Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
Ontology highlight
ABSTRACT:
DISEASE(S): Colon Cancer,Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2040026 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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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
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Project description:Study Design Retrospective cohort controlled study. Objective To determine quality-of-life (QOL) outcomes for patients with lumbar spinal stenosis (LSS) treated with membrane-stabilizing agents (MSAs). Methods Patients with LSS and concordant neurogenic claudication treated with MSAs (n = 701) or conservatively without MSAs (n = 2104) at a single tertiary care hospital were identified. Patient QOL measures (Patient Health Questionnaire-9 [PHQ9], EuroQOL-5 Dimensions [EQ-5D], Pain Disability Questionnaire [PDQ]) were recorded pretreatment and then 4 months following treatment. Propensity score matching was used to account for baseline demographic differences between the two groups. The primary outcome measure was posttreatment improvement in these QOL measures. Results Patients in both groups had statistically significant improvements in the EQ-5D. However, the EQ-5D improvement in the MSA group was significantly greater than the improvement in the control group (0.11 versus 0.06; p = 0.0494). The EQ-5D change in the MSA group also exceeded the minimum clinically important difference, thereby suggesting a clinical significance. Both groups had significant pre- to posttreatment improvements in PDQ and PHQ-9, but these changes were not significantly different between the groups. Conclusion The results of this study suggest that patients with LSS and neurogenic claudication can have greater QOL improvements when treated with MSAs compared with other forms of conservative management without MSAs.
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