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Evaluation of a brain training programme in cancer survivors self reporting cognitive changes

ABSTRACT: Interventions: A home based, computerised cognitive rehabilitation programme to be used for 4x forty-minute sessions per week for a total of 15 weeks (i.e. 40 hours). There are five training exercises that form the core of the program, each targeting a different area of brain functioning. These cognitive targets include visual precision, divided attention, working memory, useful field of view and visual processing speed. Each exercise has an accompanying assessment that sets an improvement goal and measures progress against that goal. The exercises adapt to an individual’s performance and all patients will complete a recommended schedule of training as per the programme design. Primary outcome(s): The primary endpoint is self reported cognitive function as assessed by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-COG). The primary outcome will be the difference between the intervention group and the control group in the change in FACT-COG score on completion of the cognitive rehabilitation program compared to the baseline score.[Self reported cognitive function as measured by FACT-COG will be evaluated at 3 time points. These assessments will be at baseline, on completion of the 15 week intervention and 6 months following completion of the intervention.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Cancer-ovarian And Primary Peritoneal,Cognitive Impairment In Cancer Survivors,Cancer-breast

PROVIDER: 2455008 | 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:Interventions: The pelvic floor intervention for rectal cancer patients will be delivered in two stages: (1) pre-rehabilitation and (2) rehabilitation. There is actual recommendation to provide rehabilitation before surgeries in order to prepare patients to improve their functional outcomes. The content of pre-rehabilitation and rehabilitation will include pelvic floor exercises and other techniques aiming to recover pelvic floor maximal function after the surgery and to avoid low anterior resection syndrome (LARS) symptoms. The pelvic floor intervention, including all stages and techniques, will be provided by a physical therapist with a postgraduation study on pelvic floor treatment with experience in treating rectal cancer patients. This professional will be trained by researchers on the study protocol. The intervention will take place in a private room of Hospital del Salvador. Stage 1: Pelvic Floor Pre-rehabilitation will be delivered in one session of approximately 40 minutes with physiotherapist educating on the correct contraction of pelvic floor, teaching pelvic floor muscle exercises, and performing capacitive and sensory training with rectal balloon. Health education will include: the most adequate positioning to evacuate, self-care strategies such as diet with high fiber and low fat, reduce spicy and stimulating food (artificial sweeteners, tea, cola drinks and chocolates), and bowel habits (possibility to have increased urgency to defecate after meal or physical activities). A booklet was designed for this study with these instructions and exercises will be provided to the patients as well as an audio that will be sent to their cell phones using Whatsapp application. A mobile number with a whatsapp account will be maintained by the pelvic floor therapist to se Primary outcome(s): Mean score of bowel symptoms For the main outcome we will use the questionnaire ICIQ-B and the LARS score.[(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT) (T2) Immediatelly after pelvic floor rehabilitation (T0) baseline];Mean scores of anorectal function. High resolution anorectal manometry will be used to assess the maximal resting pressure, maximal squeeze pressure, rectal capacity (maximal tolerable volume), and rectal sensitivity (initial sensation threshold). We will use high resolution anorectal manometry with a 24-channels water-perfused catheter (Multiplex, Alacer, Biomedica, Sao Paulo, Brazil). This equipment is a low-cost water perfused system which showed to be adequate for clinical use (Silva et al, 2018; Viebig et al, 2018). According to a previous study we will define as effective an improvement of > 15% in the anorectal manometry parameters. This test will be performed by a trained physician. Silva RMB, Herbella FAM, Gualberto D. Normative values for a new wáter-perfused high resolution manometry system. Arq Gastroenterol 2018; 55:30-34 Viebig RG, Franco JTY, Araujo SV, Gualberto D. Water-perfused high-resolution anorectal manometry (hram-wp): the first brazilian study. Arq. Gastroenterol. 2018;55(Suppl 1):41-46. [(T3) Three months after finishing pelvic floor rehabilitation treatment (PRIMARY TIMEPOINT) (T2) Immediatelly after pelvic floor rehabilitation (T1) before rehabilitation - standardized at approximately 6 months of ostomy use after rectal cancer surgery (T0) baseline] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: This single centre, multidisciplinary study aims to explore the feasibility of introducing supervised, personalised exercise prescription, any time from point-of-diagnosis for 12-weeks in individuals receiving treatment for early-stage breast or colon cancer in Christchurch, New Zealand. Exercises will be individualised and prescribed by an accredited Exercise Physiologist with more than 5-years-experience. Sessions will be a combined approach of aerobic and resistance training, delivered in a hospital-based gym 1-3 x / week for up to 60 mins per session. Adherence will be assessed to investigate feasibility of the programme. There will be two options for people to self-select to participate in the research study, either in the exercise group or the non-exercise group. Once details of participation have been communicated and consent recorded, all participants will undergo a baseline assessment. From the baseline assessment, individuals in the exercise group will have an individualised exercise programme prescribed one-on-one. The aim will be to reach a combined moderate-to-high intensity resistance and cardiovascular-based programme during each session if this is possible based on how each participant presents. Cardiovascular exercises may include running, walking or biking and resistance exercises may include squats, lunges, balance and modified upper limb exercises. Participants in the non-exercise group will be advised to continue with their usual daily routines. All participants will be asked to keep a journal of their activity and to bring this journal to each assessment. Participants may be referred at any time within the preoperative phase, and therefore the number of sessions completed prior to surgery will vary. Following surgery the exercise will no Primary outcome(s): Determine feasibility of introducing a supervised, personalised exercise programme from point of diagnosis through surgery and chemotherapy in individuals with early-stage breast or colon cancer in the New Zealand clinical setting. This will be evaluated by the composite primary endpoint of participant attendance (ratio of total attended to planned treatments >70%) and loss to follow-up (non-completion of exercise intervention assessments (< 20% LTF). Attendance checklists will be used to monitor attendance and any lost to follow up participants.[On completion of the exercise programme. ] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel

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Evaluation of a brain training programme in cancer survivors self reporting cognitive changes

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