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The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation.

ABSTRACT: Physical activity can improve many common side effects of cancer treatment as well as improve physical function and quality of life (QOL). In addition, physical activity can improve survival rate and reduce cancer recurrence. Despite these benefits, only 23% of cancer survivors in England are active to recommended levels. Cancer survivors are interested in lifestyle behavior change. Home-based interventions offer a promising means for changing physical activity behavior. Prediagnosis levels of physical activity and self-efficacy have been reported to be predictors of physical activity behavior change. The Move More Pack, which has undergone revision, is a printed resource with supporting Internet-based tools that aims to increase the physical activity of cancer survivors in the United Kingdom. The revised Move More Pack is underpinned by the theory of planned behavior and the social cognitive theory.The aim of this proposed study was to investigate the effect of the revised Move More Pack, supported by Internet-based tools, on physical activity, self-efficacy, and health-related QOL (HRQOL) of cancer survivors in the United Kingdom.This study is a two-arm waiting list randomized control trial with embedded process evaluation. A sample of 99 participants per arm will be recruited by invitation through an email database of cancer survivors held by UK charity Macmillan Cancer Support and an advert placed on the Macmillan Cancer Support Facebook page. Each participant is randomized to receive brief physical activity information and the UK guidelines for physical activity, or brief physical activity information and the revised Move More Pack with supporting Internet-based tools. The intervention and control arm will be followed up at 12 weeks to identify changes in self-reported physical activity, self-efficacy, and HRQOL based on Web-based questionnaires. The control arm will receive the revised Move More Pack at 12 weeks with follow-up at 24 weeks. The intervention arm is followed up at 24 weeks to determine maintenance of reported changes. Subgroup analyses will be completed based on participants' prediagnosis level of physical activity and baseline self-efficacy as possible predictors of positive changes. Use of each component of the revised Move More Pack will be assessed using a 4-point Likert scale. Semistructured phone interviews will evaluate the use and perceived usefulness of the revised Move More Pack.Participant recruitment started in March 2017. Projected completion of this study is October 2018.This study's findings will identify if the proposed low-cost broad reach intervention improves physical activity, self-efficacy, and the HRQOL of cancer survivors. The process evaluation is designed to contextualize the use and perceived usefulness of the revised Move More Pack, help augment its efficient distribution, and identify potential improvements to its design.

SUBMITTER: Webb J

PROVIDER: S-EPMC5701086 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation.

Webb Justin J Fife-Schaw Chris C Ogden Jane J Foster Jo J

JMIR research protocols 20171109 11

<h4>Background</h4>Physical activity can improve many common side effects of cancer treatment as well as improve physical function and quality of life (QOL). In addition, physical activity can improve survival rate and reduce cancer recurrence. Despite these benefits, only 23% of cancer survivors in England are active to recommended levels. Cancer survivors are interested in lifestyle behavior change. Home-based interventions offer a promising means for changing physical activity behavior. Predi ...[more]

PMID: 29122737

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Project description:BackgroundDue to early detection and advances in treatment, the number of women surviving breast cancer is increasing. Whilst there are many positive aspects of improved survival, breast cancer survival is associated with many long-term health and psychosocial sequelae. Engaging in regular physical activity post-diagnosis can reduce this burden. Despite this evidence, the majority of breast cancer survivors do not engage in regular physical activity. The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way. This article describes the protocol for the Move More for Life Study, which aims to assess the relative efficacy of two promising theory-based, print interventions designed to promote regular physical activity amongst breast cancer survivors.Method and designBreast cancer survivors were recruited from across Australia. Participants will be randomised into one of three groups: (1) A tailored-print intervention group, (2) a targeted-print intervention group, or (3) a standard recommendation control group. Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period. Participants in the targeted-print group will receive a previously developed physical activity guidebook designed specifically for breast cancer survivors immediately after baseline. Participants in the standard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults. All participants will be assessed at baseline, and at 4 and 10 months post-baseline. Intervention efficacy for changing the primary outcomes (mins/wk aerobic physical activity; sessions/exercises per week resistance physical activity) and secondary outcomes (steps per day, health-related quality life, compliance with physical activity guidelines, fatigue) will be assessed. Mediation and moderation analyses will also be conducted.DiscussionGiven the growing number of cancer survivors, distance-based behaviour change programs addressing physical activity have the potential to make a significant public health impact.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12611001061921.

Project description:BackgroundDelays in starting physical therapy after hospital discharge worsen deconditioning in older adults. Intervening quickly can minimize the negative effects of deconditioning. Telerehabilitation is a strategy that increases access to rehabilitation, improves clinical outcomes, and reduces costs. This paper presents the protocol for a pragmatic clinical trial that aims to determine the effectiveness and cost-effectiveness of a multi-component intervention offered by telerehabilitation for discharged older adults awaiting physical therapy for any specific medical condition.MethodsThis is a pragmatic randomized controlled clinical trial with two groups: telerehabilitation and control. Participants (n=230) will be recruited among individuals discharged from hospitals who are in the public healthcare system physical therapy waiting lists. The telerehabilitation group will receive a smartphone app with a personalized program (based on individual's functional ability) of resistance, balance, and daily activity training exercises. The intervention will be implemented at the individuals' homes. This group will be monitored weekly by phone and monthly through a face-to-face meeting until they start physical therapy. The control group will adhere to the public healthcare system's usual flow and will be monitored weekly by telephone until they start physical therapy. The primary outcome will be a physical function (Timed Up and Go and 30-s Chair Stand Test). The measurements will take place in baseline, start, and discharge of outpatient physical therapy. The economic evaluations will be performed from the perspective of society and the Brazilian public healthcare system.DiscussionThe study will produce evidence on the effectiveness and cost-effectiveness of multi-component telerehabilitation intervention for discharged older adult patients awaiting physical therapy, providing input that can aid the implementation of similar proposals in other patient groups.Trial registrationBrazilian Registry of Clinical Trials (ReBEC), RBR-9243v7 . Registered on 24 August 2020.

Project description:ImportanceWith continuing improvements in medical devices and more than a decade since the 2006 United Network for Organ Sharing (UNOS) allocation policy, it is pertinent to assess survival among patients on the heart transplantation waiting list, especially given the recently approved 2018 UNOS allocation policy.ObjectivesTo assess survival outcomes among patients on the heart transplant waiting list during the past 3 decades and to examine the association of ventricular assist devices (VADs) and the 2006 UNOS allocation policy with survival.Design, setting, and participantsA retrospective cross-sectional used the UNOS database to perform an analysis of 95 323 candidates wait-listed for heart transplantation between January 1, 1987, and December 29, 2017. Candidates for all types of combined transplants were excluded (n = 2087). Patients were followed up from the time of listing to death, transplantation, or removal from the list due to clinical improvement. Competing-risk, Kaplan-Meier, and multivariable Cox proportional hazards regression analyses were used.Main outcomes and measuresThe analysis involved an unadjusted and adjusted survival analysis in which the primary outcome was death on the waiting list. Because of changing waiting list preferences and policies during the study period, the intrinsic risk of death for wait-listed candidates was assessed by individually analyzing, comparing, and adjusting for several candidate risk factors.ResultsIn total, 95 323 candidates (72 915 men [76.5%]; mean [SD] age, 51.9 [12.0] years) were studied. In the setting of changes in listing preferences, 1-year survival on the waiting list increased from 34.1% in 1987-1990 to 67.8% in 2011-2017 (difference in proportions, 0.34%; 95% CI, 0.32%-0.36%; P < .001). The 1-year waiting list survival for candidates with VADs increased from 10.2% in 1996-2000 to 70.0% in 2011-2017 (difference in proportions, 0.60%; 95% CI, 0.58%-0.62%; P < .001). Similarly, in the setting of changing mechanical circulatory support indications, the 1-year waiting list survival for patients without VADs increased from 53.9% in 1996-2000 to 66.5% in 2011-2017 (difference in proportions, 0.13%; 95% CI, 0.12%-0.14%; P < .001). In the decade prior to the 2006 UNOS allocation policy, the 1-year waiting list survival was 51.1%, while in the decade after it was 63.9% (difference in proportions, 0.13%; 95% CI, 0.12%-0.14%; P < .001). In adjusted analysis, each time period after 1987-1990 had a marked decrease in waiting list mortality.Conclusions and relevanceThis study found temporally associated increases in heart transplant waiting list survival for all patient groups (with or without VADs, UNOS status 1 and status 2 candidates, and candidates with poor functional status).

Project description:IntroductionPersistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England's annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.Methods and analysisA cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to 'integrated GP care plus treatment as usual' or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks' postrandomisation, using a mixed-methods approach.Ethics and disseminationEthical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.Trial registration numberNCT02444520; Pre-results.

Project description:BACKGROUND:Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. OBJECTIVE:The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. METHODS:The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. RESULTS:Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. CONCLUSIONS:This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF. TRIAL REGISTRATION:Netherlands Trial Register NL6642; https://www.trialregister.nl/trial/6642. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15969.

Project description:BACKGROUND:Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions' clinical efficacy and potential underlying mechanisms. DESIGN:Forty-five adults who are either overweight or obese (minimum body mass index of 25 kg/m2) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8 weeks) and follow-up (12 weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded. DISCUSSION:Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.

Dataset Information

The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation.

Publications

The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation.

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