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Improving psychosocial outcomes for patients with poor prognosis gastrointestinal cancer and their carers: A randomised controlled trial

ABSTRACT: Interventions: A structured telephone intervention delivered by a cancer nurse. The primary carers of people diagnosed with poor prognosis gastrointestinal cancer (colorectal Duke’s stage D, oesophagus, stomach, pancreas, gall bladder, bile duct or small bowel) will be asked to complete a baseline questionnaire. Carers will then be randomised into the intervention or control group. Carers in the intervention group will receive five telephone calls from the cancer nurse in the 10 weeks following the patient that they are carer for is discharged from hospital (the first call is at Day 3 post-discharge and then the remaining four will be fortnightly ie Day 17, 31, 45 and 59). Calls will vary in duration and be dependent on each individual carer’s need however will be based a standardised structured screening tool. The intervention will provide information and advice to the carer on physical, psychosocial, information, practical and supportive care needs. Other needs that carers have will also be explored. It is anticipated that calls will last about 20-30 minutes. Primary outcome(s): Quality of Life (QoL). QoL of carers and patients will be measured using the SF-12, a generic measure of health-related quality of life. The SF-12 comprises of 12 items relating to physical and psychological QoL[Baseline (during the patients hospital admission) then 1, 3 and 6 months after the patient’s hospital discharge.] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Cancer-stomach,Gastrointestinal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-oesophageal (gullet)

PROVIDER: 2455240 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: A structured telephone intervention delivered by a cancer nurse. The primary carers of people diagnosed with poor prognosis gastrointestinal cancer (colorectal Duke’s stage D, oesophagus, stomach, pancreas, gall bladder, bile duct or small bowel) will be asked to complete a baseline questionnaire. Carers will then be randomised into the intervention or control group. Carers in the intervention group will receive five telephone calls from the cancer nurse in the 10 weeks following the patient that they are carer for is discharged from hospital (the first call is at Day 3 post-discharge and then the remaining four will be fortnightly ie Day 17, 31, 45 and 59). Calls will vary in duration and be dependent on each individual carer’s need. It is anticipated that calls will last about 20 minutes. Primary outcome(s): Feasibility. Feasibility of the intervention will be determined by assessing the number of calls required to achieve a successful intervention call. Mean, standard devaitions, median and range of time taken for calls at each time point will also be calculated.[Days 3, 17, 31, 45 and 59 after the patient’s hospital discharge.];Acceptability. Acceptability will be assessed by ascertaining the proportion of carers who complete each call at each time point. Demographic and clinical characteristics of carers allocated to the intevrention group who did or did not accpet or complete each call will be compared to assess the acceptability. Furthermore, qualitative semi-structured interviews will be conducted at 3 months following the patient’s hopital discharge and when the intervention is complete in order to gather detailed feedback of participant’s views of the intervention.[Days 3, 17, 31, 45 and 59 after the patient’s hospital discharge.] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: A structured telephone intervention delivered by a cancer nurse. People diagnosed with colorectal cancer (colorectal Australian clinicopathological staging (ACPS) system A to D) will be asked to complete a baseline questionnaire during thier hospital admission. Patients will then be randomised into the intervention or control group. Patients in the intervention group will receive five telephone calls from the cancer nurse in the 6 months following their discharged from hospital (the first call is at Day 3 post-discharge and then the remaining four will be at Day 10 and then 1, 3 and 6 months post-discharge). Calls will vary in duration and be dependent on each individual patient’s need. It is anticipated that calls will last about 20 minutes. Primary outcome(s): Acceptability. Acceptability will be assessed by ascertaining the proportion of patients who complete each call at each time point. Demographic and clinical characteristics of patients allocated to the intervention group who did or did not accept or complete each call will be compared to assess the acceptability. Furthermore, a series of questions will be sent to patients at 6 months following the patient’s hospital discharge and when the intervention is complete in order to gather detailed feedback of participant’s views of the intervention.[Days 3 and 10 and 1, 3 and 6 months after the patient’s hospital discharge.];Feasibility. Feasibility of the intervention will be determined by assessing the number of calls required to achieve a successful intervention call. Mean, standard devaitions, median and range of time taken for calls at each time point will also be calculated.[Days 3 and 10 and 1, 3 and 6 months after the patient’s hospital discharge.];Unmet supportive care needs will be measured using the Supportive Care Needs Survey (SCNS). The SCNS is a 34-item questionnaire that determines participants level of unmet need for a range of items for five supportive care domains.[1, 3 and 6 months after the patient’s hospital discharge.] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: Control Group: Usual care and discharge process. Number of participants: 59 patients Intervention Group: Number of participants: 59 patients On the first day of admission to the surgical unit: a nurse, previously trained, will identify a family member/caregiver who will accompany the patient at home; identify the patient’s and family’s aims for hospital stay; inform the patient and family about the steps and needs identified for discharge; discuss the discharge plan with the doctor and patient. After the surgery: meeting to prepare the patient and family for discharge - the nurse will identify needs and concerns about going home, educate the patient and family about the patient’s condition and use the teach-back technique; which consists of a method used to confirm the understanding of the patient and family about what is being explained. In this way, the nurse will explain the care for the surgical wound, use of medications, and catheters (if applicable) for the patient and family. On the day of discharge: the nurse will make a telephone call to the patient’s primary care unit of reference and pass the case / main needs of the patient to the nurse (or on the first business day following discharge); review the reconciled drug list with the patient and family; deliver a multidisciplinary hospital discharge plan/summary to the patient, with data on clinical follow-up, tests performed, diagnosis, medications in use, medications for continuous use, length of stay, a brief history of hospitalization and guidelines for the patient on continuity of care in Primary Health Care; inform the patient and family of the nurse’s name and telephone number of the Basic Unit who will be the person and unit to be contacted if there is a problem after disch;I02.233.332;E02.760.169.125 Primary outcome(s): From the intervention that the nurse will perform with the patients in the intervention group, it is expected to reduce the length of stay in hospital after colorectal cancer surgery, it will be verified through the days spent in the sector confirmed through the data in the patient’s record. ;From the intervention that the nurse will perform with the patients in the intervention group, it is expected to reduce unplanned hospital readmission in 30 days, 60, and 90 days, it will be verified through the data from the patient’s record.;From the intervention that the nurse will perform with the patients in the intervention group, it is expected to reduce emergency visits in 30, 60 and 90 days, it will be verified through data from the patient’s record.

Project description:SF-1 (NR5A1) was overexpressed (Over) or knocked down with shRNA (shRNA) in NCI-H295R human adrenocortical tumor cells and differential global gene expression analysed 48 hours later using Affymetrix GeneChip Human Gene 1.0ST arrays. Over: 5 million cells were transfected (Amaxa Nucleofection) with 10 ug of a pIRES2-AcGPF1-Nuc construct co-expressing SF-1 cDNA and GFP. For experimental control, a mutagenized pIRES2 construct, bearing the G35E mutation in SF-1 that impairs its transactivation function in vivo and in vitro was used. shRNA: 5 million cells were transfected (Amaxa Nucleofection) with 10 ug of the SureSilencing shRNA Plasmid for Human NR5A1 with GFP marker kit (SABioscience). For experimental control, mismatch constructs provided in the kit were used. In both experiments (Over and shRNA), cells were harvested, prepared, and submitted to fluorescence-activated cell sorting (FACS) in a MoFlo XDP sorter 48 hours after transfection. Viable GFP-expressing cells were pooled and resuspended in TRIzol reagent for RNA extraction. Total RNA was extracted, and RNA quality control performed using a 2100 Bioanalyzer. RNA samples were processed using the Affymetrix GeneChip WT Sense Target Labeling kit, starting with 200 ng total RNA. Four independent Over experiments and five independent shRNA experiments were performed and samples of labeled fragmented cDNA were hybridized to Affymetrix GeneChip Human Gene 1.0 ST Arrays. Based on quality control of array data (R/Bioconductor and Partek Genomics Suite), two Over arrays (one SF-1 wild type and one mutant control) and one shRNA array (mismatch control) were excluded and are not deposited here. Differential gene expression analysis was performed using the limma package in R/Bioconductor. A Benjamini-Hochberg-corrected P value cut-off of 0.05 was used to select significant differentially expressed genes in each setting (Over and shRNA). Finally, results from both analyses were combined to identify a subset of positively-regulated SF-1 target genes in these cells, ie transcripts up-regulated by SF-1 overexpression (Over) and down-regulated by SF-1 knockdown (shRNA). Four SF-1 overexpression experiments (Over; intervention = overexpression of wild type SF-1; control = overexpression of functionally-impaired mutant G35E SF-1) and five SF-1 knockdown experiments (shRNA; intervention = SF-1-specific small hairpin RNA; control = shRNA mismatch control) were performed in NCI-H295R cells. Differential gene expression in each setting was analysed using GeneChip Human Gene 1.0ST arrays. Data for arrays that met quality control are presented here: Over, 3 intervention and 3 control arrays; shRNA, 5 intervention and 4 control arrays. Total of 15 arrays.

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Improving psychosocial outcomes for patients with poor prognosis gastrointestinal cancer and their carers: A randomised controlled trial

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