Health professional attitudes and perceptions of prehabilitation and nutrition before haematopoietic cell transplantation.

BACKGROUND: Nutritional prehabilitation may improve haematopoietic cell transplantation (HCT) outcomes, although little evidence exists. The present study aimed to understand healthcare professional (HCP) perceptions of prehabilitation and nutritional care pre-HCT in UK centres. METHODS: An anonymous online survey (developed and refined via content experts and piloting) was administered via email to multidisciplinary HCPs in 39 UK adult centres, between July 2021 and June 2022. Data are presented as proportions of responses. Routine provision denotes that care was provided >70% of time. RESULTS: Seventy-seven percent (n = 66) of HCPs, representing 61.5% (n = 24) of UK adult HCT centres, responded. All HCPs supported prehabilitation, proposing feasible implementation between induction chemotherapy (60.4%; n = 40) and first HCT clinic (83.3%; n = 55). Only 12.5% (n = 3) of centres had a dedicated prehabilitation service. Nutrition (87.9%; n = 58), emotional wellbeing (92.4%; n = 61) and exercise (81.8%; n = 54) were considered very important constituents. HCPs within half of the HCT centres (n = 12 centres) reported routine use of nutrition screening pre-HCT with a validated tool; 66.7% of HCPs (n = 36) reported using the malnutrition universal screening tool (MUST). Sixty-two percent (n = 41) of HCPs reported those at risk, received nutritional assessments, predominantly by dietitians (91.6%; n = 22) using the dietetic care process (58.3%; n = 14). Body mass index (BMI) was the most frequently reported body composition measure used by HCPs (70.2%, n = 33). Of 59 respondents, non-dietitians most routinely provided dietary advice pre-HCT (82.4%; n = 28 vs. 68%; n = 17, p = 0.2); including high-energy/protein/fat and neutropenic diet advice. Prophylactic enteral feeding pre-HCT was rare, indicated by low BMI and significant unintentional weight loss. Just under half (n = 25 of 59, 42.4%) HCPs reported exercise advice was given routinely pre-HCT. CONCLUSIONS: Nutrition and prehabilitation pre-HCT are considered important and deliverable by HCPs, but current provision in UK centres is limited and inconsistent.

The Development of a Multi-Modal Cancer Rehabilitation (Including Prehabilitation) Service in Sheffield, UK: Designing the Active Together Service.

Cancer patients undergoing major interventions face numerous challenges, including the adverse effects of cancer and the side effects of treatment. Cancer rehabilitation is vital in ensuring cancer patients have the support they need to maximise treatment outcomes and minimise treatment-related side effects and symptoms. The Active Together service is a multi-modal rehabilitation service designed to address critical support gaps for cancer patients. The service is located and provided in Sheffield, UK, an area with higher cancer incidence and mortality rates than the national average. The service aligns with local and regional cancer care objectives and aims to improve the clinical and quality-of-life outcomes of cancer patients by using lifestyle behaviour-change techniques to address their physical, nutritional, and psychological needs. This paper describes the design and initial implementation of the Active Together service, highlighting its potential to support and benefit cancer patients.

The feasibility and acceptability of an app-based intervention with brief behavioural support (APPROACH) to promote brisk walking in people diagnosed with breast, prostate and colorectal cancer in the UK.

INTRODUCTION: Increased moderate to vigorous physical activity (MVPA) can improve clinical and psychosocial outcomes for people living with and beyond cancer (LWBC). This study aimed to assess the feasibility and acceptability of trial procedures in a pilot randomised controlled trial (RCT) of a theory-driven app-based intervention with behavioural support focused on promoting brisk walking (a form of MVPA) in people LWBC (APPROACH). METHODS: Participants diagnosed with breast, prostate or colorectal cancer were recruited from a single UK hospital site. Assessments at baseline and 3 months included online questionnaires, device-measured brisk walking (activPAL accelerometer) and self-reported weight and height. Participants were randomised to intervention or control (care as usual). The intervention comprised a non-cancer-specific app to promote brisk walking (National Health Service 'Active 10') augmented with print information about habit formation, a walking planner and two behavioural support telephone calls. Feasibility and acceptability of trial procedures were explored. Initial estimates for physical activity informed a power calculation for a phase III RCT. A preliminary health economics analysis was conducted. RESULTS: Of those medically eligible, 369/577 (64%) were willing to answer further eligibility questions and 90/148 (61%) of those eligible were enrolled. Feasibility outcomes, including retention (97%), assessment completion rates (>86%) and app download rates in the intervention group (96%), suggest that the trial procedures are acceptable and that the intervention is feasible. The phase III RCT will require 472 participants to be randomised. As expected, the preliminary health economic analyses indicate a high level of uncertainty around the cost-effectiveness of the intervention. CONCLUSIONS: This pilot study demonstrates that a large trial of the brisk walking intervention with behavioural support is both feasible and acceptable to people LWBC. The results support progression onto a confirmatory phase III trial to determine the efficacy and cost-effectiveness of the intervention.

International consensus is needed on a core outcome set to advance the evidence of best practice in cancer prehabilitation services and research.

Prehabilitation aims to optimise patients' physical and psychological status before treatment. The types of outcomes measured to assess the impact of prehabilitation interventions vary across clinical research and service evaluation, limiting the ability to compare between studies and services and to pool data. An international workshop involving academic and clinical experts in cancer prehabilitation was convened in May 2022 at Sheffield Hallam University's Advanced Wellbeing Research Centre, England. The workshop substantiated calls for a core outcome set to advance knowledge and understanding of best practice in cancer prehabilitation and to develop national and international databases to assess outcomes at a population level.

Evaluation of a city-wide physical activity pathway for people affected by cancer: the Active Everyday service.

PURPOSE: The primary goal of this article is to present an evaluation of a UK-based city-wide physical activity pathway for patients with a cancer diagnosis, the Active Everyday service. Active Everyday was a co-produced physical activity service for people affected by cancer. The service was underpinned by a behaviour change care pathway model developed by Macmillan Cancer Support charity. METHODS: This was a retrospective evaluation assessing physical activity levels and changes to outcome measures (fatigue, perceived health, and self-efficacy) over 6 months. Each participant self-reported their levels of physical activity for the previous 7 days at three-time points: baseline (T1), at 12-week exit from the scheme (T2), and at 6-month follow-up (T3). RESULTS: The Active Everyday service received 395 referrals, of which 252 attended a baseline assessment. Participants' fatigue and self-efficacy improved between T1 and T2 and T1 and T3. Perceived health improved across all time points. Participant exercise levels showed significant differences between T1 and T2. CONCLUSION: The service, provided over 3 years, resulted in positive health and wellbeing outcomes in people affected by cancer who engaged in the service. Future services must routinely include exercise referrals/prescriptions as a standard part of care to help engage inactive individuals. Services should focus on targeted promotion to people from ethnic minority groups, and a wide socioeconomic population.

A nationwide initiative to increase nursing and midwifery research leadership: overview of year one programme development, implementation and evaluation.

AIMS AND OBJECTIVES: To report on the development, implementation and evaluation of the first year of the National Institute for Health Research 70@70 Senior Nurse Research Leader Programme. BACKGROUND: Internationally, there is a lack of nursing and midwifery research and policy contribution to healthcare sectors. To address this, funding was obtained for a Senior Nurse and Midwife Research Leader Programme in England. The programme aimed to increase nursing and midwifery research capacity and capability and support the development of future research leaders. DESIGN: The programme had three phases: development, implementation and evaluation. The cohort study's evaluation phase consisted of a survey and qualitative written feedback. METHODS: An online survey was sent to cohort members (n = 66). Quantitative survey data was analysed in Survey Monkey. Written feedback asked cohort members to summarise their activities and any challenges. Data were thematically analysed. The "Strengthening the Reporting of Observational Studies in Epidemiology" reporting checklist was used. RESULTS: Thirty-nine (59%) cohort members responded to the survey. Responders valued being part of a network (46%), having protected time (22%) and having workplace autonomy (13%). Challenges reported included difficulties accessing online resources (32%), lack of collaborative opportunities (17%) and organisational barriers (10%). Fifty-six (85%) cohort members submitted the written report. The main themes were "relationship and profile building", "developing capability and capacity", "developing the workforce", "patient and public involvement and engagement" and "quality improvement." CONCLUSIONS: The 70@70 programme has increased the research profile of the nursing and midwifery professions at a local and national level. International healthcare systems can learn from this, by considering optimal ways to provide nurses and midwives with the tools, resources and confidence to actively contribute to research policy and practice. RELEVANCE TO CLINICAL PRACTICE: The initiatives undertaken through year 1 of the programme have created a platform through which research can be incorporated into clinical practice, education and teaching.

Allied health professional's self-reported competences and confidence to deliver physical activity advice to cancer patients at a single Centre in England.

PURPOSE: Allied Health Professionals (AHPs) are well placed to deliver physical activity advice but this is currently not routine clinical practice. Increasing evidence demonstrates physical activity can improve quality-of-life for people affected by cancer, enable behaviour change, improve survival and reduce long-term treatment effects. We aimed to understand AHPs' current knowledge and practice in advising about physical activity. MATERIALS AND METHODS: AHPs' self-reported knowledge, competency and training needs in managing physical effects of cancer, and the merits of physical activity data were collected via an online survey. The survey link was cascaded electronically to all NHS and NHS-affiliated AHPs working across several generic and non-cancer-specific healthcare interfaces across one city in England. RESULTS: Eighty AHPs responded. Forty-one percent of AHPs had patients with current or past diagnoses of cancer. Overall, AHPs reported low confidence in giving physical activity advice, with physiotherapists the most confident. 60% of respondents identified training needs concerning the impact of cancer. CONCLUSIONS: Although the merits of physical activity for people affected by cancer is clearly evidenced, low levels of AHP confidence and competence in discussing this topic limit patients' awareness and access to services. Addressing this confidence and competence has potential to improve patient outcome.

People affected by cancer frequently experience disease and treatment-related impacts which can be detrimental to physical health and well-beingPhysical activity, can restore aspects of physical health and quality of life before, during and after cancer treatmentPeople affected by cancer have frequent points of contact with Allied Health Professionals throughout the cancer pathway and beyond via a variety of rehabilitation servicesWith increased confidence, Allied Health Professionals have the potential to "make every contact count" by providing physical activity advice and information to people affected by cancer across a variety of rehabilitation settingsTraining opportunities and bespoke learning and development offers may provide the platform for improving Allied Health Professional competences and confidence to deliver physical activity advice to people affected by cancerImproving Allied Health Professional skills, knowledge and confidence for people affected by cancer has the potential to influence patient outcomes.

Sexual function of adult long-term survivors and their partners after allogeneic hematopoietic cell transplantation in Europe (S-FAST): a study from the Transplant Complications Working Party and Nurses Group of the EBMT.

Sexual dysfunction after allogeneic hematopoietic cell transplantation (allo-HCT) is a common long-term complication. We conducted a European multicenter cross-sectional study of adult allo-HCT recipients who had survived >2 years and their partners to investigate sexual functioning after HCT and to evaluate whether discussion about sexual functioning between the transplant team and the survivor and partner was perceived to have taken place. In total, 136 survivors (77 males, 59 females) and 81 partners (34 males, 47 females) participated. Median age was 56 and 54 years in male and female survivors, respectively. Forty-seven percent of male and 65% of female survivors and 57% of male and 59% of female partners reported clinically relevant sexual problems. Sixty-two percent of survivors and 79% of partners reported that sexual functioning had not been discussed with them during transplant. Standardized sexual functioning scores were correlated with self-reported health status in survivors (rho = 0.24, p = 0.009). The high prevalence of sexual dysfunction warrants additional studies focusing on the impact of changes in sexuality for patients as well as their partners. Future studies should also investigate which methods that are effective in preventing or treating sexual problems after allo-HCT.

Time to embed physical activity within usual care in cancer services: A qualitative study of cancer healthcare professionals' views at a single centre in England.

PURPOSE: An increasing number of people affected by cancer (PABC) are living longer lives as treatment continues to advance. There is growing evidence for physical activity (PA) supporting health in this population before, during and after cancer treatment, but PA advice is not part of usual care. This study investigates views of frontline oncology healthcare professionals (HCPs) in one NHS teaching hospital in England to understand the role of PA advice across cancer services. MATERIALS AND METHODS: This was a qualitative study interviewing HCPs and using thematic analysis. RESULTS: Four main themes were identified: 1. Awareness of the roles of PA in cancer; 2. Patient-specific factors in rehabilitation; 3. Cancer-specific factors in rehabilitation; 4. Barriers and opportunities to integrating PA within usual care. HCPs' awareness of the role of PA in cancer rehabilitation was low overall and PA was found not to be embedded within rehabilitation. Contrastingly, there was awareness of PA's potential to impact disease and treatment-related outcomes positively. Ideas for PA integration included training for staff and giving PA advice within consultations. CONCLUSIONS: Low awareness of benefits of PA-based rehabilitation and lack of integration in usual care contrasted with HCPs' interest in this area's potential. Training HCPs to begin the conversation with patients affected by cancer in teachable moments may increase patient access.Implications for rehabilitationIntegrating physical activity education and training for trainees and existing healthcare professionals workforce would help embed physical activity into routine clinical practice.Brief advice intervention training during every consultation, such as providing relevant individualised information and signposting, can be impactful.Physical activity within a broader cancer rehabilitation programme should be integrated as standard for every cancer patient.Individualised plans may include prehabilitation, restorative rehabilitation and palliative rehabilitation.Patient preferences and the patient experience should continue to shape service design.There is a need to ensure physical activity advice is consistent throughout healthcare settings and not fragmented between primary, secondary and tertiary care.

Cancer, Fertility and Me: Developing and Testing a Novel Fertility Preservation Patient Decision Aid to Support Women at Risk of Losing Their Fertility Because of Cancer Treatment.

Background: Women with a new cancer diagnosis face complex decisions about interventions aiming to preserve their fertility. Decision aids are more effective in supporting decision making than traditional information provision. We describe the development and field testing of a novel patient decision aid designed to support women to make fertility preservation treatment decisions around cancer diagnosis. Methods: A prospective, mixed-method, three stage study involving: 1) co-development of the resource in collaboration with a multi-disciplinary group of key stakeholders including oncology and fertility healthcare professionals and patient partners (n=24), 2) alpha testing with a group of cancer patients who had faced a fertility preservation treatment decision in the past (n=11), and oncology and fertility healthcare professionals and stakeholders (n=14) and, 3) beta testing with women in routine care who had received a recent diagnosis of cancer and were facing a fertility preservation treatment decision (n=41) and their oncology and fertility healthcare professionals (n=3). Ten service users recruited from a closed Breast Cancer Now Facebook group and the support group Cancer and Fertility UK also provided feedback on CFM via an online survey. Results: A 60-page paper prototype of the Cancer, Fertility and Me patient decision aid was initially developed. Alpha testing of the resource found that overall, it was acceptable to cancer patients, healthcare professionals and key stakeholders and it was considered a useful resource to support fertility preservation treatment decision-making. However, the healthcare professionals felt that the length of the patient decision aid, and elements of its content may be a barrier to its use. Subsequently, the prototype was reduced to 40 pages. During beta testing of the shortened version in routine care, women who received the resource described its positive impact on their ability to make fertility preservation decisions and support them at a stressful time. However, practical difficulties emerged which impacted upon its wider dissemination in clinical practice and limited some elements of the evaluation planned. Discussion: Women receiving the decision aid within the cancer treatment pathway found it helped them engage with decisions about fertility preservation, and make better informed, values-based care plans with oncology and fertility teams. More work is needed to address access and implementation of this resource as part of routine oncology care pathways.

An integrated model of exercise support for people affected by cancer: consensus through scoping.

INTRODUCTION: Exercise support for people with cancer is a national priority. The purpose of this study was to identify the success factors necessary to create a model of exercise support for people affected by cancer in a large city in the north of England. METHOD: Two groups of participants were recruited; people affected by cancer (n = 26) and professional stakeholders (n = 14) contributing to either focus groups or semi-structured interviews. Data were analysed using framework analysis. RESULTS: Results from this study suggest that the promotion of exercise is not a priority in routine cancer care. Patients identified a lack of support and difficulty attaining information as a barrier to becoming active, emphasising a gulf between the patients' needs and the health professionals' priorities. People affected by cancer and professionals agreed that exercise was beneficial to cancer patients both during and after treatment. For an exercise pathway to be successful, key factors were identified including accessibility; tailored support; social interaction; affordability; competence of exercise delivery staff. CONCLUSIONS: There was consensus on the importance of exercise and critical factors required to develop a sustainable, accessible and effective service. Evidence to inform the development of an exercise pathway for people affected by cancer is provided.Implications for rehabilitationExercise should be an included component of a cancer treatment plan, discussed and initiated from diagnosis.Health professionals have a responsibility to provide clear, consistent evidence-based advice on exercise.Exercise professionals must be appropriately trained in cancer rehabilitation according to National Institute for Health and care Excellence (2014).Individual assessments of exercise needs, preferences and cancer limitations will result in a bespoke plan of recommendations and support.The option of group activities has the advantage of increased social interaction, peer support and shared experiences.Available exercise/physical activity services should be accessible and affordable but may involve a modest contribution.

Feasibility and benefits of a structured prehabilitation programme prior to autologous stem cell transplantation (ASCT) in patients with myeloma; a prospective feasibility study.

Evidence supports the benefits of exercise-based rehabilitation in promoting recovery in myeloma patients following autologous stem-cell transplantation (ASCT). However, 'prehabilitation' has never been evaluated prior to ASCT, despite evidence of effectiveness in other cancers. Utilising a mixed method approach the authors investigated the feasibility of a mixed strength and cardiovascular exercise intervention pre-ASCT. Quantitative data were collected to determine feasibility targets; rates of recruitment, adherence and adverse events, including 6minute walking distance (6MWD) test and patient reported outcome measures (PROMs). Qualitative interviews were undertaken with a purposive sample of patients to capture their experiences of the study and the intervention. The authors recruited 23 patients who attended a mean percentage of 75% scheduled exercise sessions. However, retention rates were limited, with only 14/23 (62%) completing the programme. In these patients, the 6MWD increased from a mean of 346 to 451m (i.e. by 105m, 95% CI 62 to 148m) with no serious adverse events. Whist participants found the exercise programme acceptable and reported improvement in their physical fitness and overall mental health and wellbeing prior to ASCT, the study identified challenges in hospital attendance for the prehabilitation schedule whilst receiving induction or re-induction chemotherapy. Evaluation of digitally-enhanced directed but remote prehabilitation models for this patient group is warranted. Trial registration number NCT03135925.

International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study.

PURPOSE: Evidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions. METHODS: Semi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame. RESULTS: Forty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists' reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified. CONCLUSION: Misconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.

Long-term survivors following autologous haematopoetic stem cell transplantation have significant defects in their humoral immunity against vaccine preventable diseases, years on from transplant.

Current international guidelines recommend routinely vaccinating haematopoetic stem cell transplant (HSCT) recipients. Despite significant infection-related mortality following autologous HSCT, routine vaccination programmes (RVP) completion is poor. For recovered HSCT recipients, it is uncertain whether catch-up vaccination remains worthwhile years later. To determine potential susceptibility to vaccine preventable infections, we measured antibody titres in 56 patients, a median of 7 years (range 0-29) following autologous HSCT, who had not completed RVP. We found that almost all participants had inadequate titres against diphtheria (98.2%) and pneumococcal infection (100%), and a significant proportion had inadequate titres against measles (34.5%). Of those subsequently vaccinated according to available guidelines, many mounted adequate serological responses. These data suggest a pragmatic catch-up approach for autologous HSCT recipients who have not completed RVP is advisable, with universal vaccination against some pathogens (e.g. Streptococcus pneumoniae and diphtheria) and serologically-guided approaches for others (e.g. measles and varicella zoster virus).

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial).

Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.

The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial.

BACKGROUND: Twice-weekly supervised aerobic and resistance exercise for 12 weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required. In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care. METHODS: The intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop. RESULTS: Seven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation. CONCLUSIONS: We designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.

Testosterone replacement in young male cancer survivors: A 6-month double-blind randomised placebo-controlled trial.

BACKGROUND: Young male cancer survivors have lower testosterone levels, higher fat mass, and worse quality of life (QoL) than age-matched healthy controls. Low testosterone in cancer survivors can be due to orchidectomy or effects of chemotherapy and radiotherapy. We have undertaken a double-blind, placebo-controlled, 6-month trial of testosterone replacement in young male cancer survivors with borderline low testosterone (7-12 nmol/l). METHODS AND FINDINGS: This was a multicentre United Kingdom study conducted in secondary care hospital outpatients. Male survivors of testicular cancer, lymphoma, and leukaemia aged 25-50 years with morning total serum testosterone 7-12 nmol/l were recruited. A total of 136 men were randomised between July 2012 and February 2015 (42.6% aged 25-37 years, 57.4% 38-50 years, 88% testicular cancer, 10% lymphoma, matched for body mass index [BMI]). Participants were randomised 1:1 to receive testosterone (Tostran 2% gel) or placebo for 26 weeks. A dose titration was performed after 2 weeks. The coprimary end points were trunk fat mass and SF36 Physical Functioning score (SF36-PF) at 26 weeks by intention to treat. At 26 weeks, testosterone treatment compared with placebo was associated with decreased trunk fat mass (-0.9 kg, 95% CI -1.6 to -0.3, p = 0.0073), decreased whole-body fat mass (-1.8 kg, 95% CI -2.9 to -0.7, p = 0.0016), and increased lean body mass (1.5 kg, 95% CI 0.9-2.1, p < 0.001). Decrease in fat mass was greatest in those with a high truncal fat mass at baseline. There was no treatment effect on SF36-PF or any other QoL scores. Testosterone treatment was well tolerated. The limitations of our study were as follows: a relatively short duration of treatment, only three cancer groups included, and no hard end point data such as cardiovascular events. CONCLUSIONS: In young male cancer survivors with low-normal morning total serum testosterone, replacement with testosterone is associated with an improvement in body composition. TRIAL REGISTRATION: ISRCTN: 70274195, EudraCT: 2011-000677-31.

Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials.

BACKGROUND: Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. METHODS: We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. RESULTS: Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2-19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0-11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5-8 years and one trial publishing after 14 years. CONCLUSIONS: PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

Comprehensive geriatric assessment and decision-making in older men with incurable but manageable (chronic) cancer.

PURPOSE: In older cancer patients, treatment decision-making is often complex. A comprehensive geriatric assessment (CGA) is an established tool used in geriatric medicine to identify unmet need requiring intervention. This study aimed to assess whether using a CGA in older male cancer patients with incurable but manageable disease provides information that would alter a cancer clinician's intended management plan. Acceptability and feasibility were secondary aims. METHODS: Elderly men with incurable but manageable malignancies (advanced prostate cancer and multiple myeloma) who had previously received at least one line of treatment were recruited from hospital outpatient clinics. A CGA was undertaken. Additional parameters measuring pain, fatigue and disease-specific concerns were also recorded, at the recommendation of patient involvement groups. Results were made available to clinicians. Patient and clinician acceptability and changes in subsequent management were recorded. RESULTS: Forty-eight patients completed the study. The median ages were 70.8 years and 74 years for myeloma and prostate respectively. Most identified concerns are related to disease-specific concerns (93%), pain (91%), frailty (57%) and nutrition (52%). Results altered the clinician's oncological management plan in nine cases only. Patients found the format and content of CGA acceptable. CONCLUSIONS: Many unmet needs were identified in this population of elderly men with manageable but non curable cancer which led to supportive care referrals and interventions. The CGA, however, did not result in significant changes in clinical oncology treatment plans for the majority of patients. The application of the CGA and other assessments was viewed positively by participants and can feasibly be undertaken in the outpatient oncology setting.