Systematic review of the use of translated patient-reported outcome measures in cancer trials.

BACKGROUND: Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition. METHODS: Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs. RESULTS: Eighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified. CONCLUSIONS: Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

Predictors of progression free survival, overall survival and early cessation of chemotherapy in women with potentially platinum sensitive (PPS) recurrent ovarian cancer (ROC) starting third or subsequent line(≥3) chemotherapy - The GCIG symptom benefit study (SBS).

BACKGROUND: Potentially platinum sensitive recurrent ovarian cancer (PPS ROC) is defined by a platinum-free interval of >6 months, and usually treated with platinum-based chemotherapy with variable response and benefit in women who have had 3 or more lines of chemotherapy(≥3). We identified baseline characteristics (health-related quality of life[HRQL] and clinicopathological factors), associated with PFS, OS and early progression (within 8 weeks). The goal is to improve patient selection for chemotherapy based on a nomogram predicting PFS. METHODS: HRQL was assessed with EORTC QLQ-C30/QLQ-OV28. Associations with PFS and OS were assessed with Cox proportional hazards regression. Variables significant in univariable analysis were included in multivariable analyses using backward elimination to select those significant. Associations with stopping chemotherapy early were assessed with logistic regression. RESULTS: 378 women were enrolled, with median(m)OS and PFS of 16.6 months and 5.3 months, respectively. The majority had ECOGPS 0-1. Chemotherapy was stopped early in 45/378 participants (12%); with mOS 3.4 months (95% CI: 1.7-7.2). Physical function(PF), role function(RF), cognitive function(CF), social function(SF), Global Health Status(GHS) and abdominal/GI symptoms(AGIS) were significant univariable predictors of PFS(p < 0.030). SF remained significant after adjusting for clinicopathological factors; p = 0.03. PF, RF, CF, SF, GHS and AGIS were significant univariable predictors of OS (p < 0.007); PF, RF, SF and GHS remained significant predictors of OS in multivariable models; p < 0.007. Poor baseline PF and GHS were significant univariable predictors of stopping chemotherapy early (p < 0.007) but neither remained significant after adjusting for clinicopathological factors. CONCLUSION: Baseline HRQL is simple to measure, is predictive of PFS and OS and when used in conjunction with clinicopathological prognostic factors, can assist with clinical decision making and treatment recommendations for women with PPSROC≥3.

Prevalence and predictors of complementary and alternative medicine/non-pharmacological interventions use for menopausal symptoms within the UK Collaborative Trial of Ovarian Cancer Screening.

OBJECTIVES: The negative publicity about menopausal hormone therapy (MHT) has led to increased use of complementary and alternative medicines (CAM) and non-pharmacological interventions (NPI) for menopausal symptom relief. We report on the prevalence and predictors of CAM/NPI among UK postmenopausal women. METHOD: Postmenopausal women aged 50-74 years were invited to participate in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). A total of 202 638 women were recruited and completed a baseline questionnaire. Of these, 136 020 were sent a postal follow-up-questionnaire between September 2006 and May 2009 which included ever-use of CAM/NPI for menopausal symptom relief. Both questionnaires included MHT use. RESULTS: A total of 88 430 (65.0%) women returned a completed follow-up-questionnaire; 22 206 (25.1%) reported ever-use of one or more CAM/NPI. Highest use was reported for herbal therapies (43.8%; 9725/22 206), vitamins (42.6%; 9458/22 206), lifestyle approaches (32.1%; 7137/22 206) and phytoestrogens (21.6%; 4802/22 206). Older women reported less ever-use of herbal therapies, vitamins and phytoestrogens. Lifestyle approaches, aromatherapy/reflexology/acupuncture and homeopathy were similar across age groups. Higher education, Black ethnicity, MHT or previous oral contraceptive pill use were associated with higher CAM/NPI use. Women assessed as being less hopeful about their future were less likely to use CAM/NPI. CONCLUSION: One in four postmenopausal women reported ever-use of CAM therapies/NPI for menopausal symptom relief, with lower use reported by older women. Higher levels of education and previous MHT use were positive predictors of CAM/NPI use. UKCTOCS Trial registration: ISRCTN22488978.

Attitudes, challenges and needs about diet and physical activity in endometrial cancer survivors: a qualitative study.

With rates of endometrial cancer survival increasing, there is growing interest about lifestyle behaviours that could improve quality of life and reduce the risk for chronic diseases. This study aimed to explore the attitudes, challenges and needs of endometrial cancer survivors regarding diet and physical activity. Sixteen UK-based endometrial cancer survivors participated in two focus groups (n = 5, n = 3) or individual telephone interviews (n = 8), using a semi-structured interview guide. Data were collectively analysed by two researchers until consensus was reached on a coding structure. Data analysis proceeded until themes were identified. Participants were within 5 years post-cancer treatment with median age and BMI of 57 years and 25.8 kg m-2 respectively. Three themes were identified: (1) defining a healthy lifestyle, (2) factors influencing diet and physical activity and (3) needing to search for information. Results suggest interventions should incorporate recommendations on managing late-treatment effects, and behaviour change techniques for cognitive, practical and social barriers to healthy lifestyle changes. Healthcare professionals are in a vital position to provide or introduce endometrial cancer survivors to in-person behaviour change interventions at the early post-treatment period.

Population-based, risk-stratified genetic testing for ovarian cancer risk: a focus group study.

STUDY PURPOSE: A population-based risk stratification programme for ovarian cancer (OC) may improve OC survival by identifying women at increased risk and implementing an appropriate risk management strategy. The present study explored attitudes towards an OC risk stratification programme incorporating predictive genetic testing and risk-stratified screening as part of a larger study investigating OC screening. METHODS: Focus groups consisting of 56 members of the general public (mean age 45 years; 34% non-white) were conducted using a hypothetical scenario. The group sessions were recorded, transcribed verbatim and analysed using Framework Analysis. RESULTS: There was strong support for the proposed programme. Genetic testing and risk-stratified screening was thought to raise awareness, offer reassurance and offer opportunities for early intervention. Anxiety was only mentioned in relation to receiving a diagnosis of OC and not with screening per se. Perhaps because lay models of cancer already embrace both environmental and genetic factors, a low-risk result was not anticipated to result in a false sense of immunity. Unexpectedly, participants also wanted to receive cancer prevention advice in conjunction with genetic testing; screening alone was not regarded as sufficient. CONCLUSION: The encouraging results from this small study warrant further large-scale research into risk-stratified OC screening.

Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, body mass index, hysterectomy, hormone therapy use, lifestyle and mood in a cross-sectional cohort study of 10,418 British women aged 54-65.

OBJECTIVE: Hot flushes and night sweats (HFs/NSs) are the main menopausal symptoms, but few studies have been adequately powered to examine the dimensions or predictors of experiencing HFs/NSs. We report on these variables in a large UK cohort of postmenopausal women. DESIGN: Cross-sectional cohort study. SETTING: UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) cohort. POPULATION: A cohort of 202,638 postmenopausal women, aged 50-74 years, without oophorectomy, recruited to UKCTOCS between 2001 and 2005. METHODS: Women completed a follow-up questionnaire, and those aged 54-65 years were mailed a survey in July 2008. MAIN OUTCOME MEASURES: Hot flush prevalence and hot flush rating scale. RESULTS: Of the 15,000 women mailed, 10,418 returned completed questionnaires; 90% had previously had HFs/NSs. Despite being on average 10 years postmenopausal, 54% experienced HFs/NSs (frequency of 33 per week with mean problem rating 4/10) that persisted across the age range. Past hysterectomy (OR 1.50, 95% CI 1.19-1.86), ever having smoked (OR 1.27, 95% CI 1.11-1.46) and alcohol consumption (current units) (OR 1.05, 95% CI 1.01-1.09) predicted ever having had HFs/NSs. Anxiety (OR 3.09, 95% CI 2.57-3.72), hysterectomy (OR 2.74, 95% CI 2.32-3.25), depressed mood (OR 1.57, 95% CI 1.24-1.99), years since last menstrual period (OR 0.95, 95% CI 0.94-0.96) and education (above and below 18 years) (OR 0.98, 95% CI 0.97-0.99) predicted the current prevalence of HFs/NSs. Few predictors of frequency were identified, but problem rating was associated with depressed mood, hysterectomy, skirt size increase and frequency of HFs/NSs. Past hormone therapy users who had discontinued treatment were more likely to have HFs/NSs that were more frequent and problematic. CONCLUSIONS: To date, this is the largest UK study of the experience of HFs/NSs amongst older postmenopausal women. HFs/NSs are more prevalent in this age band than has previously been assumed. These findings and the associations of smoking, hysterectomy, anxiety, depressed mood and hormone therapy use with the experience of HFs/NSs have implications for prevention and symptom management.

Influences on multidisciplinary team decision-making.

The objective is to explore how clinical decisions are made in a cancer multidisciplinary team meeting (MDM). The study design is qualitative based on participant observation, in depth interviews, and questionnaires. The research setting was weekly cancer MDM which provides a forum for clinical debate for practitioners in the field of women's health, working within one Cancer Network in England. The participants were 53 practitioners attending a weekly MDM over a 4-month period. Analysis of nonparticipant observation data and practitioner interview narratives identified key influences on the work of the MDM, and in particular decision-making. The research identified three major influences on the conduct of the MDM. First, MDM discussions are dominated by those with surgical, medical, or diagnostic expertise with limited contributions from those with a nursing, palliative, or psychosocial background. Second, decision-making is shaped by an overriding need to comply with policy initiatives concerning the organization of diagnosis and treatment. The third influence is whether the patient is known or unknown to some degree by members of the MDM. Where there is preexisting knowledge of the patient, the discussion and decision is inclusive of a wider range of disciplines. Team working in these circumstances is an acknowledged source of satisfaction and motivation. Where the patient is not known, discussion concerns only the physical details necessary to make a diagnosis and contributions from the wider team (including those with knowledge of psychosocial care) are rare. Practitioners' sphere of expertise, Department of Health policy, and familiarity of the team with the patient are key factors in shaping decision-making in MDMs.

Cancer information and support needs of statutory and voluntary sector staff working with people from ethnically diverse communities.

Cancer is difficult for people from ethnically diverse communities to cope with, because there is inequality in getting information and services to meet their needs for prevention, prompt diagnosis, treatment, care and support. Research with black minority ethnic (BME) communities indicates a lack of knowledge about cancer, and a desire for more information, yet research is highly equivocal with regard to health and social care workers' ability to provide this. The study described in this article aimed to identify the educational and support needs of health and social care workers from statutory and voluntary sectors, working with people affected by cancer in one London borough. Qualitative research methods of one-to-one interview and focus group discussion were used among 33 staff working in various community, organizational and professional settings. Two focus groups were held with cancer patients and carers to gain complementary understanding of their needs for support and information. Health and social care workers are challenged when providing cancer information and support to people from BME communities, even when the worker is of the same cultural background as the person affected by cancer. Interviewees considered that in most respects, the challenges for improving cancer care for people from BME communities are those common for all, and that the difficulty in providing and sustaining improved cancer information and support services to BME communities in their borough lies in poverty, low literacy and social exclusion as much as cultural difference.

Wider issues in pain management.

In this paper the accepted holistic approach to pain management in cancer care is scrutinized. A series of oppositions are considered to result from the essential indeterminate nature of pain, and that pain is fundamentally lived and experienced in the body. These oppositions are discussed in terms of mind-body dualism and embodiment, and in particular the body as subject and object. The discussion is illustrated with examples from research examining individual expressions of pain. Patients' powerful attempts to manipulate subject-object distinctions in recounting their experience of pain is offered as a means by which patients make sense of their pain, and connect it to their bodies and to their identity. The implications of acknowledging personal and cultural meanings attributed to pain are highlighted, with recommendations for future research and clinical practice initiatives.

Use of controlling language in the rehabilitation of the elderly.

Discussion rests on the notion that a paradox exists in the techniques used by nurses during the rehabilitation of elderly patients; and that this can be identified in the language nurses use during interactions with their patients. This language is seen as essentially controlling and as such contributing to a sense of helpless dependence rather than confident independence conducive to patients' successful rehabilitation. Social and physical antecedents to this are identified and the pertinence of issues of power and control in the lives of the elderly discussed. Supporting evidence is drawn from studies of nurse-patient verbal interaction. An attempt is made to identify and emphasize the subtle nature of 'controlling language'. Research questions are identified and the future contribution of research highlighted.