Condition category
Cancer
Date applied
02/11/2010
Date assigned
02/11/2010
Last edited
03/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Chloe Grimmett

ORCID ID

Contact details

Department of Epidemiology and Public Health
Gower Street
London
WC1E 6BT
United Kingdom
-
c.grimmett@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9281

Study information

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

Acronym

Study hypothesis

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

UCLH NHS Foundation Trust Ethics Committee, 14/10/2009, ref: 09/H0715/44

Study design

Multicentre non-randomised interventional pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Feasibility, measured on trial completion

Secondary outcome measures

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

Overall trial start date

01/04/2011

Overall trial end date

29/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 30

Participant exclusion criteria

1. Any contraindications preventing participation in unsupervised physical activity
2. Those who have ileostomy/colostomy bags

Recruitment start date

01/04/2011

Recruitment end date

29/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom

Sponsor type

Government

Website

http://www.wcrf.org/

Funders

Funder type

Research organisation

Funder name

World Cancer Research Fund

Alternative name(s)

WCRF UK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25245710

Publication citations

Additional files

Editorial Notes

03/03/2016: Publication reference added.