Understanding the associations between receipt of, and interest in, advice from a healthcare professional and quality of life in individuals with a stoma from colorectal cancer: a latent profile analysis.

PURPOSE: To explore whether profiles derived from self-reported quality of life were associated with receipt of, and interest in, advice from a healthcare professional in people with a stoma. METHODS: Secondary analysis of cross-sectional national survey data from England of 4487 people with a stoma from colorectal cancer. The survey assessed quality of life using various scales, receipt and interest in various forms of advice, and physical activity. A three-step latent profile analysis was conducted to determine the optimum number of profiles. Multinomial regression explored factors associated with profile membership. A series of logistic regression models examined whether profile membership was associated with interest in advice. RESULTS: Five profiles were identified; 'consistently good quality of life', 'functional issues', 'functional and financial issues', 'low quality of life' and 'supported but struggling'. Individuals in the 'functional and financial issues' and 'low quality of life' profiles were more likely to have received financial advice compared to the 'consistently good quality of life' profile. When compared to the 'consistently good quality of life' profile, all other profiles were more likely to report wanting advice across a range of areas, with the strongest associations in the 'low quality of life' profile. CONCLUSION: Findings indicate that people with a stoma are not a homogenous group in terms of quality of life. Participants in profiles with quality of life concerns report wanting more advice across various categories but findings suggest there is scope to explore how this can be tailored or adapted to specific groups.

Lived Experience of Parastomal Bulging: A Mixed Methods Study.

Aim: This United Kingdom study aimed to explore people's experiences of living with, and self-managing parastomal bulging. Methods: Seventeen people were interviewed and 61 people completed an online survey. Results: Parastomal bulging has a detrimental impact on quality of life including a negative impact on stoma function, daily activities, body image, physical intimacy, and socialising; access to specialist information and support for addressing the problem of bulging was inequitable; support garments were the most common self-management intervention; there was confusion about what exercise would be beneficial or how being active would help in terms of parastomal bulging self-management; peer support is no substitute for high quality specialist support. Conclusion: People need equitable access to information and support to self-manage and treat parastomal bulging. Research about other types of self-management interventions, for example, exercise is required so that people do not have to rely solely on support garments to self-manage parastomal bulging.

Hernia Active Living Trial (HALT): an exercise intervention in people with a parastomal hernia or bulge.

BACKGROUND: Parastomal hernias are a common consequence of stoma surgery and can occur in up to 50% of patients. They are mangaged either conservatively, through support hosiery, or surgically. A patient feasibility study called the Hernia Active Living Trial (HALT) was designed to examine if a clinical pilates-based exercise programme offers an alternative approach to managing a parastomal hernia or bulge. METHOD: Adults with an ileostomy or colostomy who perceived they had a bulge around their stoma were included in the study. The intervention included up to 12 online sessions of an exercise booklet and videos with an exercise specialist. Interviews were conducted to explore participants' experiences of the intervention. The interview data were analysed systematically and thematically. Participants were also asked to complete patient diaries every week. RESULTS: Twelve of the 13 participants who completed the intervention agreed to be interviewed. Following analysis, three main themes emerged including managing a hernia/bulge, benefits and barriers. Participants talked about the benefits of this programme including: reduction of the size of their hernia, increased abdominal control, body confidence and posture, as well as increased physical activity levels. The barriers described were generally overcome allowing participants to engage in what was perceived to be a positive and potentially life-changing experience. CONCLUSIONS: A clinical pilates-based exercise programme for people with a parastomal hernia can bring both direct and indirect improvements to a patient's hernia management, sense of wellbeing and day-to-day life. Individuals with a hernia should be informed about the need for, and value of, exercise to strengthen core muscles, as part of their non-surgical options for self-management.

Hernia Active Living Trial (HALT): a feasibility study of a physical activity intervention for people with a bowel stoma who have a parastomal hernia/bulge.

BACKGROUND: Parastomal bulging/hernia is a common complication associated with a stoma. Strengthening of the abdominal muscles via exercise may be a useful self-management strategy. The aim of this feasibility work was to address uncertainties around testing a Pilates-based exercise intervention for people with parastomal bulging. METHODS: An exercise intervention was developed and tested in a single-arm trial (n = 17 recruited via social media) followed by a feasibility randomised controlled trial RCT (n = 19 recruited from hospitals). Adults with an ileostomy or colostomy with a bulge or diagnosed hernia around their stoma were eligible. The intervention involved a booklet, videos, and up to 12 online sessions with an exercise specialist. Feasibility outcomes included intervention acceptability, fidelity, adherence, and retention. Acceptability of self-report measures for quality of life, self-efficacy, and physical activity were assessed based on missing data within surveys pre- and post-intervention. Interviews (n = 12) explored participants' qualitative experiences of the intervention. RESULTS: Nineteen of 28 participants referred to the intervention completed the programme (67%) and received an average of 8 sessions, lasting a mean of 48 min. Sixteen participants completed follow-up measures (44% retention), with low levels of missing data across the different measures, apart from body image and work/social function quality of life subscales (50% and 56% missing, respectively). Themes from qualitative interviews related to the benefits of being involved, including behavioural and physical changes in addition to improved mental health. Identified barriers included time constraints and health issues. CONCLUSIONS: The exercise intervention was feasible to deliver, acceptable to participants, and potentially helpful. Qualitative data suggests physical and psycholosical benefits. Strategies to improve retention need to be included in a future study. TRIAL REGISTRATION: ISRCTN, ISRCTN15207595 . Registered on 11 July 2019.

Quality of life profiles and their association with clinical and demographic characteristics and physical activity in people with a stoma: a latent profile analysis.

PURPOSE: Quality of life can be negatively impacted by the formation of a stoma and is influenced by a number of factors. Research to date treats people with a stoma as a homogenous group based on their quality of life. We attempted to identify subgroups based upon self-reported quality of life and explored variables associated with group membership. METHODS: The present study is a secondary analysis of a cross-sectional sample of 1419 people with a stoma. Participants completed validated questionnaires for quality of life, physical activity and clinical and demographic characteristics. Latent profile analysis was used to identify the optimal number of subgroups (profiles) and multinomial regression modelling was conducted to identify variables associated with profile membership. RESULTS: The analysis revealed 4 distinct profiles of people with a stoma: 'consistently good quality of life' [N = 891 (62.8%)], 'some quality of life concerns' [N = 184 (13.0%)], 'low quality of life' [N = 181 (12.8%)] and 'financial concerns' [N = 163 (11.5%)]. Modelling revealed that people with a recent stoma (formed < 2 years previously), who have a hernia and are less physically active were more likely to belong to the 'low quality of life' profile. Furthermore, those aged 16-55 were more likely to have financial concerns. CONCLUSION: This study was the first to identify latent profiles within this population and assess whether certain variables are associated with membership. Future research should build upon this to identify additional variables associated with these profiles, which can help to provide the basis for targeting and tailoring future interventions to specific subgroups of people with a stoma.

A systematic review and meta-analysis of the effectiveness of self-management interventions in people with a stoma.

AIMS: Explore the evidence from randomized controlled trials for the effect of self-management interventions on quality of life, self-management skills and self-efficacy, and to explore which intervention characteristics are associated with effectiveness. DESIGN: Systematic review. DATA SOURCES: A search of the literature was conducted in these databases: MEDLINE (OVID), EMBASE (OVID) and PsychINFO (OVID) from January 2000 to February 2020. REVIEW METHODS: Studies were included if participants had a bowel stoma, were over the age of 18 and the design was a randomized controlled trial of a self-management programme. The outcome measures for this review were quality of life, self-management skills and self-efficacy. The Behaviour Change Technique Taxonomy was used to code interventions for underlying components and alongside other intervention characteristics, associations with improvements in outcomes were explored. RESULTS: The search identified 3141 articles, 16 of which were eligible. A meta-analysis of self-efficacy scores from five studies (N = 536) found an improvement in those that received the self-management intervention at follow-up with a 12-point mean difference compared with the usual care group. Effects on quality of life and self-management skills were mixed, and meta-analyses of these data were not possible. Across 13 studies an average of 10 behaviour change techniques were used with, credible source (e.g. nurse, doctor, therapist) (n = 13), instruction on how to perform the behaviour (n = 13), demonstration of the behaviour (n = 12) used most often. The behaviour change technique of self-monitoring was associated with an improvement in quality of life. The involvement of a nurse was associated with higher self-efficacy and self-management skills. CONCLUSION: This review suggests that self-management interventions can increase peoples' self-efficacy for managing their stoma. IMPACT: A standardized approach to the reporting of interventions and the measures used is needed in future studies to better understand the effect on quality of life and self-management skills.

HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia.

BACKGROUND: Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL). METHODS: Subjects and sampleThere were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training.Study designThis is a feasibility study of a randomised controlled trial with 2 months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed.InterventionA theoretically informed physical activity intervention was done, targeting people with PSH.Main outcome of feasibility studyThe main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention.Other outcomesWe will evaluate 4 intervention parameters-fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients' consent rate, acceptability of study design and data availability rates for following endpoints): I.Diagnosis and classification of PSHII.Muscle activationIII.Body composition (BMI, waist circumference)IV.Patient reported outcomes: QoL, body image and physical functioningV.Physical activity;VI.Psychological determinants of physical activityOther dataIncluded are other data such as interviews with all participants about the intervention and trial procedures.Data analysis and statistical powerAs this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically. DISCUSSION: The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression. TRIAL REGISTRATION: ISRCTN15207595.

A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study.

BACKGROUND: We hypothesise that a physical activity (PA) intervention will improve the quality of life (QoL) of people with a stoma. A feasibility study of the intervention and trial parameters is necessary to inform a future main trial. METHODS: Participants received a weekly PA consultation by telephone, video conferencing, or face-to-face for 12 weeks with a PA instructor who prescribed physical activities and supported participants by addressing stoma-related concerns and using behaviour change techniques. A feasibility study of the intervention and trial parameters was conducted in three UK sites using mixed methods. RESULTS: The number of eligible patients consenting to the study was 30 out of 174 (17%). Most participants were female (73%); 73% had an ileostomy and 27% a colostomy; mean time since diagnosis was 6 months. A total of 18 (64%) participants completed pre- (baseline) and post-intervention (follow-up) measures. Results show an improvement on all scales measuring QoL and disease-specific fatigue. The median PA consultation rate per participant was eight sessions. Participants reported completing 75% or more of the prescribed PA each week. Eight stoma-related themes were identified from qualitative interviews: fear of hernia, bending down, fatigue, pain, prolapse, surgical wounds, stoma appliance, and stigma. The intervention appeared to address these issues. CONCLUSION: This feasibility study demonstrated that a novel manualised PA intervention for people with a stoma is safe, feasible, and acceptable, and shows promise for improving outcomes. However, difficulties with recruitment will need to be carefully considered to ensure the success of future studies in this area. TRIAL REGISTRATION: ISCTN, ISRCTN58613962; Registered 14/9/2017.

Experiences of wearing support garments by people living with a urostomy.

BACKGROUND: support garments are commonly worn by people with a urostomy but there are no published data about their experiences of doing so. AIMS: to identify the views of people living with a urostomy on the role of support garments. METHODS: a cross-sectional survey of the stoma population's experiences of support garments was conducted in 2018. Recruitment was by social media. The free-text responses provided by a sub-sample of 58 people out of 103 respondents with a urostomy, were analysed. FINDINGS: thematic analysis revealed four themes: physical self-management; psychosocial self-management; lifestyle; and healthcare advice and support. There were mixed feelings about the value of support garments. Many cited a sense of reassurance and confidence and being able to be more sociable and active; others reported discomfort and uncertainty about their value. CONCLUSION: these findings add new understanding of experiences of support garments and provide novel theoretical insights about life with a urostomy.

Experiences of support garments following bowel stoma formation: analysis of free-text responses in a cross-sectional survey.

AIM: To explore the experiences of support garments when adjusting to bodily change following bowel stoma formation. DESIGN: Thematic analyses of free-text responses in a cross-sectional survey of the stoma population in 2018. METHODS: Free-text responses were invited so that respondents could describe their experiences in more detail. A process of induction was chosen to allow for themes to emerge directly from the data. The concept 'embodiment' was used as a theoretical framework during interpretation. RESULTS: 1425 people with a bowel stoma responded to the survey, of whom 598 provided free-text responses. Four themes about experiences of support garments in the context of changed bodily experiences following stoma formation were identified: body complications, which is about experiences of using support garments to prevent or self-manage parastomal hernia; body appearance, which is about hiding the stoma and stoma appliance; body function, which is about managing stoma appliance complications; and body sensation, which is mainly about negative experiences of ill-fitting garments. CONCLUSION: Support garments can be understood as items that are used by people during an ongoing process of adjusting to bodily changes following stoma formation and as part of an ongoing process of reconstructing new embodied selves. IMPACT: This is the first study to explore people's experiences of support garments following bowel stoma formation. Support garments are used in the self-management of body complications, appearance, function and sensations. Stoma nurses may draw on the findings of this study to advise patients about the benefits of garments for adjusting to bodily change, and garment suppliers should address people's negative experiences by improving garments.

A physical activity intervention to improve the quality of life of patients with a stoma: a feasibility study protocol.

BACKGROUND: Physical activity (PA) is positively associated with quality of life. People with a stoma are less likely to engage in PA than those without a stoma. METHODS: In this feasibility intervention study, we will perform the following: (1) Develop a PA intervention for people with a stoma. An Expert Working Group of behavioural scientists, exercise scientists, clinicians and a Patient Advisory Group of people with a bowel stoma will meet with the research team to inform the development of a PA intervention for people with a stoma. A manual of the intervention will be the main output. (2) Explore PA instructors' experiences of delivering the PA intervention. PA instructors will record on paper the number of PA consultations with each patient and a researcher will interview the PA instructors about their experiences of delivering the intervention. (3) Assess the level of patient (bowel cancer or inflammatory bowel disease (IBD) patients with a stoma between 6 weeks and 24 months post-surgery) engagement with the PA intervention and their views on intervention acceptability and usefulness. Patients will keep a PA diary to record daily pedometer recorded step count and type and duration of activities. A researcher will interview patients about their experiences of the PA intervention. (4) Assess screening, eligibility, consent, data completion, loss to follow up, and missing data rates, representativeness of participants and potential treatment effects. A researcher will record on paper all study procedure parameters. Quality of life (stoma-quality of life; Functional Assessment of Cancer Therapy, Short IBD questionnaire), fatigue (FACIT fatigue scale) and PA (accelerometer) will be measured pre- and post-intervention in patients. For IBD patients only, blood will be taken to measure systemic inflammation. DISCUSSION: We hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma. Before embarking on a full randomised controlled trial to test this hypothesis, a PA intervention needs to be developed and a feasibility study of the proposed PA intervention conducted. TRIAL REGISTRATION: ISRCTN58613962, Protocol version: 0.1. 14 September 2017.

Physical activity referral to cardiac rehabilitation, leisure centre or telephone-delivered consultations in post-surgical people with breast cancer: a mixed methods process evaluation.

BACKGROUND: Physical activity (PA) programmes effective under 'research' conditions may not be effective under 'real-world' conditions. A potential solution is to refer patients to existing PA community-based PA services. METHODS: A process evaluation of referral of post-surgical patients with early-stage breast cancer to cardiac rehabilitation exercise classes, leisure centre with 3-month free leisure centre membership or telephone-delivered PA consultations for 12 weeks. Quantitative data were collected about PA programme uptake and reach, patient engagement with the PA programme, delivery and fidelity and PA dose. Qualitative data were collected about patient experiences of taking part in the PA programmes. Audio-recorded qualitative interviews of participants about the programmes were analysed thematically. Quantitative data were reported descriptively using means and SD. RESULTS: In Phase I, 30% (n = 20) of eligible patients (n = 20) consented, 85% (n = 17) chose referral to leisure centre, and 15% (n = 3) chose cardiac rehabilitation. In Phase II, 32% (n = 12) consented, 25% (n = 3) chose leisure centre and 75% (n = 9) chose telephone-delivered PA consultations. Walking at light intensity for about an hour was the most common PA. All Phase I participants received an induction by a cardiac rehabilitation physiotherapist or PA specialist from the leisure centre but only 50% of Phase II participants received an induction by a PA specialist from the leisure centre. Four themes were identified from qualitative interviews about programme choice: concerns about physical appearance, travel distance, willingness to socialise and flexibility in relation to doing PA. Four themes were identified about facilitators and barriers for engaging in PA: feeling better, feeling ill, weight management, family and friends. CONCLUSIONS: The current community-based PA intervention is not yet suitable for a definitive effectiveness randomised controlled trial. Further work is needed to optimise PR programme reach, PA dose and intervention fidelity. TRIAL REGISTRATION: ISRCTN11183372.

The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study.

BACKGROUND: Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials' protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design. METHODS: A pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients' and clinicians' perceptions and experiences of the main trial procedures were explored by interview. RESULTS: Quantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation. Qualitative study: Thirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation. CONCLUSIONS: The study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials. TRIAL REGISTRATION: ISRCTN63510637.

Is referral of postsurgical colorectal cancer survivors to cardiac rehabilitation feasible and acceptable? A pragmatic pilot randomised controlled trial with embedded qualitative study.

OBJECTIVES: (1) Assess whether cardiac rehabilitation (CR) is a feasible and acceptable model of rehabilitation for postsurgical colorectal cancer (CRC) survivors, (2) evaluate trial procedures. This article reports the results of the first objective. DESIGN AND SETTING: A pragmatic pilot randomised controlled trial with embedded qualitative study was conducted in 3 UK hospitals with CR facilities. Descriptive statistics were used to summarise trial parameters indicative of intervention feasibility and acceptability. Interviews and focus groups were conducted and data analysed thematically. PARTICIPANTS: People with CRC were considered for inclusion in the trial if they were ≥ 18 years old, diagnosed with primary CRC and in the recovery period postsurgery (they could still be receiving adjuvant therapy). 31% (n=41) of all eligible CRC survivors consented to participate in the trial. 22 of these CRC survivors, and 8 people with cardiovascular disease (CVD), 5 CRC nurses and 6 CR clinicians participated in the qualitative study. INTERVENTION: Referral of postsurgical CRC survivors to weekly CR exercise classes and information sessions. Classes included CRC survivors and people with CVD. CR nurses and physiotherapists were given training about cancer and exercise. RESULTS: Barriers to CR were protracted recoveries from surgery, ongoing treatments and poor mobility. No adverse events were reported during the trial, suggesting that CR is safe. 62% of participants completed the intervention as per protocol and had high levels of attendance. 20 health professionals attended the cancer and exercise training course, rating it as excellent. Participants perceived that CR increased CRC survivors' confidence and motivation to exercise, and offered peer support. CR professionals were concerned about CR capacity to accommodate cancer survivors and their ability to provide psychosocial support to this group of patients. CONCLUSIONS: CR is feasible and acceptable for postsurgical CRC survivors. A large-scale effectiveness trial of the intervention should be conducted. TRIAL REGISTRATION NUMBER: ISRCTN63510637.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

BACKGROUND: Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. METHODS: Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. RESULTS: There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. CONCLUSIONS: Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required. TRIAL REGISTRATION: ISRCTN63510637; UKCRN id 14092.

CRIB--the use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial (RCT) with embedded feasibility study.

INTRODUCTION: Patients with colorectal cancer report ongoing physical and psychological impairments and a high proportion of these patients are overweight, insufficiently active and high-risk drinkers, putting them at risk of poor recovery and risk of recurrence and comorbidities. A challenge is implementing sustainable and effective rehabilitation as part of routine care for this group. METHODS AND ANALYSIS: A two-arm pilot randomised controlled trial (RCT) with embedded feasibility study undertaken as a phased programme of work. The intervention involves an existing cardiac rehabilitation programme for cardiac patients accepting colorectal cancer patient referrals. The intervention consists of supervised exercise sessions run by a cardiac physiotherapist and information sessions. Phase 1 will involve one research site enrolling 12 patients to assess intervention and study design processes. Semistructured interviews with patients with colorectal cancer and cardiac patients and clinicians will be used to gather data on acceptability of the intervention and study procedures. Phase 2 will involve three sites enrolling 66 patients with colorectal cancer randomised to control or intervention groups. Outcome measures will be taken preintervention and postintervention, for phases 1 and 2. The primary outcome is accelerometer measured physical activity; secondary outcomes are self-report physical activity, quality of life, anxiety, depression, symptoms including fatigue. The following variables will also be examined to determine if these factors influence adherence and outcomes: self-efficacy, risk perception and treatments. ETHICS AND DISSEMINATION: Full ethical approval was granted by NRES Committees-North of Scotland (13/NS/0004; IRAS project ID: 121757) on 22 February 2013. The proposed work is novel in that it aims to test the feasibility and acceptability of using an evidence-based and theory driven existing cardiac rehabilitation service with patients with colorectal cancer. Should this model of rehabilitation prove to be clinically and cost effective we aim to conduct a randomised controlled trial of this intervention to measure effectiveness. TRIAL REGISTRATION REFERENCE: ISRCTN63510637; UKCRN id 14092.

Patient focused Internet-based approaches to cardiovascular rehabilitation--a systematic review.

Cardiac rehabilitation (CR) has been shown to improve health behaviours and risk factors and the evidence suggests that home CR is as effective as hospital-based CR. Telemedicine offers the potential for more patients to engage in CR. We reviewed the evidence for patient focused Internet-based approaches to cardiovascular rehabilitation. Searches were performed in PubMed, EMBASE, Scopus and the Cochrane Controlled Trials Register. In total, nine studies involving 830 patients with heart disease that compared Internet-based cardiac rehabilitation to usual care were identified. The quality of trials was assessed using the Jadad scale. Outcome data were pooled under four subheadings: compliance; physical activity outcomes; clinical outcomes; psychosocial outcomes. Compliance rates were high but dropped over time in all studies. Physical activity measures were generally improved, as were clinical outcomes. Changes in psychosocial measures were positive, with two studies noting no change. No interventions noted a negative effect on outcomes. Despite the relatively small number of trials and the limited outcome measures, the results appeared to be positive with regard to patient outcomes and patient feedback. However, none had progressed to a clinical service.