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LivingWELL: assessing the impact of a lifestyle intervention in people attending family history clinics with an increased risk of colorectal or breast cancer.

ABSTRACT: See http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-giving-lifestyle-advice-to-people-who-have-a-family-history-of-bowel-or-breast

DISEASE(S): Patients Attending Genetic Screening For Colorectal And/or Breast Cancer Risk

PROVIDER: 2409898 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: We propose to conduct a prospective observational study to investigate how change in diet and lifestyle patterns over time impacts the development of precancerous colorectal lesions or colorectal cancer in individuals at above average risk of colorectal cancer and undergoing a colonoscopy surveillance - the ‘Southern Cooperative Program for the prevention of colorectal cancer’ (SCOOP). Data regarding patients’ colonoscopies will be extracted from the SCOOP database. Participants enrolled in the SCOOP program will be invited to complete the diet and lifestyle survey over the period of three years (in years 1 (baseline survey), 2 and 3 (follow-up surveys)). The survey can be completed by the participants either online, by clicking on a provided link or scanning a QR code. It is expected that each survey will require around 40-50 minutes to be filled out. The exposure variables include: -Dietary intake (using a validated food frequency questionnaire from the Australian Eating Survey), -Physical activity (using the International Physical Activity Questionnaire (IPAQ-L)), -Sleep patterns (Pittsburgh Sleep Quality Index (PSQI), Obstructive sleep apnoea screening questionnaire (OSAS), and Insomnia Severity Index questionnaire, -Smoking status, -Body mass index (BMI), -Aspirin intake, and -Comorbidities including diabetes. Primary outcome(s): The primary outcome of this study will be the dietary pattern that will be assessed using a validated food frequency questionnaire. [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one diet survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two diet surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three diet surveys until the next scheduled colonoscopy.];Another primary outcome of this study will be sleep quality assessed by a validated International Physical Activity Questionnaire (IPAQ-L). [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one physical activity survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two physical activity surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three physical activity surveys until the next scheduled colonoscopy.];Another primary outcome of this study will be sleep quality assessed by a validated Pittsburgh Sleep Quality Index (PSQI). [This will be assessed at baseline (year 1), years 2 and 3 at anytime during the three year observation period. Individuals whose colonoscopies are due within one year will receive only one sleep survey (baseline), while those whose colonoscopies are due in two years’ time will receive only two sleep surveys before their next scheduled colonoscopy. Most patients under surveillance will receive regular colonoscopies at intervals of 3 or 5 years, and they will be able to take part in all three sleep surveys until the next scheduled colonoscopy.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

Project description:OBJECTIVES:To assess the feasibility of delivering and evaluating a weight management (WM) programme for overweight patients with a family history (FH) of breast cancer (BC) or colorectal cancer (CRC). STUDY DESIGN:A two-arm (intervention vs usual care) randomised controlled trial. SETTING:National Health Service (NHS) Tayside and NHS Grampian. PARTICIPANTS:People with a FH of BC or CRC aged?18 years and body mass index of ?25?kg/m2 referred to NHS genetic services. INTERVENTION:Participants were randomised to a control (lifestyle booklet) or 12-week intervention arm where they were given one face-to-face counselling session, four telephone consultations and web-based support. A goal of 5% reduction in body weight was set, and a personalised diet and physical activity (PA) programme was provided. Behavioural change techniques (motivational interviewing, action and coping plans and implementation intentions) were used. PRIMARY OUTCOME:Feasibility measures: recruitment, programme implementation, fidelity measures, achieved measurements and retention, participant satisfaction assessed by questionnaire and qualitative interviews. SECONDARY OUTCOMES:Measured changes in weight and PA and reported diet and psychosocial measures between baseline and 12-week follow-up. RESULTS:Of 480 patients approached, 196 (41%) expressed interest in the study, and of those, 78 (40%) patients were randomised. Implementation of the programme was challenging within the time allotted and fidelity to the intervention modest (62%). Qualitative findings indicated the programme was well received. Questionnaires and anthropometric data were completed by >98%. Accelerometer data were attained by 84% and 54% at baseline and follow-up, respectively. Retention at 12 weeks was 76%. Overall, 36% of the intervention group (vs 0% in control) achieved 5%?weight loss. Favourable increases in PA and reduction in dietary fat were also reported. CONCLUSIONS:A lifestyle programme for people with a family history of cancer is feasible to conduct and acceptable to participants, and indicative results suggest favourable outcomes. TRIAL REGISTRATION NUMBER:ISRCTN13123470; Pre-results.

Project description:BACKGROUND:Family history (FH) is an underutilized genetically informative tool that can influence disease prevention and treatment. It is unclear how FH fits into the development of community-based health education. This study examines the role that FH plays in perceived threat and health education related to mental and chronic physical conditions in the context of the health belief model. METHODS:Data were collected from 1,048 adult participants aged 18-90 years. Approximately 76% of participants indicated African-American race/ethnicity and 35% had less than high school level education. Self-report data were collected on FH of four disorders: anxiety, depression, diabetes, and high blood pressure. Interest in receiving information regarding prevention as well as future testing efforts was assessed broadly. A series of logistic regressions examined the association between FH for each of the disorders and interest in receiving information on (1) prevention of diseases in general and (2) testing for diseases in general. These associations were also analyzed after accounting for the influence of perceived threat of conditions. RESULTS:Interest in receiving general health education was significantly associated with FH of depression (OR?=?2.72, 95% CI?=?1.74-4.25), anxiety (OR?=?2.26, 95% CI?=?1.45-3.22), and high blood pressure (OR?=?2.54, 95% CI?=?1.05-6.12). After adjustment for perceived threat, the magnitude of these associations was reduced substantially. The associations between perceived threat and either interest in receiving information on disease testing or receiving general health education were strong and significant across all conditions (OR?=?2.11-3.74). DISCUSSION:These results provide evidence that perceived threat mediates the association between FH and engagement with health education. Currently available health education programs may benefit from considering the role of FH in an individual's motivation for participation in health education activities alongside other factors.