Dataset Information

Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol.

ABSTRACT:

Introduction

Physically active cancer survivors have substantially less cancer recurrence and improved survival compared with those who are inactive. However, the majority of survivors (70%-90%) are not meeting the physical activity (PA) guidelines. There are also significant geographic inequalities in cancer survival with poorer survival rates for the third of Australians who live in non-metropolitan areas compared with those living in major cities. The primary objective of the trial is to increase moderate-to-vigorous PA (MVPA) among cancer survivors living in regional and remote Western Australia. Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors. Tertiary objectives are to assess the effectiveness of the health action process approach (HAPA) model variables, on which the intervention is based, to predict change in MVPA.

Methods and analysis

Eighty-six cancer survivors will be randomised into either the intervention or control group. Intervention group participants will receive a Fitbit and up to six telephone health-coaching sessions. MVPA (using Actigraph), QoL and psychological variables (based on the HAPA model via questionnaire) will be assessed at baseline, 12?weeks (end of intervention) and 24?weeks (end of follow-up). A general linear mixed model will be used to assess the effectiveness of the intervention.

Ethics and dissemination

Ethics approval has been obtained from St John of God Hospital Subiaco (HREC/#1201). We plan to submit a manuscript of the results to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital research conferences.

Trial registration number

ACTRN12618001743257; pre-results, U1111-1222-5698.

SUBMITTER: Hardcastle SJ

PROVIDER: S-EPMC6538194 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol.

Hardcastle Sarah J SJ Hince Dana D Jiménez-Castuera Ruth R Boyle Terry T Cavalheri Vinicius V Makin Greg G Tan Patrick P Salfinger Stuart S Tan Jason J Mohan Ganendra Raj GR Levitt Michael M Cohen Paul A PA Saunders Christobel C Platell Cameron C

BMJ open 20190524 5

<h4>Introduction</h4>Physically active cancer survivors have substantially less cancer recurrence and improved survival compared with those who are inactive. However, the majority of survivors (70%-90%) are not meeting the physical activity (PA) guidelines. There are also significant geographic inequalities in cancer survival with poorer survival rates for the third of Australians who live in non-metropolitan areas compared with those living in major cities. The primary objective of the trial is ...[more]

PMID: 31129600

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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:IntroductionPhysical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.Methods and analysisThis trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. A total of 50 patients will be randomised to one of the two interventions and will follow a 3-month programme with a 6-month follow-up postintervention. The primary outcome of the study is the daily step count change between the baseline assessment and the end of the intervention. Accelerometer data, self-reported PA, body composition and physical capacities will also be evaluated. To advance our understanding of complex interventions like gamified and group-based ones, we will explore several psychological mediators relative to motivation, enjoyment, in-group identification or perceived weight stigma. Finally, to assess a potential superior economic efficiency compared with the current treatment, we will conduct a cost-utility analysis between the two conditions. A mixed-model approach will be used to analyse the change in outcomes over time.Ethics and disseminationThe research protocol has been reviewed and approved by the Local Human Protection Committee (CPP Ile de France XI, No 21 004-65219). Results will inform the Kiplin app development, be published in scientific journals and disseminated in international conferences.Trial registration numberNCT04887077.

Project description:IntroductionMobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists.Methods and analysisThis pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other.Ethics and disseminationEthical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers.Trial registration numberACTRN12618001983291.

Project description:ObjectiveTo systematically evaluate the effects of physical activity in adult patients after completion of main treatment related to cancer.DesignMeta-analysis of randomised controlled trials with data extraction and quality assessment performed independently by two researchers.Data sourcesPubmed, CINAHL, and Google Scholar from the earliest possible year to September 2011. References from meta-analyses and reviews.Study selectionRandomised controlled trials that assessed the effects of physical activity in adults who had completed their main cancer treatment, except hormonal treatment.ResultsThere were 34 randomised controlled trials, of which 22 (65%) focused on patients with breast cancer, and 48 outcomes in our meta-analysis. Twenty two studies assessed aerobic exercise, and four also included resistance or strength training. The median duration of physical activity was 13 weeks (range 3-60 weeks). Most control groups were considered sedentary or were assigned no exercise. Based on studies on patients with breast cancer, physical activity was associated with improvements in insulin-like growth factor-I, bench press, leg press, fatigue, depression, and quality of life. When we combined studies on different types of cancer, we found significant improvements in body mass index (BMI), body weight, peak oxygen consumption, peak power output, distance walked in six minutes, right handgrip strength, and quality of life. Sources of study heterogeneity included age, study quality, study size, and type and duration of physical activity. Publication bias did not alter our conclusions.ConclusionsPhysical activity has positive effects on physiology, body composition, physical functions, psychological outcomes, and quality of life in patients after treatment for breast cancer. When patients with cancer other than breast cancer were also included, physical activity was associated with reduced BMI and body weight, increased peak oxygen consumption and peak power output, and improved quality of life.

Project description:IntroductionSystematic reviews reporting self-management interventions are associated with significant improvements in stroke survivors' self-efficacy, health-related quality of life (HRQoL) and independence. However, common barriers such as transportation and availability of carers were identified. Health coaching is suggested as an innovative and cost-effective care model with potential benefits in managing chronic diseases. A randomised controlled trial is proposed to evaluate the effectiveness of an enhanced self-management programme by health coaches on stroke survivors' recovery outcomes.Methods and analysisAll adult community-dwelling stroke survivors with a modified Rankin Scale Score ≥3 will be recruited from a community rehabilitation network. Eligible participants will be randomly allocated to receive either the enhanced stroke self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY [COMBO-KEY]) plus usual care or usual care only. COMBO-KEY is an 8-week programme underpinned by Bandura's principles of self-efficacy and outcome expectation. It consists of four home visits and five phone-coaching sessions delivered by trained health coaches. Each participant will receive a resource package containing a workbook, a quick reference guide, a planning toolkit and 15 videos of peer survivors' stroke survival experience. Survivors' outcomes include self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours, HRQoL, depressive symptoms and community reintegration. Assessment will be conducted at baseline and immediately after completing the programme. Generalised estimating equations' model will be used to analyse the data.DiscussionIt is anticipated that the programme will build community capacity in supporting stroke survivors. The results will shed light on integrating the programme into the current stroke rehabilitation services.Ethics and disseminationThe Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has approved this protocol (CREC Ref. No.: 2018.009). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.Trial registration numberClinicalTrials.gov Identifier: NCT03741842; Pre-results.

Dataset Information

Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol.

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