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EXercise And Colo-Rectal Cancer Trial

ABSTRACT: 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.

DISEASE(S): Rectal Neoplasms,Colorectal Neoplasms,Colo-rectal Cancer

PROVIDER: 2202549 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen du Primary outcome(s): Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion. [Post intervention program (12 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

Project description:Many cancer survivors suffer from impairments in skeletal muscle (SkM), both in terms of reduced mass and function. Interestingly, human SkM possesses an epigenetic memory of earlier stimuli, such as exercise. Long-term retention of epigenetic changes in SkM following cancer survival and/or exercise training have not yet been studied. We therefore investigated genome-wide DNA methylation (the methylome) in SkM following a 5-month, 3/week treadmill-based aerobic training intervention in breast cancer survivors 10-14 years after diagnosis and treatment. These results were compared to breast cancer survivors who remained untrained and to age-matched controls with no history of cancer, who undertook the same training intervention. SkM biopsies were obtained before (pre) and after (post) the 5-month training period and DNA methylation was analysed using InfiniumEPIC 850K Arrays. The breast cancer survivors displayed a significant retention of increased DNA methylation (i.e., hypermethylation) at a larger number of differentially methylated positions (DMPs) compared with healthy age-matched controls pre-training. Training in cancer survivors led to an exaggerated number of DMPs with a hypermethylated signature occurring at more random non-regulatory regions across the DNA compared with training in healthy age-matched controls. However, the opposite occurred in important gene regulatory regions, where training in cancer survivors elicited a considerable reduction in methylation (i.e., hypomethylation) in 99% of the DMPs located specifically in CpG islands within promoter regions. Importantly, training was able to reverse the hypermethylation identified in cancer survivors back towards a hypomethylated signature that was observed pre-training in healthy age-matched controls at 300 (out of 881) of these island and promoter associated CpG sites. Pathway enrichment analysis identified that the training in cancer survivors evoked this predominantly hypomethylated signature in pathways associated with: Cell cycle, DNA replication and repair, transcription, translation, mTOR signalling and proteosome. Differentially methylated region (DMR) analysis also identified genes: BAG1, BTG2, CHP1, KIFC1, MKL2, MTR, PEX11B, POLD2, S100A6, SNORD104 and SPG7 as hypermethylated in breast cancer survivors with training reversing these CpG island / promoter associated DMRs towards a hypomethylated signature. Training also elicited a largely different epigenetic response in healthy individuals than that observed in cancer survivors, with very few overlapping changes. Only one gene, SIRT2, was identified as having altered methylation in cancer survivors at baseline as well as after training in both the cancer survivors and healthy controls. In conclusion, human SkM muscle retains a hypermethylated signature for as long as 10-14 years after breast cancer treatment and survival. Importantly, 5 months of aerobic training rejuvenated the SkM methylome towards signatures identified in healthy age-matched individuals in gene regulatory regions.

Project description:Interventions: This will be a randomized controlled trial to evaluate the feasibility and effects of a 12-week Guolin Qigong (GQ) intervention (compared to usual care) on fatigue, depression, sleep quality and diurnal cortisol slope of 60 breast, lung and colorectal cancer survivors who meet the inclusion and exclusion criteria and provide written consent. All outcomes will be assessed at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention) and Week-16 (4 weeks post- intervention). At baseline (Week-1), participants will undergo a baseline assessment of questionnaires, and provide urinary samples (for 24-hour urinary cortisol test) a day prior to enrolment date to assess urinary cortisol and complete Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI) and Centre for Epidemiologic Studies Depression (CES-D). At mid-intervention (week-6) and 4 weeks after completion of intervention (Week-16) BFI, PSQI and CES-D will be collected. Post-intervention (week-12) data collection will include both the three patient reported outcomes and urinary cortisol outcome. Adherence, attendance, and any adverse event will be recorded throughout the intervention period from Week-1 to Week-12 in the practice diary by the participants randomised to GQ group. The GQ intervention will include 12 weeks of face-to-face (F2F) training class in the hospital with home practice on non-class days. There will be two F2F training classes/ week of two hours each for the first two weeks to intensify the opportunity to learn the practice well and once a week for the remaining period. The frequency of home practice will be three to four times a week over the 12-week intervention period with one and a half hours to 2 hours a day of training recommended to have efficacy. Primary outcome(s): Feasibility of GQ intervention as a composite primary outcome assessed by recruitment, retention, adherence rate and adverse events (for safety) if any, using a practice diary. However, we do not anticipate any serious adverse events based on past studies of Qigong intervention conducted to improve cancer symptoms or side effects of cancer survivors.[End of Week-12 intervention.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

Project description:Interventions: There will be two groups of participants, Home Exercise and Usual Care. Participants in both groups will be screened for risk to participate in exercise testing by an Accredited Exercise Physiologist (AEP) and be asked standardised questions about their health history related to their current medical condition. Surveys and questionnaires are: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (QLQ-CR29 and QLQ-CR30), The Active Australia questionnaire, The Exercise Confidence Survey, The Cancer Fatigue Scale, and the CSIRO Health Diet Score. Then, if safe to proceed, each participant will undertake an assessment of their body composition (height, weight and body mass index), cardiovascular measures (blood pressure, heart rate, and oxygen saturation), and physical fitness (a Six Minute Walk test, a handgrip test, and a 30 second sit-to-stand test). These assessments will be undertaken by all participants, by the same AEP research assistant at baseline (before any intervention), and follow up after an 8 week intervention period. Participants in both groups will be given information handouts at the baseline session on exercising right for bowel cancer, eating well with bowel cancer, and looking after your bowel. These baseline information handouts are publicly available from advocacy websites located: - Exercising and Colon Cancer can be found at Exercise is Medicine - http://exerciseismedicine.com.au/wp-content/uploads/2016/11/2014-Colon-Cancer-FULL.pdf - Eating well with Bowel Cancer located at: http://www.mediafire.com/download/29q69ghc92nu6lk/Eating_Well_Living_with_Bowel_Cancer_Bowel_Cancer_Australia.pdf - Looking after your bowel can be found at: https://www.continence.org.au/download_attachment.php/72e6c1218d4a5a359ad08be1dcef0f5f/01tA0000001b1daIAA/00PG0000003NBs6MAG/looking-after-your-bowel-booklet.pdf People volunteering to join the Home Exercise group w Primary outcome(s): Feasibility and acceptability: Semi-structured interview questions & discussion groups: Three-to-four participants in the Exercise Group will be sought with an ‘opt in’ approach, to attend a pre (baseline timepoint) and a post (follow up timepoint) discussion session where a study investigator experienced in qualitative research methods will explore and record conversations on participant knowledge, attitudes and beliefs around the use of technology to support lifestyle changes.. Pre- and post-intervention semi-structured interview questions will guide small group discussions. [Home Exercise Group ONLY Baseline and (post 8 week intervention) Follow up time points];Physical Function: The Six Minute Walk Test The six-minute walk test will be used as the primary measure of physical function. This test requires minimal equipment and is quick and easy to conduct, with walking distance of less than 350m being predictive of increased cardiovascular mortality risk. Participants will be instructed to walk as far as possible along a short measured course during the six minutes. They will be permitted to stop and rest if needed and will receive regular encouragement throughout the test. The 6MWT is a reliable and valid measure of physical function in adults with chronic disease and will be delivered according to standardised operating procedures Rasekaba, T., et al., The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J, 2009. 39(8): p. 495-501. Harada, N.D., V. Chiu, and A.L. Stewart, Mobility-related function in older adults: assessment with a 6-minute walk test. Arch Phys Med Rehabil, 1999. 80(7): p. 837-41 [Home Exercise Group and Usual Care Group Baseline and (post 8 week intervention) Follow up time points];Quality of Life Health related quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire QLQ-CR-30 questionnaire validated for people with colorectal cancer Aaronson, N.K., et al., The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993. 85(5): p. 365-76.[Home Exercise Group and Usual Care Group Baseline and (post 8 week intervention) Follow up time points] Study Design: Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

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EXercise And Colo-Rectal Cancer Trial

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