A mixed methods feasibility study of nicotine-assisted smoking reduction programmes delivered by community pharmacists - The RedPharm study.

BACKGROUND: Pivotal trials have established that, among people who have no immediate intention to quit smoking, nicotine replacement therapy (NRT) helps people reduce and eventually stop smoking. The prime aim of this trial was to investigate the feasibility of implementing such a programme in community pharmacies. In addition, we investigated the effectiveness of providing behavioural support compared with self-help methods and of shorter compared with standard length reduction programmes. METHODS: Pharmacists were trained to deliver a smoking reduction programme and opportunistically invite people to participate in the programme. In a 2 × 2 factorial design, eligible volunteers were randomised to either receive in-person behavioural support or a self-help booklet. In both cases, participants were supported to set targets to reduce their smoking and use behavioural techniques to assist reduction. In addition, participants were randomised to cut down and stop over 4 weeks or over 16 weeks, but in either case continue NRT for up to nine months. We assessed uptake and adherence to the programme and smoking cessation four weeks and six months after a quit day and reduction in the three months following programme end and incorporated a qualitative processes assessment. RESULTS: Only 68 of the planned 160 smokers could be recruited. Pharmacists were deterred by the bureaucracy of trial enrolment and that many smokers did not return for further support. Pharmacists sometimes subverted the randomisation or provided support to participants in the self-help arm. Smokers stayed in the programme for an average of 6 weeks rather than the 9 months envisaged. Rates of follow-up declined to around 20% of participants by 12 months. There was insufficient evidence to assess whether support or speed of reduction enhanced cessation or reduction but cessation and reduction were less common overall than in the pivotal trials for licensing NRT for this indication. CONCLUSIONS: This programme of smoking reduction and the trial design to assess its effectiveness proved unpopular to potential participants and pharmacists. As a result, the trial produced no evidence on the effectiveness of behavioural support or speed or smoking reduction. A trial of this programme in this context is unfeasible. TRIAL REGISTRATION: ISRCTN 54805841 . Registered 18 March 2010.

A randomised trial of nicotine assisted reduction to stop in pharmacies - the RedPharm study.

BACKGROUND: Public policy and clinical treatment in tobacco addiction in the UK has focused on cessation: an abrupt attempt to stop all cigarettes. However, recent evidence suggests that allowing more gradual withdrawal from tobacco or even permanent partial substitution by nicotine replacement therapy (NRT) could lead to net benefits to public health. No jurisdiction has introduced smoking reduction programmes in normal clinical care and the best methods for their implementation is uncertain. Community pharmacists offering smoking cessation services in the UK are ideally placed to implement reduction programmes.This pilot study aims therefore to examine the feasibility of implementing smoking reduction programme in pharmacies, and also to see if behavioural support and a longer treatment affect the success rate for cessation. DESIGN AND METHODS: This is a 2 × 2 randomised factorial trial of behavioural support versus no support and short versus standard length reduction programme. The pharmacists will recruit 16 patients per pharmacy, 160 smokers altogether. Pharmacists will randomise each participant by sealed envelopes. In a standard supported programme, the pharmacist will give support for 34 weeks, inviting participants to set a treatment goal and providing advice on how to reduce cigarette use. Participants in the short programme will be given the same advice on how to reduce but will reduce smoking over four weeks. Participants in the no support arms will be given a leaflet that describes the reduction programmes in 4-week and 34-week format. All participants are encouraged to use of NRT to support the reduction. These processes will be measured by recording the number of recruited smokers; percentage of those who reduce and sustain their consumption to at least 50% of baseline value, and the proportion of people who attain 4 weeks abstinence and 6 months abstinence. Interviews will assess smokers' and pharmacists' views on the way the programme ran. DISCUSSION: This is a pilot study to assess the feasibility of offering smoking reduction programme within pharmacies that offer naturalistic setting to show population benefit from these programmes. Findings from this trial will inform the development of evidence-based treatment for smokers who want to reduce and best approaches to engage reluctant quitters onto the programme. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 2010-019259-24.

Interventions to enhance return-to-work for cancer patients.

BACKGROUND: Cancer survivors are 1.4 times more likely to be unemployed than healthy people. It is therefore important to provide cancer patients with programmes to support the return-to-work process. OBJECTIVES: To evaluate the effectiveness of interventions aimed at enhancing return-to-work in cancer patients. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in The Cochrane Library Issue 2, 2010), MEDLINE, EMBASE, CINAHL, OSH-ROM, PsycINFO, DARE, ClinicalTrials.gov, Trialregister.nl and Controlled-trials.com to February 2010, reference lists of included articles and selected reviews, and contacted authors of relevant articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) and controlled before-after studies (CBAs) of the effectiveness of psychological, vocational, physical, medical or multidisciplinary interventions enhancing return-to-work in cancer patients. The primary outcome was return-to-work measured as either return-to-work rate or sick leave duration. Secondary outcome was quality of life. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed the risk of bias and extracted data. We pooled studies with sufficient data, judged to be clinically homogeneous in different comparisons. We assessed the overall quality of the evidence for each comparison using the GRADE approach. MAIN RESULTS: Fourteen articles reporting 14 RCTs and 4 CBAs were included. These studies involved a total of 1652 participants. Results indicated low quality evidence of similar return-to-work rates for psychological interventions compared to care as usual (odds ratio (OR) = 2.32, 95% confidence interval (CI) 0.94 to 5.71). No vocational interventions were retrieved. Very low evidence suggested that physical training was not more effective than care as usual on improving return-to-work (OR = 1.20, 95% CI 0.32 to 4.54). Eight RCTs on medical interventions showed low quality evidence that functioning conserving approaches had similar return-to-work rates as more radical treatments (OR = 1.53, 95% CI 0.95 to 2.45). Moderate quality evidence showed multidisciplinary interventions involving physical, psychological and vocational components led to higher return-to-work rates than care as usual (OR = 1.87, 95% CI 1.07 to 3.27). No differences in the effect of psychological, physical, medical or multidisciplinary interventions compared to care as usual were found on quality of life outcomes. AUTHORS' CONCLUSIONS: Moderate quality evidence showed that employed patients with cancer experience return-to-work benefits from multidisciplinary interventions compared to care as usual. More high quality RCTs aimed at enhancing return-to-work in cancer patients are needed.

Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial.

BACKGROUND: Compared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large. Therefore, return-to-work of cancer patients needs to be improved by way of an intervention. The objective is to describe the development and content of a work-directed intervention to enhance return-to-work in cancer patients and to explain the study design used for evaluating the effectiveness of the intervention. DEVELOPMENT AND CONTENT OF THE INTERVENTION: The work-directed intervention has been developed based on a systematic literature review of work-directed interventions for cancer patients, factors reported by cancer survivors as helping or hindering their return-to-work, focus group and interview data for cancer patients, health care professionals, and supervisors, and vocational rehabilitation literature. The work-directed intervention consists of: 1) 4 meetings with a nurse at the treating hospital department to start early vocational rehabilitation, 2) 1 meeting with the participant, occupational physician, and supervisor to make a return-to-work plan, and 3) letters from the treating physician to the occupational physician to enhance communication. STUDY DESIGN TO EVALUATE THE INTERVENTION: The treating physician or nurse recruits patients before the start of initial treatment. Patients are eligible when they have a primary diagnosis of cancer, will be treated with curative intent, are employed at the time of diagnosis, are on sick leave, and are between 18 and 60 years old. After the patients have given informed consent and have filled out a baseline questionnaire, they are randomised to either the control group or to the intervention group and receive either care as usual or the work-directed intervention, respectively. Primary outcomes are return-to-work and quality of life. The feasibility of the intervention and direct and indirect costs will be determined. Outcomes will be assessed by a questionnaire at baseline and at 6, 12, 18, and 24 months after baseline. DISCUSSION: This study will provide information about the effectiveness of a work-directed intervention for cancer patients. The intention is to implement the intervention in normal care if it has been shown effective. TRIAL REGISTRATION: NTR1658.

Strategies to improve recruitment to randomised controlled trials.

BACKGROUND: Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. OBJECTIVES: To quantify the effects of strategies to improve recruitment of participants to randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Methodology Review Group Specialised Register - CMR (The Cochrane Library (online) Issue 1 2008) (searched 20 February 2008); MEDLINE, Ovid (1950 to date of search) (searched 06 May 2008); EMBASE, Ovid (1980 to date of search) (searched 16 May 2008); ERIC, CSA (1966 to date of search) (searched 19 March 2008); Science Citation Index Expanded, ISI Web of Science (1975 to date of search) (searched 19 March 2008); Social Sciences Citation Index, ISI Web of Science (1975 to date of search) (searched 19 March 2008); and National Research Register (online) (Issue 3 2007) (searched 03 September 2007); C2-SPECTR (searched 09 April 2008). We also searched PubMed (25 March 2008) to retrieve "related articles" for 15 studies included in a previous version of this review. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of methods to increase recruitment to randomised controlled trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. Studies aiming to increase response rates to questionnaires or trial retention, or which evaluated incentives and disincentives for clinicians to recruit patients were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted on the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used risk ratios and their 95% confidence intervals to describe the effects in individual trials, and assessed heterogeneity of these ratios between trials. MAIN RESULTS: We identified 27 eligible trials with more than 26,604 participants. There were 24 studies involving interventions aimed directly at trial participants, while three evaluated interventions aimed at people recruiting participants. All studies were in health care. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (RR 2.66, 95% CI 1.37 to 5.18), use of opt-out, rather than opt-in, procedures for contacting potential trial participants (RR 1.39, 95% CI 1.06 to 1.84) and open designs where participants know which treatment they are receiving in the trial (RR 1.25, 95% CI 1.18 to 1.34). However, some of these strategies have disadvantages, which may limit their widespread use. For example, opt-out procedures are controversial and open designs are by definition unblinded. The effects of many other recruitment strategies are unclear; examples include the use of video to provide trial information to potential participants and modifying the training of recruiters. Many studies looked at recruitment to hypothetical trials and it is unclear how applicable these results are to real trials. AUTHORS' CONCLUSIONS: Trialists can increase recruitment to their trials by using the strategies shown to be effective in this review: telephone reminders; use of opt-out, rather than opt-in; procedures for contacting potential trial participants and open designs. Some strategies (e.g. open trial designs) need to be considered carefully before use because they also have disadvantages. For example, opt-out procedures are controversial and open designs are by definition unblinded.

Strategies to improve recruitment to randomised controlled trials.

BACKGROUND: Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. OBJECTIVES: To quantify the effects of strategies to improve recruitment of participants to randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Methodology Review Group Specialised Register - CMR (The Cochrane Library (online) Issue 1 2008) (searched 20 February 2008); MEDLINE, Ovid (1950 to date of search) (searched 06 May 2008); EMBASE, Ovid (1980 to date of search) (searched 16 May 2008); ERIC, CSA (1966 to date of search) (searched 19 March 2008); Science Citation Index Expanded, ISI Web of Science (1975 to date of search) (searched 19 March 2008); Social Sciences Citation Index, ISI Web of Science (1975 to date of search) (searched 19 March 2008); and National Research Register (online) (Issue 3 2007) (searched 03 September 2007); C2-SPECTR (searched 09 April 2008). We also searched PubMed (25 March 2008) to retrieve "related articles" for 15 studies included in a previous version of this review. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of methods to increase recruitment to randomised controlled trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. Studies aiming to increase response rates to questionnaires or trial retention, or which evaluated incentives and disincentives for clinicians to recruit patients were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted on the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used risk ratios and their 95% confidence intervals to describe the effects in individual trials, and assessed heterogeneity of these ratios between trials. MAIN RESULTS: We identified 27 eligible trials with more than 26,604 participants. There were 24 studies involving interventions aimed directly at trial participants, while three evaluated interventions aimed at people recruiting participants. All studies were in health care. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (RR 2.66, 95% CI 1.37 to 5.18), use of opt-out, rather than opt-in, procedures for contacting potential trial participants (RR 1.39, 95% CI 1.06 to 1.84) and open designs where participants know which treatment they are receiving in the trial (RR 1.25, 95% CI 1.18 to 1.34). However, some of these strategies have disadvantages, which may limit their widespread use. For example, opt-out procedures are controversial and open designs are by definition unblinded. The effects of many other recruitment strategies are unclear; examples include the use of video to provide trial information to potential participants and modifying the training of recruiters. Many studies looked at recruitment to hypothetical trials and it is unclear how applicable these results are to real trials. AUTHORS' CONCLUSIONS: Trialists can increase recruitment to their trials by using the strategies shown to be effective in this review: telephone reminders; use of opt-out, rather than opt-in; procedures for contacting potential trial participants and open designs. Some strategies (e.g. open trial designs) need to be considered carefully before use because they also have disadvantages. For example, opt-out procedures are controversial and open designs are by definition unblinded.

Establishing the added benefit of measuring MMP9 in FOB positive patients as a part of the Wolverhampton colorectal cancer screening programme.

BACKGROUND: Bowel cancer is common and a major cause of death. The NHS is currently rolling out a national bowel cancer screening programme that aims to cover the entire population by 2010. The programme will be based on the Faecal Occult Blood test (FOBt) that reduces mortality from colon cancer by 16%. However, FOB testing has a relatively low positive predictive value, with associated unnecessary cost, risk and anxiety from subsequent investigation, and is unacceptable to a proportion of the target population. Increased levels of an enzyme called matrix metalloproteinase 9 (MMP9) have been found to be associated with colorectal cancer, and this can be measured from a blood sample. MMP9 has potential for detecting those at risk of having colorectal cancer. The aim of this study is to assess whether MMP9 estimation enhances the predictive value of a positive FOBt. METHODS AND DESIGN: FOBt positive people aged 60-69 years attending the Wolverhampton NHS Bowel Cancer Screening Unit and providing consent for colonoscopy will be recruited. Participants will provide a blood sample prior to colonoscopy and permission for collection of the clinical outcome from screening unit records. Multivariate logistic regression analyses will determine the independent factors (patient and disease related, MMP9) associated with the prediction of neoplasia. DISCUSSION: Colorectal cancer is a major cause of morbidity and mortality. Pilot studies have confirmed the feasibility of the national cancer screening programme that is based on FOBt. However, the test has high false positive rates. MMP9 has significant potential as a marker for both adenomas and cancers. This study is to examine whether using MMP9 as an adjunct to FOBt improves the accuracy of screening and reduces the number of false positive tests that cause anxiety and require invasive and potentially harmful investigation.

Cancer survivors and unemployment: a meta-analysis and meta-regression.

CONTEXT: Nearly half of adult cancer survivors are younger than 65 years, but the association of cancer survivorship with employment status is unknown. OBJECTIVE: To assess the association of cancer survivorship with unemployment compared with healthy controls. DATA SOURCES: A systematic search of studies published between 1966 and June 2008 was conducted using MEDLINE, CINAHL, EMBASE, PsycINFO, and OSH-ROM databases. STUDY SELECTION: Eligible studies included adult cancer survivors and a control group, and employment as an outcome. DATA EXTRACTION: Pooled relative risks were calculated over all studies and according to cancer type. A Bayesian meta-regression analysis was performed to assess associations of unemployment with cancer type, country of origin, average age at diagnosis, and background unemployment rate. RESULTS: Twenty-six articles describing 36 studies met the inclusion criteria. The analyses included 20,366 cancer survivors and 157,603 healthy control participants. Studies included 16 from the United States, 15 from Europe, and 5 from other countries. Overall, cancer survivors were more likely to be unemployed than healthy control participants (33.8% vs 15.2%; pooled relative risk [RR], 1.37; 95% confidence interval [CI], 1.21-1.55). Unemployment was higher in breast cancer survivors compared with control participants (35.6% vs 31.7%; pooled RR, 1.28; 95% CI, 1.11-1.49), as well as in survivors of gastrointestinal cancers (48.8% vs 33.4%; pooled RR, 1.44; 95% CI, 1.02-2.05), and cancers of the female reproductive organs (49.1% vs 38.3%; pooled RR, 1.28; 95% CI, 1.17-1.40). Unemployment rates were not higher for survivors of blood cancers compared with controls (30.6% vs 23.7%; pooled RR, 1.41; 95% CI, 0.95-2.09), prostate cancers (39.4% vs 27.1%; pooled RR, 1.11; 95% CI, 1.00-1.25), or testicular cancer (18.5% vs 18.1%; pooled RR, 0.94; 95% CI, 0.74-1.20). For survivors in the United States, the unemployment risk was 1.5 times higher compared with survivors in Europe (meta-RR, 1.48; 95% credibility interval, 1.15-1.95). After adjustment for diagnosis, age, and background unemployment rate, this risk disappeared (meta-RR, 1.24; 95% CI, 0.85-1.83). CONCLUSION: Cancer survivorship is associated with unemployment.

Comparative study of work ability between cancer survivors and their referents.

Even though cancer survivors are often able to continue working after they have been diagnosed, they may have health impairments resulting in reduced work ability. We studied the current work ability of 591 employed people with an early-stage of breast cancer, lymphoma, testicular or prostate cancer, and 757 referents. We also investigated whether the survivors perceived that cancer had impaired their work ability, and which disease-related, socio-demographic and social factors at work had an impact on their work ability. The work ability of the cancer survivors did not differ from that of their referents. Among the survivors, 26% reported that their physical work ability, and 19% that their mental work ability had deteriorated due to cancer. The survivors who had other diseases or had had chemotherapy, most often reported impaired work ability, whereas survivors with a strong commitment to their work organisation, or a good social climate at work, reported impairment less frequently.

The effect of complementary and alternative medicine on the quality of life of cancer survivors: a systematic review and meta-analyses.

PURPOSE: To assess whether quality of life (QOL) improved in cancer survivors who had undertaken a complementary and alternative medicine (CAM) intervention, compared to cancer survivors who had not. METHODS: A systematic review of randomised controlled trials (RCTs) was undertaken. Electronic databases including MEDLINE, Cochrane CENTRAL, CINAHL, PSYCHINFO, EMBASE, and ClinicalTrials.gov were searched from 1990 to 2012. Search terms incorporating the concepts of cancer survivors, QOL and various types of CAM were used. RESULTS: From 1767 records retrieved and screened 13 full text articles were included in the review. Nine studies were deemed to have a high risk, one a low risk, and three an unclear risk of bias. CAM interventions used incorporated yoga, meditation or mindfulness, energy healing, medical qigong, homoeopathy, or mistletoe therapy. Ten of the studies used breast cancer survivors, whilst the remaining three included other cancer types. The studies had mixed results either showing a significantly greater improvement in QOL in the intervention group compared to the control group, or no significant difference between groups. However, twelve studies were of low to moderate quality, limiting the robustness of findings. CONCLUSIONS: This review has identified significant gaps in the evidence base for the effectiveness of CAM on QOL in cancer survivors. Further work in this field needs to adopt more rigorous methodology to help support cancer survivors to actively embrace self-management and effective CAMs, without recommending inappropriate interventions which are of no proven benefit.

Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis.

UNLABELLED: This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. OBJECTIVE: To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. DESIGN: Systematic review. DATA SOURCES: The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. STUDY SELECTION: Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. RESULTS: 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters. CONCLUSIONS: There are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.

Cancer survivors' received and needed social support from their work place and the occupational health services.

GOALS OF WORK: Even though a lot of studies have been conducted concerning cancer patients' social support, the importance of social support from the work life is unclear. We examined the amount of emotional and practical support that cancer survivors needed and had actually received from their coworkers, supervisors, and the occupational health personnel. We also examined whether disease-related or sociodemographic background variables were associated with needed or received support. Finally, we investigated whether there were differences between various sources in received or needed support. PATIENTS AND METHODS: The data consisted of a total of 640 cancer survivors with breast cancer, lymphoma, testicular or prostate cancer, aged 25-57 years at the time of diagnosis. Information on social support was collected with a mailed questionnaire using an adapted version of the Structural-Functional Social Support Scale (SFSS). MAIN RESULTS: The cancer survivors had received most support from their coworkers and they hoped for more support especially from the occupational health care personnel (39% of women and 29% of men). The men who had lymphoma, had received chemotherapy, or had low education level needed more support. The need for practical support from the occupational health personnel was fivefold between the chemotherapy-treated and those not treated. The women both received and needed more support than the men did. CONCLUSIONS: There is a clear need for additional social support from work life among the cancer survivors especially from the occupational health personnel.