Colo-rectal CancerEXACTNCT02607787
EXercise And Colo-Rectal Cancer Trial
A study testing Exercise in people with Colo-rectal Cancer, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Belfast City Hospital
Belfast, Antrim, BT9 7AB
Jane Rankin, MSc, 028 9069 9369, jane.rankin1@belfasttrust.hscni.net
About this study
Official title: The Feasibility and Effects of a Home-based Walking and Strengthening Intervention on Physiological, Biochemical and Psychological Outcomes in Colo-rectal Cancer Survivors
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.
Read the detailed description
The number of people living with and beyond cancer is ever increasing and now more than ever there is a need to facilitate the appropriate rehabilitation of these patients. Exercise interventions and increased physical activity have been well documented in their ability to improve multiple aspects of health in cancer survivors; including quality of life, fatigue as well as all-cause and cancer-specific mortality. Whilst the main outcome from this study will be its feasibility, the novel aspect is the analysis of biological markers in the blood. Although there is much evidence on the benefits of exercise for colo-rectal cancer survivors, the biological mechanisms underlying its effects in this population are still elusive. Therefore this intervention was designed to investigate the feasibility and effectiveness of a home-based walking and strengthening programme on physiological, biochemical and psychological outcomes in colo-rectal cancer survivors.
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
- Colo-rectal Cancer
- Being tested
- Exercise, Control
- Keywords
- Exercise Rehabilitation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (10)
Physical activity
The participants will wear an 'ActiGraph' accelerometer around their waist for 7 consecutive days in order to calculate their activity levels.This will be measured by analyzing the minutes spent in moderate/vigorous/sedentary behaviour.
Measured: For 7 days at three different times; baseline, week 11 and week 23.
Cardiovascular Endurance
Participants walk between two cones 30 metres apart for six minutes. The cones are in a closed off corridor in the hospital with no obstructions. This is measured in meters covered in the 6 minutes.
Measured: Week 0, 12 and 24
Lower limb strength
The 30 second sit-to-stand test requires the participants to sit down and stand up from a chair as many times as they can in 30 seconds. The outcome is the number of repetitions completed.
Measured: Week 0, 12 and 24
Quality of life
Various validated questionnaires will be given to assess quality of life and fatigue; Positive and Negative Affect Schedule (PANAS), EQ-5D-3L questionnaire, FACT-C and FACT-F.
Measured: Week 0, 12 and 24
Demographics
A specially designed demographics questionnaire to gain an insight into the participant characteristics. Outcomes measured will be; age/ethnicity/employment status/marital status.
Measured: Week 0, 12 and 24
Height
Height will be measured in metres/cm.
Measured: Week 0, 12 and 24
Venous blood sample
A 34ml venous blood sample will be taken to measure various markers.
Measured: Week 0, 12 and 24
Weight
Weight will be measured in kg.
Measured: Week 0, 12 and 24
Hip and waist circumference
Measured using a measuring tape in cm.
Measured: Week 0, 12 and 24
Capillary blood sample
Finger prick test performed to measure metabolism related markers.
Measured: Week 0, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Jackie Gracey, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607787
- Sponsor's protocol ID
- 14/0061 (EXACT Study)
- Other IDs
- 14127JG-SS, 14/NI/1048
- Acronym
- EXACT
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of a Home-based Walking and Strengthening Intervention on Physiological, Biochemical and Psychological Outcomes in Colo-rectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT02607787
- Acronym / sponsor ID
- EXACT / 14/0061 (EXACT Study)
- Conditions
- Colo-rectal Cancer
- Keywords
- Exercise Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The number of people living with and beyond cancer is ever increasing and now more than ever there is a need to facilitate the appropriate rehabilitation of these patients. Exercise interventions and increased physical activity have been well documented in their ability to improve multiple aspects of health in cancer survivors; including quality of life, fatigue as well as all-cause and cancer-specific mortality. Whilst the main outcome from this study will be its feasibility, the novel aspect is the analysis of biological markers in the blood. Although there is much evidence on the benefits of exercise for colo-rectal cancer survivors, the biological mechanisms underlying its effects in this population are still elusive. Therefore this intervention was designed to investigate the feasibility and effectiveness of a home-based walking and strengthening programme on physiological, biochemical and psychological outcomes in colo-rectal cancer survivors.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseAs 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. |
| Control Group | Other | Other: ControlThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise Group |
| ControlThe 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. | Other | Control Group |
Primary outcome
Feasibility
Time frame: 24 months
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.
10 secondary outcomes
Physical activity
Time frame: For 7 days at three different times; baseline, week 11 and week 23.
Cardiovascular Endurance
Time frame: Week 0, 12 and 24
Lower limb strength
Time frame: Week 0, 12 and 24
Quality of life
Time frame: Week 0, 12 and 24
Demographics
Time frame: Week 0, 12 and 24
Height
Time frame: Week 0, 12 and 24
Venous blood sample
Time frame: Week 0, 12 and 24
Weight
Time frame: Week 0, 12 and 24
Hip and waist circumference
Time frame: Week 0, 12 and 24
Capillary blood sample
Time frame: Week 0, 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Gracey, PhD principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Colo-rectal Cancer, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie Gracey, PhD (+44 28 90368284, jh.gracey@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.