EXercise And Colo-Rectal Cancer Trial

Colo-rectal Cancer Clinical Trial

— EXACT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607787
• Other study ID #: 14/0061 (EXACT Study)
• Secondary ID: 14127JG-SS14/NI/
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2015
• Last updated: November 17, 2015
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: University of Ulster
• Contact: Jackie Gracey, PhD
• Phone: +44 28 90368284
• Email: jh.gracey[@]ulster.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms
• Rectal Neoplasms

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast	Antrim

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	For 7 days at three different times; baseline, week 11 and week 23.	No
Secondary	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.	Week 0, 12 and 24	Yes
Secondary	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.	Week 0, 12 and 24	Yes
Secondary	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.	Week 0, 12 and 24	No
Secondary	Demographics	A specially designed demographics questionnaire to gain an insight into the participant characteristics. Outcomes measured will be; age/ethnicity/employment status/marital status.	Week 0, 12 and 24	No
Secondary	Height	Height will be measured in metres/cm.	Week 0, 12 and 24	No
Secondary	Venous blood sample	A 34ml venous blood sample will be taken to measure various markers.	Week 0, 12 and 24	Yes
Secondary	Weight	Weight will be measured in kg.	Week 0, 12 and 24	No
Secondary	Hip and waist circumference	Measured using a measuring tape in cm.	Week 0, 12 and 24	No
Secondary	Capillary blood sample	Finger prick test performed to measure metabolism related markers.	Week 0, 12 and 24	Yes