PARC (Promoting Adhesion to Referral for Colonoscopy) study: to compare different ways to invite subjects with a positive fecal occult blood test to colonoscopy
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer Screening Programmes
PROVIDER: 2422039 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Background and study aims
An advance notification letter conveying information on colorectal cancer (CRC) risk and the intervention offered in the screening programme, may increase the likelihood of a positive response to the subsequent screening invitation, as the subject will have progressed in his degree of readiness for change. In addition, it has been shown that, in particular for less educated subjects, general practitioners (GP) advice may have a strong influence on the decision to be screened. The study aims to assess the impact on the response rate to the invitation for CRC screening, in the context of population based programs, of an advance notification letter mailed to subjects eligible for invitation. The additional cost per person examined and the additional workload for the subjects GPs will be assessed.
Who can participate?
All subjects (male and female) aged 50 to 69 targeted for CRC screening in 8 population based programmes in Italy.
What does the study involve?
During the enrolment period all subjects targeted for invitation in these screening programs were randomly allocated to three groups:
A: standard personal invitation letter, signed by the GP, to undergo CRC screening
B: advance notification letter, mailed one month before the standard invitation letter (same as in A), conveying information on CRC risk, on the screening program and on the expected benefits and potential harms of screening
C: as in B, with the addition, in the advance notification letter, of the offer of a personal encounter with the subjects GP, to discuss pros and cons of screening. The response rate across the different groups will be assessed at 6 months following the invitation letter.
| 2424734 | ecrin-mdr-crc
Project description:The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.
| 2127685 | ecrin-mdr-crc
Project description:Low-grade, chronic inflammation during ageing (“inflammageing”) is suggested to be involved in the development of frailty in older age. However, studies on the association between frailty, using the frailty index definition, and inflammatory markers are limited. The aim of this study was to investigate the relationship between inflammatory markers and frailty index (FI) in older, home-dwelling adults. Home-dwelling men and women aged ≥ 70 years old, living in South-East Norway were recruited and included in a cross-sectional study. The FI used in the current study was developed according to Rockwood’s frailty index and included 38 variables, resulting in an FI score between 0 and 1 for each participant. Circulating inflammatory markers (IL-6, CRP, IGF-1, cystatin C, cathepsin S, and glycoprotein Acetyls) were analyzed from non-fasting blood samples using ELISA. Whole-genome PBMC transcriptomics was used to study the association between FI score and inflammation. The present study was a cross-sectional study that included home-dwelling men and women aged ≥ 70 years old, living in the Skedsmo area, South-East Norway. The study was conducted in 2014/2015 and has been described previously [Ottestad I, Ulven SM, Øyri LKL, Sandvei KS, Gjevestad GO, Bye A, et al. Reduced plasma concentration of branched-chain amino acids in sarcopenic older subjects: a cross-sectional study. Br J Nutr. 2018;120(4):445-53]. The participants were recruited by the National Register and received an invitation letter by mail. Briefly, a total of 2820 subjects were invited, and 437 subjects participated in the study. The participants met for a single study visit, and data was collected on dietary intake, body weight and composition, physical performance, medical history, cognitive function, risk of malnutrition, anthropometric measurements, blood pressure, heart rate, and quality of life. Non-fasting blood samples were also collected.
2023-09-01 | GSE236927 | GEO
Project description:Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.
| 2065608 | ecrin-mdr-crc
Project description:Research on the Transcendental Meditation (TM) technique suggests it is a powerful intervention for reducing the unwanted effects of stress. Investigations of the TM program as a therapeutic intervention include cardiovascular disease (CVD), post-traumatic stress disorder (PTSD), and anxiety disorders. Healthcare utilization studies show reductions in diseases after regular practice of the program. This study compared long-term practitioners of TM (38 ± 4 years) with non-practitioner controls. We used DNA microarray global transcriptomics technologies in Peripheral Mononuclear Blood Cells (PMBCs) to compare a non-practitioner control group (Group III) and a TM-practitioner group (Group IV). Demographically-matched groups of 6 each were studied. These results are expected to be relevant to stress and stress-related diseases such as CVD, diabetes, and PTSD.
2021-03-26 | E-MTAB-10252 | biostudies-arrayexpress
Project description:Background and study aims
In European countries, colorectal cancer (CRC, also known as bowel cancer) represents an important public health problem. Screening by a faecal occult blood test (FOBT, a test for the detection of blood in the faeces which is not visually apparent) has proven to be effective in reducing CRC mortality. Currently, population-based screening programmes using FOBT have been or are heading towards being implemented in many European countries. Faecal immunochemical test (FIT, another test for the detection of blood in the faeces which is not visually apparent) has been adopted by most Italian regions as the default screening test. Flexible sigmoidoscopy (FS, an exam used to evaluate the lower part of the large intestine (colon) using a thin, flexible tube (sigmoidoscope) is inserted into the rectum) screening offered to people 58 years old has shown to reduce CRC. Although, the attendance rate in CRC screening programmes still remains suboptimal in Italy. Numerous international agencies recommend, among the tests able to identify CRC and precancerous lesions, CT Colonography (CTC), or “virtual colonoscopy”, with a five-year interval. Some trials have evaluated CTC as a screening test, with contradictory results. Recently a new approach based on “behavioural economics” (BE) concepts has been proposed with the aim to provide new insights into people’s behaviours and suggest new tools to promote screening uptake. Thus, the idea to design screening invitation letters according to new behavioural concepts seems appealing.
The aim of the project is to evaluate the impact on CRC screening attendance of different strategies for inviting people.
Who can participate?
For this study, 84,600 people of both gender and aged 54-70 years, non-respondents to FIT-based screening, will be randomised into six groups.
What does the study involve?
A total of 79,600 people will be invited to get a FIT; subjects randomised in arms 1a, 1b and 1c will be invited by mail with three different types of experimental letters drafted according to BE principles, whereas 40,000 subjects will be invited with a standard invitation letter (arm 2). Lastly, 3,000 subjects and 2,000 subjects will be invited to undergo an FS or a CTC examination, respectively (arm 3 and arm 4). Our project will be carried out in the territories of the three Local Health Units of Tuscany. The attendance rate will be compared among the six groups, in order to assess the efficacy of single strategies.
A qualitative phase will aim to develop the experimental invitation letter models containing messages drafted according to behavioural economics concepts of normative feedback and minority norm. This material will be evaluated through Interviews, in order to collect participants views on behavioural economics messages and to assess the comprehensibility and clarity of the texts. Interviews will be carried out with volunteers of both genders (selected from screening archives) non-respondents to CRC screening.
In this part of the project, the readability of the invitation letters will be also evaluated. In particular, possible reading comprehension difficulties met by subjects will be correlated with their personal information such as age, sex, etc. For this purpose, READ-IT (http://www.italianlp.it/demo/read-it/), the first readability assessment tool existing for the Italian language, will be exploited.
This study started from the pilot (involving ISPRO-Florence, CPO-Piedimont, ASL Roma 2-Lazio, Latina-Lazio) which aimed to increase participation in the FIT using strategies proposed by a new approach based on "behavioural economics”. The pilot involved a sample composed of 12,600 people randomly selected and allocated to the different arms. 50% of the participants belonged to the control group and received the standard invitation letter. The remaining 50% was divided into 3 equal large treatment groups and they were sent different invitation letters.
What are the possible benefit and risks of participation?
Subjects who usually do not respond to the screening invitation may choose to undertake the test due to the invitation strategy. In this case, the patient will benefit from the prevention efficacy of screening. The screening methodologies implemented in the tests are all validated and suggested at a national level. However, risks related to endoscopic procedures are different from those related to FIT tests.
Where is the study run from?
Institute for cancer research, prevention, and clinical network in Florence, Italy, is the coordinating centre of the project. The other centers involved in the study are CPO Piemonte, ASL Roma 2, ASL Latina, Local Health Unit Toscana Nord Ovest, Local Health Unit Toscana Sud-Est, Local Health Unit Toscana Centro.
When is the study starting and how long is it expected to run for?
January 2017 to December 2024.
Who is funding the study?
The pilot phase was part of a European Project funded by the European Commission [SRSS/S2018/066]. The full trial is funded by the Tuscany Region [DD 975 16/01/2020]
Who is the main contact?
Dr Paola Mantellini, p.mantellini@ispro.toscana.it
| 15038 | ecrin-mdr-crc
Project description:CD8 T cells (TCs) expressing active STAT5 (STAT5CA) transcription factors were found to be superior to un-manipulated counterparts in their long-term persistence, capacity to infiltrate a tumor, thrive in its microenvironment and induce its regression. STAT5CA induced sustained expression of genes controlling tissue homing, cytolytic granule composition, Tc-1-associated effector molecules (GranzymeB+/IFNg+/TNFa+/CCL3+ but IL-2-) and potential for secondary responses. Sustained expression of both T-Bet and Eomes transcription factors was correlated with STAT5 binding to their corresponding genes by ChIPSeq analyses. Additionally, STAT5CA-expressing CD8 TCs demonstrated reduced IL-6R/TGFbRII expression and dampened IL-6 and TGFb1 signaling. Altogether, concerted STAT5/T-Bet/Eomes regulation controls homing, recall responses and resistance to Tc-17 polarization in CD8 TCs.
2013-09-13 | GSE41818 | GEO
Project description:Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.
The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).
| 2184108 | ecrin-mdr-crc
Project description:Intervention 1: The participants of intervention group receives health belief model-based training content within Multimedia tool. For follow up,the subjects will receive in every two week one phone contact, also they will receive a call in the second month. Intervention 2: The participants of intervention group receives Motivation-protection-based training content within Multimedia tool. For follow up,the subjects will receive in every two week one phone contact, also they will receive a call in the second month. Intervention 3: control group receives clinical routine education.;Prevention;Prevention;Prevention;The participants of intervention group receives health belief model-based training content within Multimedia tool. For follow up,the subjects will receive in every two week one phone contact, also they will receive a call in the second month.;The participants of intervention group receives Motivation-protection-based training content within Multimedia tool. For follow up,the subjects will receive in every two week one phone contact, also they will receive a call in the second month.;control group receives clinical routine education
Primary outcome(s): Preventive Nutrition pattern. Timepoint: Before education and 3 months later. Method of measurement: three-day recall alimentary questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
| 2493839 | ecrin-mdr-crc
Project description:Interventions: Name of intervention: gender specific mail-administered screening invitation strategies.
All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening.
The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline.
Baseline: Advance notification letter sent
Week two: Invitation package sent
Week eight: Reminder letters sent to those who have not completed an FOBT
Week 14: Data collection ceases.
Arm 1: Control
The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP).
The standard offer includes an advance notification letter and a screening invitation package.
The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening.
The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a particip
Primary outcome(s): Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.[At 14 weeks from baseline, 12 weeks after receiving the FOBT.]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy
| 2458819 | ecrin-mdr-crc