Feasibility of a personalised, distance-based lifestyle intervention in colorectal cancer patients

ISRCTN	ISRCTN45454522
DOI	https://doi.org/10.1186/ISRCTN45454522
Protocol serial number	9281
Sponsor	University College London Hospitals NHS Foundation Trust (UK)
Funder	World Cancer Research Fund

Submission date: 02/11/2010
Registration date: 02/11/2010
Last edited: 03/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-lifestyle-changes-after-treatment-bowel-cancer

Contact information

Dr Chloe Grimmett
Scientific

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom

Email	c.grimmett@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional pilot study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	The feasibility of a personalised, distance-based lifestyle intervention in colorectal cancer (CRC) patients who have recently completed treatment, focusing on increasing fruit and vegetable (F&V) intake, reducing red and processed meat consumption, and increasing physical activity
Study objectives	This is a pilot study to examine the feasibility and acceptability of a distance-based intervention to increase physical activity and fruit and vegetable consumption and reduce red and processed meat consumption in patients who have recently completed treatment for bowel cancer.
Ethics approval(s)	UCLH NHS Foundation Trust Ethics Committee, 14/10/2009, ref: 09/H0715/44
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon, Rectum
Intervention	This is a feasibility study without a control group, therefore all participants will receive the same intervention. Participants will be provided with written information regarding the benefits of changes in physical activity, F&V, red and processed meat consumption following bowel cancer. They will then receive 6 personalised telephone consultations over the course of 3 months (1 call every 2 weeks). These sessions, based on self-regulation theory, will take into account baseline levels of each behaviour and introduce goal setting with the aim of gradually improving behaviour and a rate that is sustainable. Participants will also be educated regarding behaviour change skills, such as self-monitoring and evaluation of behavioural goals. Participants will be given logbooks and a pedometer in order to record their behaviour.
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility, measured on trial completion
Key secondary outcome measure(s)	All measured on trial completion: 1. Acceptability 2. Blood samples to measure vitamin C, E and plasma carotene 3. Change in physical activity 4. Fatigue 5. Fruit and vegetable consumption 6. Insulin-like growth factor 1 (IGF-1) 7. Physical function 8. Quality of life (Functional Assessment of Cancer Therapy-Colorectal [FACT-C]) 9. Red and processed meat consumption
Completion date	29/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	1. Patients within 6 months of treatment completion for M0 colorectal cancer 2. Can speak and read in English 3. Aged over the age of 18 years but with no maximum age limit, either sex
Key exclusion criteria	1. Any contraindications preventing participation in unsupervised physical activity 2. Those who have ileostomy/colostomy bags
Date of first enrolment	01/04/2011
Date of final enrolment	29/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London

London
WC1E 6BT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/03/2016: Publication reference added.