grape juice, chocolate, coffee, tea, olive oil, or soya, and to refrain from intense physical exercise during that period. After a 12 h fasting and following a randomized sequential crossover design with one-week washout period, participants reported to the hospital and received two fat meals consisting of 60 g of white bread, 40 mL of VOO (CANOLIVA®, Antonio Cano e Hijos™, Córdoba, Spain) with high (398 ppm) or low (70 ppm) content in phenolic compounds, and 60,000 IU of vitamin A per m2 of body surface. Olive oil with low content in phenolic compounds was obtained as a result of extraction by physical procedures of most of the phenolic compounds in the high-phenol olive oil, so that both oils kept a similar composition of the remaining macro- and micronutrients. Throughout the 4-h duration of the study, the subjects performed no physical activity, nor did they consume anything but water. Gene expression was performed on peripheral blood mononuclear cells (PBMCs) at postprandial period (4 hours after breakfast) by microarray analysis and verified by qRT-PCR. Two sets of dye-swaped experiments were performed making a total of four technical replicates per subject. Each of the hybridizations compared total RNA from PBMCs obtained 4h after the intake of virgin olive oil with high phenolic content vs. total RNA from PBMCs obtained 4h after low-phenol virgin olive oil consumption.

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Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS) using Wearable technology and telephone health-coaching: Randomised Controlled Trial

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