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Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.

ABSTRACT: 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.

SUBMITTER: Anderson AS

PROVIDER: S-EPMC5879797 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.

Anderson Annie S AS Dunlop Jacqueline J Gallant Stephanie S Macleod Maureen M Miedzybrodzka Zosia Z Mutrie Nanette N O'Carroll Ronan E RE Stead Martine M Steele Robert J C RJC Taylor Rod S RS Vinnicombe Sarah S Berg Jonathan J

BMJ open 20180201 2

<h4>Objectives</h4>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).<h4>Study design</h4>A two-arm (intervention vs usual care) randomised controlled trial.<h4>Setting</h4>National Health Service (NHS) Tayside and NHS Grampian.<h4>Participants</h4>People with a FH of BC or CRC aged≥18 years and body mass index of ≥25 kg/m<sup>2</sup> referred to NHS genetic ...[more]

PMID: 29391383

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Project description:ObjectivesTo assess the feasibility of delivering and evaluating a lifestyle programme for patients with colorectal cancer undergoing potentially curative treatments.Study designNon-randomised feasibility trial.SettingNational Health Service (NHS) Tayside.ParticipantsAdults with stage I-III colorectal cancer.InterventionThe programme targeted smoking, alcohol, physical activity, diet and weight management. It was delivered in three face-to-face counselling sessions (plus nine phone calls) by lifestyle coaches over three phases (1: presurgery, 2: surgical recovery and 3: post-treatment recovery).Primary outcomeFeasibility measures (recruitment, retention, programme implementation, achieved measures, fidelity, factors affecting protocol adherence and acceptability).Secondary outcomesMeasured changes in body weight, waist circumference, walking and self-reported physical activity, diet, smoking, alcohol intake, fatigue, bowel function and quality of life.ResultsOf 84 patients diagnosed, 22 (26%) were recruited and 15 (18%) completed the study. Median time for intervention delivery was 5.5?hours. Coaches reported covering most (>70%) of the intervention components but had difficulties during phase 2. Evaluation measures (except walk test) were achieved by all participants at baseline, and most (<90%) at end of phase 2 and phase 3, but <20% at end of phase 1. Protocol challenges included limited time between diagnosis and surgery and the presence of comorbidities. The intervention was rated highly by participants but limited support from NHS staff was noted. The majority of participants (77%) had a body mass index>25?kg/m2 and none was underweight. Physical activity data showed a positive trend towards increased activity overall, but no other changes in secondary outcomes were detected.ConclusionsTo make this intervention feasible for testing as a full trial, further research is required on (a) recruitment optimisation, (b) appropriate assessment tools, (c) protocols for phase 2 and 3, which can build in flexibility and (d) ways for NHS staff to facilitate the programme.Trial registration numberISRCTN52345929; Post-results.

Project description:BACKGROUND:Studies have shown that the quality of family health history (FHH) collection in primary care is inadequate to assess disease risk. To use FHH for risk assessment, collected data must have adequate detail. To address this issue, we developed a patient facing FHH assessment tool, MeTree. In this paper we report the content and quality of the FHH collected using MeTree. METHODS: DESIGN:A hybrid implementation-effectiveness study. Patients were recruited from 2009 to 2012. SETTING:Two community primary care clinics in Greensboro, NC. PARTICIPANTS:All non-adopted adult English speaking patients with upcoming appointments were invited to participate. INTERVENTION:Education about and collection of FHH with entry into MeTree. MEASURES:We report the proportion of pedigrees that were high-quality. High-quality pedigrees are defined as having all the following criteria: (1) three generations of relatives, (2) relatives' lineage, (3) relatives' gender, (4) an up-to-date FHH, (5) pertinent negatives noted, (6) age of disease onset in affected relatives, and for deceased relatives, (7) the age and (8) cause of death (Prim Care31:479-495, 2004.). RESULTS:Enrollment: 1,184. Participant demographics: age range 18-92 (mean 58.8, SD 11.79), 56% male, and 75% white. The median pedigree size was 21 (range 8-71) and the FHH entered into MeTree resulted in a database of 27,406 individuals. FHHs collected by MeTree were found to be high quality in 99.8% (N = 1,182/1,184) as compared to <4% at baseline. An average of 1.9 relatives per pedigree (range 0-50, SD 4.14) had no data reported. For pedigrees where at least one relative has no data (N = 497/1,184), 4.97 relatives per pedigree (range 1-50, SD 5.44) had no data. Talking with family members before using MeTree significantly decreased the proportion of relatives with no data reported (4.98% if you talked to your relative vs. 10.85% if you did not, p-value < 0.001.). CONCLUSION:Using MeTree improves the quantity and quality of the FHH data that is collected and talking with relatives prior to the collection of FHH significantly improves the quantity and quality of the data provided. This allows more patients to be accurately risk stratified and offered appropriate preventive care guided by their risk level. TRIAL NUMBER:NCT01372553.

Dataset Information

Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.

Publications

Feasibility study to assess the impact of a lifestyle intervention ('LivingWELL') in people having an assessment of their family history of colorectal or breast cancer.

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