EXercise And Colo-Rectal Cancer Trial

NCT02607787 | Unknown

• 3 other identifiers: 14/0061 (EXACT Study)14127JG-SS14/NI/1048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the feasibility and effectiveness of a home-based walking and strengthening intervention on physiological, biochemical and psychological outcomes in colo-rectal cancer survivors. The intervention consists of a 12-week home-based walking and strengthening programme for colo-rectal cancer survivors post any anti-cancer treatment. It aims to gradually increase participants physical activity levels so that they start achieving the recommended levels of at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise for all major muscle groups at least twice per week. As well as usual care, the intervention group will receive weekly telephone calls and a behaviour change interview at baseline. Participants will be recruited from the Cancer Centre at the Belfast City Hospital. Assessments will be taken at baseline (0 weeks), post intervention (12 weeks) and also at a 3-month follow-up (24 weeks). The control group will receive the same assessments at the same time-points however they will continue to receive usual care with the intervention information (including pedometer, exercise booklet, diary and behavioural change interview) being given at the 3-month follow-up appointment.

Conditions

Colo-rectal Cancer

Keywords

Exercise Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The feasibility of the trial will be characterized by recording such things as; the number of eligible patients, the follow-up rates, response rates to questionnaires and adherence/compliance rates.

  24 months

Secondary Outcomes (10)

• Physical activity

  For 7 days at three different times; baseline, week 11 and week 23.

• Cardiovascular Endurance

  Week 0, 12 and 24

• Lower limb strength

  Week 0, 12 and 24

• Quality of life

  Week 0, 12 and 24

• Demographics

  Week 0, 12 and 24

Study Arms (2)

Exercise Group

EXPERIMENTAL

As well as usual care, this group receive a behavioural change session and intervention information regarding the exercise programme. The home-based walking and strengthening intervention is individually tailored for each participant. They receive a booklet, diary and pedometer to guide them as well as weekly phone calls for 12 weeks to monitor their progress.

Behavioral: Exercise

Control Group

OTHER

This group attends and participates in the same assessment outcomes as the intervention group and receives usual care for the duration of the study. However they are not given any exercise instructions and do not receive the intervention information until their final assessment at week 24. They are aware of their group allocation throughout the duration of the study.

Other: Control

Interventions

Exercise BEHAVIORAL

The exercise programme aims to gradually increase participants physical activity levels so that they start achieving the recommended levels of at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise for all major muscle groups at least twice per week.

Exercise Group

Control OTHER

The control group will receive usual care whilst attending for the same 4 visits as the intervention group and have the same outcome measures tested. They will however receive the intervention information on their last visit.

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dukes A-C colo-rectal cancer patients at least 6 weeks post any-type anti-cancer treatment, as identified by the colo-rectal oncologic and surgical teams at the Cancer Centre, Belfast City Hospital, Belfast Health and Social Care Trust.
• Males and females.
• Over eighteen years of age.
• Physically able to undertake the intervention as described within the HBWS programme by Donnelly and colleagues (2010).
• Ambulatory and without use of a walking aid.

You may not qualify if:

• Still undergoing and/or scheduled for further anti-cancer treatment.
• Any presence of cognitive impairment.
• Known co-morbidities which would severely impact upon physical functioning or nutritional status such as poorly controlled diabetes, heart failure, unstable angina, degenerative neuromuscular disease, inborn errors of metabolism, mental health disorder or substance abuse.
• Already meeting the current recommended physical activity guidelines (Schmitz, et al. 2010).
• Unable to understand and communicate in written and oral English and over the phone sufficiently well enough to undertake the self-management programme and weekly telephone review.

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Belfast City Hospital

Belfast, Antrim, BT9 7AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jackie Gracey, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Gracey, PhD

CONTACT

+44 28 90368284; jh.gracey@ulster.ac.uk

Marie Murphy, PhD

CONTACT

+44 28 90366669; mh.murphy@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: November 18, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

GB (1)