Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-04-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants are first approached by their surgeon/oncologist and assessed for their eligibility. If they are deemed eligible they are then referred to the researcher in the waiting room to be given more information about the study. If interested, they receive the participant information sheet and consent forms to take home for a period of at least 24 hours, after which the researcher calls to confirm their interest. Visit 1 is then scheduled in order for the participant to sign the consent forms and receive the 'ActiGraph' accelerometer which they wear for 7 consecutive days in order to measure their baseline physical activity levels. With permission, the patients GP will be advised by letter that the patient is commencing the study.
After the seven days the participant attends the Northern Ireland Clinical Research Facility at the Belfast City Hospital for the first assessment session. The outcome measures assessed include analysis on feasibility, quality of life, fatigue, biological markers, anthropometry, strength, cardiovascular endurance and physical activity levels. The intervention group then receive the behaviour change counselling session along with the exercise booklet, diary and pedometer. Weekly phone calls are made to intervention participants for 12 weeks to monitor their progress. The control group receives usual care without weekly phone calls. On week 11 both groups are posted their accelerometer to record activity levels and then attend the City Hospital to repeat all assessments. Both groups are not contacted again until week 23 when they are posted the accelerometer for the final time and their follow-up assessments are complete. It is at this assessment session that the control group receive the behaviour change session and intervention materials.
After each assessment day, blood samples are transported via a specifically designed fridge, to the Ulster University campus to be stored at -80 degrees Celsius for future analysis. All other study information such as questionnaires and collected data are stored as per University protocol in storage containers in a designated locked room on campus.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise Group
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.
Exercise
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.
Control Group
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.
Control
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
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.
Control
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Belfast Health and Social Care Trust
OTHER
University of Ulster
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jackie Gracey, PhD
Role: PRINCIPAL_INVESTIGATOR
Ulster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Belfast City Hospital
Belfast, Antrim, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14127JG-SS
Identifier Type: OTHER
Identifier Source: secondary_id
14/NI/1048
Identifier Type: OTHER
Identifier Source: secondary_id
14/0061 (EXACT Study)
Identifier Type: -
Identifier Source: org_study_id