Can consumer research panels form an effective part of the cancer research community?

The North Trent Cancer Research Network’s Consumer Research Panel (NTCRN CRP) was established in December 2001 by the Academic Unit of Supportive Care at the University of Sheffield. In three years, the CRP has succeeded in nurturing a climate of sustainable consumer involvement within the NTCRN and this has become embedded in the culture of the network. Furthermore, the panel have championed a sustainable development of consumer involvement in health and social care research by testing new ground and forging a new way of working between health professionals and patients and carers. The CRP model has been held up as an example to other cancer networks, with new panels being set up around the country to emulate its success. This paper describes the Sheffield model of patient and public involvement and using the eight key principles of successful consumer involvement in research, identified in a recent paper by Telford et al (2003), provides a useful framework for analysing the work of the Panel. This demonstrates how consumers and professionals can inform each other to work constructively and synergistically to achieve impressive research results. The need for measurable outcomes to assess the impact and effect of consumer involvement is finally explored

Protocol for the saMS trial (supportive adjustment for multiple sclerosis): a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

BackgroundMultiple Sclerosis (MS) is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a cognitive behavioural intervention compared to supportive listening to assist adjustment in the early stages of MS.MethodsThis is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks) will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks), mid-therapy (week 5 of therapy), post-therapy (15 weeks) and at six months (26 weeks) and twelve months (52 weeks) follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants’ experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. DiscussionThis trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the efficacy, cost-effectiveness and acceptability of the interventions as well as mechanisms of psychosocial adjustment.Trial registrationCurrent Controlled Trials ISRCTN91377356<br/

Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol.

BackgroundTesticular cancer diagnosis and treatment, especially given its threat to sexuality and reproductive health, can be distressing in the formative period of young adulthood and the majority of young survivors experience impairing, distressing, and modifiable adverse outcomes that can persist long after medical treatment. These include psychological distress, impairment in pursuit of life goals, persistent physical side effects, elevated risk of secondary malignancies and chronic illness, and biobehavioral burden (e.g., enhanced inflammation, dysregulated diurnal stress hormones). However, few targeted interventions exist to assist young survivors in renegotiating life goals and regulating cancer-related emotions, and none focus on reducing the burden of morbidity via biobehavioral mechanisms. This paper describes the methodology of a randomized controlled biobehavioral trial designed to investigate the feasibility and preliminary impact of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), aimed at improving distress symptoms, emotion regulation, goal navigation skills, and stress-sensitive biomarkers in young adult testicular cancer patients.MethodsParticipants will be randomized to receive six sessions of GET or Individual Supportive Therapy (ISP) delivered over 8 weeks. In addition to indicators of intervention feasibility, we will measure primary (depressive and anxiety symptoms) and secondary (emotion regulation and goal navigation skills, career confusion) psychological outcomes prior to (T0), immediately after (T1), and 12 weeks after (T2) intervention. Additionally, identified biomarkers will be measured at baseline and at T2.DiscussionGET may have the potential to improve self-regulation across biobehavioral domains, improve overall cancer adjustment, and address the need for targeted supportive care interventions for young adult cancer survivors.Trial registrationClinicaltrials.gov, NCT04150848. Registered on 28 October 2019

A randomized clinical trial comparing family-focused treatment and individual supportive therapy for depression in childhood and early adolescence

OBJECTIVE: Despite the morbidity and negative outcomes associated with early-onset depression, few studies have examined the efficacy of psychosocial treatment for depressive disorders during childhood. Integrating family in treatment could have particularly salutary effects during this developmental period. This trial compared immediate posttreatment effects of family-focused treatment for childhood depression (FFT-CD) with those of individual supportive psychotherapy (IP) for children 7 to 14 years old with depressive disorders. METHOD: Children were randomized to 15 sessions of FFT-CD (n = 67) or IP (n = 67) over 4 months. The primary treatment outcome was adequate clinical depression response, defined as at least a 50% decrease in score on the Children's Depression Rating Scale-Revised (CDRS-R). Additional outcomes included patient-centered outcomes (parent- and child-reported treatment satisfaction), remission (defined as CDRS-R score ≤28), change in continuous CDRS-R score, and change in child and parent reports of depressive and non-depressive symptoms and social adjustment. RESULTS: Significant improvement was evident across groups for depressive and non-depressive symptoms, global response, and functioning and social adjustment. Compared with children randomized to IP, children randomized to FFT-CD showed higher rates of adequate clinical depression response (77.7% versus 59.9%; number needed to treat = 5.72; odds ratio 2.29; 95% CI 1.001-5.247; t = 1.97, p = .0498). Across treatments, families reported high satisfaction; compared with IP families, FFT-CD families reported greater knowledge and skills for managing depression. There were no significant differences between treatment arms on secondary outcomes. CONCLUSION: Results support the value of psychosocial intervention, emphasize the important role that families play, and highlight the potential for FFT-CD for supporting recovery in children with depression. Clinical trial registration information-Systems of Support Study for Childhood Depression; http://clinicaltrials.gov; NCT01159041.R01 MH082856 - NIMH NIH HHS; R01 MH082861 - NIMH NIH HH

Citation analysis of Canadian psycho-oncology and supportive care researchers

Purpose: The purpose of this study was to conduct a historical review of psycho-oncology and supportive care research in Canada using citation analysis and to review the clinical impact of the research conducted by the most highly cited researchers. Methods: The lifetime journal publication records of 109 psycho-oncology and supportive care researchers in Canada were subject to citation analysis using the Scopus database, based on citations since 1996 of articles deemed relevant to psychosocial oncology and supportive care, excluding selfcitations. Three primary types of analysis were performed for each individual: the number of citations for each journal publication, a summative citation count of all published articles, and the Scopus h-index. Results: The top 20 psycho-oncology/supportive care researchers for each of five citation categories are presented: the number of citations for all publications; the number of citations for first-authored publications; the most highly cited first-authored publications; the Scopus h-index for all publications; and the Scopus h-index for first-authored publications. The three most highly cited Canadian psychooncology researchers are Dr. Kerry Courneya (University of Alberta), Dr. Lesley Degner, (University of Manitoba), and Dr. Harvey Chochinov (University of Manitoba). Conclusions: Citation analysis is useful for examining the research performance of psycho-oncology and supportive care researchers and identifying leaders among the

Attitudes towards clinical services among people who self-harm: systematic review.

BACKGROUND: Self-harm is increasingly common in many countries, is often repeated and may have other negative outcomes. AIMS: To systematically review people's attitudes towards clinical services following self-harm in order to inform service design and improvement. METHOD: A search of electronic databases was conducted and experts in the field were contacted in order to identify relevant worldwide qualitative or quantitative studies. Data were extracted independently by two reviewers with more weight given to studies of greater quality and relevance. RESULTS: Thirty-one studies met the inclusion criteria. Despite variations in healthcare systems and setting, participants' experiences were remarkably similar. Poor communication between patients and staff and a perceived lack of staff knowledge with regard to self-harm were common themes. Many participants suggested that psychosocial assessments and access to after-care needed to be improved. CONCLUSIONS: Specific aspects of care that might increase service user satisfaction and treatment adherence include staff knowledge, communication and better after-care arrangements. A standard protocol could aid regular audits of users' experiences of services

Psychometric properties of the Mental Health Recovery Star.

BACKGROUND: The Mental Health Recovery Star (MHRS) is a popular outcome measure rated collaboratively by staff and service users, but its psychometric properties are unknown. AIMS: To assess the MHRS's acceptability, reliability and convergent validity. METHOD: A total of 172 services users and 120 staff from in-patient and community services participated. Interrater reliability of staff-only ratings and test-retest reliability of staff-only and collaborative ratings were assessed using intraclass correlation coefficients (ICCs). Convergent validity between MHRS ratings and standardised measures of social functioning and recovery was assessed using Pearson correlation. The influence of collaboration on ratings was assessed using descriptive statistics and ICCs. RESULTS: The MHRS was relatively quick and easy to use and had good test-retest reliability, but interrater reliability was inadequate. Collaborative ratings were slightly higher than staff-only ratings. Convergent validity suggests it assesses social function more than recovery. CONCLUSIONS: The MHRS cannot be recommended as a routine clinical outcome tool but may facilitate collaborative care planning

Innovative psychological treatments for depression

A number of high-intensity psychosocial interventions have been shown to be as efficacious as and more enduring than medications in the treatment of nonpsychotic depression. Moreover, there have been important advances in the development of strategies to facilitate the selection of the best treatment for a given patient with a depression diagnosis. However, the demand for services is too great to be met by conventional high-intensity approaches alone. Some of the most exciting work in recent years has focused on the development of low-intensity approaches that can benefit many people and do so cost-effectively

Meta-analysis of stomatitis in clinical studies of everolimus: incidence and relationship with efficacy.

BackgroundEverolimus, an oral mammalian target of rapamycin (mTOR) inhibitor, is used to treat solid tumors and tuberous sclerosis complex (TSC). Stomatitis, an inflammation of the mucous membranes of the mouth, is a common adverse event associated with mTOR inhibitors, including everolimus. We conducted a meta-analysis of data from seven randomized, double-blind phase 3 clinical trials of everolimus to determine the clinical impact of stomatitis on efficacy and safety.Patients and methodsData were pooled from the safety sets of solid tumor [breast cancer (BOLERO-2 and BOLERO-3), renal cell carcinoma (RECORD-1), carcinoid tumors (RADIANT-2), and pancreatic neuroendocrine tumors (RADIANT-3)] and TSC studies (EXIST-1 and EXIST-2). Data from solid tumor trials and TSC trials were analyzed separately.ResultsThe rate of stomatitis was 67% in the solid tumor trials (973/1455 patients) and 70% in the TSC trials (110/157 patients). Most stomatitis events were grade 1/2, with grade 3/4 events reported in only 9% (solid tumor trials) and 8% (TSC trials) of patients. Low TSC patient numbers prevented an in-depth evaluation of stomatitis and response. In the solid tumor trials, most first stomatitis episodes (89%; n = 870) were observed within 8 weeks of starting everolimus. Patients with stomatitis occurring within 8 weeks of everolimus initiation had longer progression-free survival (PFS) than everolimus-treated patients without stomatitis in BOLERO-2 {8.5 versus 6.9 months, respectively; hazard ratio (HR), 0.78 [95% confidence interval (CI), 0.62-1.00]} and RADIANT-3 [13.9 versus 8.3 months, respectively; HR, 0.70 (95% CI, 0.48-1.04)]. A similar trend was observed in RECORD-1 [HR, 0.90 (95% CI, 0.66-1.22)] and RADIANT-2 [HR, 0.87 (95% CI, 0.61-1.22)] but not in BOLERO-3 [HR, 1.01 (95% CI, 0.75-1.36)].ConclusionsStomatitis did not adversely affect PFS, supporting the administration of everolimus in accordance with standard management guidelines