Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients (PROTECT) : rationale and design of a randomized controlled trial

Published: 6 January 2014BACKGROUND: Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted. METHODS/DESIGN: This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs. DISCUSSION: This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.Patricia M Livingston, Richard H Osborne, Mari Botti, Cathy Mihalopoulos, Sean McGuigan, Leila Heckel, Kate Gunn, Jacquie Chirgwin, David M Ashley and Melinda William

Psychometric properties of cancer survivors' unmet needs survey

Purpose: This study aims to develop a psychometrically rigorous instrument to measure the unmet needs of adult cancer survivors who are 1 to 5 years post-cancer diagnosis. “Unmet needs” distinguishes between problems which survivors experience and problems which they desire help in managing. Methods: The survey was developed from a comprehensive literature review, qualitative analysis of the six most important unmet needs of 71 cancer Survivors, review of the domains and items by survivors and experts, cognitive interviews and a pilot test of 100 survivors. A stratified random sample of 550 cancer survivors, selected from a population-based Cancer Registry, completed a mailed survey to establish reliability and validity. Results: The final 89-item Survivors Unmet Needs Survey (SUNS) has high acceptability, item test–retest reliability and internal consistency (Chronbach’s alpha 0.990), face, content and construct validity. Five subscales measure Emotional Health needs (33 items, 19.4% of variance), Access and Continuity of Care (22 items, 15.1%), Relationships (15 items, 12.1%), Financial Concerns (11 items, 10.3%) and Information needs (eight items, 8.1% of the variance). Conclusions: This instrument has strong psychometric properties and is useful for determining the prevalence and predictors of cancer survivors’ unmet needs across types of cancer, length of survivorship and sociodemographic characteristics. Use of the SUNS will enable more effective targeting of programmes and services and guide policy and health planning decisions. Relevance: This study is an important step toward evidencebased planning and management of problems which the growing survivor population requires assistance in managing

Annotation of full-length long noncoding RNAs with capture long-read sequencing (CLS)

Metazoan genomes produce thousands of long-noncoding RNAs (lncRNAs), of which just a small fraction have been well characterized. Understanding their biological functions requires accurate annotations, or maps of the precise location and structure of genes and transcripts in the genome. Current lncRNA annotations are limited by compromises between quality and size, with many gene models being fragmentary or uncatalogued. To overcome this, the GENCODE consortium has developed RNA capture long-read sequencing (CLS), an approach combining targeted RNA capture with third-generation long-read sequencing. CLS provides accurate annotations at high-throughput rates. It eliminates the need for noisy transcriptome assembly from short reads, and requires minimal manual curation. The full-length transcript models produced are of quality comparable to present-day manually curated annotations. Here we describe a detailed CLS protocol, from probe design through long-read sequencing to creation of final annotations