The effectiveness of Mindfulness based stress reduction in cancer patients
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer And Breast Cancer
PROVIDER: 2496134 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Intervention 1: In the pre-test, the questionnaire was provided to intervention group. After recognizing that the individuals in the intervention group were in the process of fear control of or threat control, educational content was delivered.Educational intervention content was provided to the intervention group to change that threat control and fear control with items to raise awareness of people about Colo-rectal cancer, risk factors and prevention and specially colonoscopy screening through lecture, pamphlets, booklets,film, posters, and text messages.Three months after the educational intervention in intervention group, post-test was repeated in intervention group . Intervention 2: Control group: In the pre-test, the questionnaire was provided to control group.Control group didn’t receive educational intervention .After three months the educational intervention in intervention group , post-test was repeated in control group. Finally, the educational content packages were also given to the control group.
Primary outcome(s): Colonoscopy from %10 to %30. Timepoint: Pre educational intervention , 3 months after intervention. Method of measurement: Researcher- made questionnaire based on construction of Extended Process Parallel Model , Kim Witte.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After selecting the eligible samples regarding the randomly assigned tables, the participants were divided into two groups of intervention and the control and the educational intervention was conducted in the intervention group.
| 2492986 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: First, the pre-test will be done. The experimental group will participate in 8 sessions of group therapy managed by the researcher and with the presence of psychologists. The content of sessions is designed and implemented Based on the Snyder’s work. Then, the post-test will be done and the results of the pre-test and the post-test will be compared. Intervention 2: Control group: This group will not receive any intervention. The difference of the quality of life, compliance of the pre-test and the post-test will be measured and compared with each other.;Intervention group: First, the pre-test will be done. The experimental group will participate in 8 sessions of group therapy managed by the researcher and with the presence of psychologists. The content of sessions is designed and implemented Based on the Snyder’s work. Then, the post-test will be done and the results of the pre-test and the post-test will be compared.;Control group: This group will not receive any intervention. The difference of the quality of life, compliance of the pre-test and the post-test will be measured and compared with each other.
Primary outcome(s): Hope. Timepoint: Before intervention, after intervention. Method of measurement: Snyder’s Hope Scale.;Quality of life. Timepoint: Before intervention, after intervention. Method of measurement: QLQ-C30 Persian.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Random assignment of subjects into two groups: First, subjects’ names will be written randomly on paper according to odd and even numbers. then the subjects will be randomly divided into two groups of experimental and control.
| 2488738 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Pre- and postoperative treatment by oral probiotic drug after colorectal surgery. Intervention 2: Control group: Routine pre- and postoperative treatment of colorectal surgery.
Primary outcome(s): Anastomosis rupture. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Surgical site infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Fascia dehiscence. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Pulmonary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Chest x-ray if clinically indicated.;Urinary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Urinalysis if clinically indicated.;Total duration of hospital stay. Timepoint: Daily. Method of measurement: Total duration of hospital stay till discharge.;Mortality. Timepoint: Daily. Method of measurement: Report of death by attending physician.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomized between two study (who will receive the probiotic) and control (who will not receive the probiotic) groups by the random numbers produced by the website: www.randomizer.org.
| 2482659 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test. Intervention 2: Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film. Intervention 3: Intervention group3: free access to fecal occult blood test. Intervention 4: Control group: For the control group will not perform any of the action that will be taken for the intervention group.;Prevention;Prevention;Prevention;Prevention;Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test;Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film;Intervention group3: free access to fecal occult blood test;Control group: For the control group will not perform any of the action that will be taken for the intervention group.
Primary outcome(s): Perceived severity. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Knowledge. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived susceptibility. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Intention. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived barriers. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Social support. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Self efficacy. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived benefits. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening.
| 2485950 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention 2: Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Primary outcome(s): The first day of defecation. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of flatus. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of oral feeding. Timepoint: daily up to one week. Method of measurement: stariting of oral diet based on surgeons decision.;Post operation early complications. Timepoint: daily up to one month. Method of measurement: question from the patient in daily ward visits.;Post operation late complications. Timepoint: monthly up to 6 months. Method of measurement: question from the patient in monthly clinic visits.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com, Blinding description: In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
| 2492823 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: The intervention is Polypill V, which includes aspirin (81 mg), valsartan (40 mg), atrostatin (20 mg) and hydrochlorothiazide (5.12 mg). This pill is produced Alborzl Company and is taken once a day after dinner. Intervention 2: Control group: patients are followed for cardiovascular events.
Primary outcome(s): Systolic and diastolic heart failure. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Symptomatic arrhythmia. Timepoint: 6 months and one year after the intervention. Method of measurement: Clinical symptoms, Ecocardiography.;Acute coronary syndromes. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Stroke. Timepoint: 6 months and one year after the intervention. Method of measurement: Brain CT scan.;Cardiovascular mortality. Timepoint: 6 months and one year after the intervention. Method of measurement: Death certificate.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified randomization is used for random allocation ofpatients. In breast cancer patients have three stratum : 1- The group that take anthracycline alone (60%) in which 78 people take drug and 78 people take usual care, 2- The group that take anthracycline and bevacizumab (20%) In this group, 26 people take drug and 26 people take usual care. 3 - The group that does not take anthracycline (20%) In this group, 26 people take drug and 26 people take usual care. In colon cancer patients have two stratum : 1 - Group that take chemotherapy (80%) In this group, 72 people take drug and 72 usual care. 2- Group that only undergoes surgery (20%) In this group, 18 people take drug and 18 people take usual care. Randomization is done using randomization software, the output of the software is from number 1 to 440, which indicates that each person who
| 2503026 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: acceptance and commitment therapy enriched with compassion, 10 weekly sessions. Intervention 2: Control group: receive no treatment.
Primary outcome(s): Body image. Timepoint: Before and after treatment (2 months interval). Method of measurement: Multi-dimensional questionnaire of individual’s attitude about body image.;Cognitive-behavioral avoidance. Timepoint: before and after treatment (2 months interval). Method of measurement: Young-Rygh Avoidance Inventory.;Sexual satisfaction. Timepoint: before and after treatment (2 months interval). Method of measurement: Hudson Sexual Satisfaction Scale.
Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.
| 2502309 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Nanocurcumin 40 mg capsule formulated by Exir Nanosina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Intervention 2: Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen.
Primary outcome(s): Metastatic extent. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography.;Assess CRP levels. Timepoint: At the beginning and after the end of three and six chemotherapy courses. Method of measurement: Blood test.;Assess CEA and CA19-9 levels. Timepoint: At the end of three courses and six courses of chemotherapy. Method of measurement: Blood test.;Radiographic response of the tumor. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo, Blinding description: Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Dat
| 2501499 | ecrin-mdr-crc
Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.
Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.
| 2484333 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group1: Coloanal End to End Anastomosis. Intervention 2: Intervention group 2: Side to End Anastomosis. Intervention 3: Intervention group 3: J poach coloanal anastomosis.
Primary outcome(s): Surgery period. Timepoint: onset to end of anesthesia. Method of measurement: Minute.;Hospital Stay. Timepoint: Discharge Time. Method of measurement: day.;Blood Loss. Timepoint: ?End of surgery. Method of measurement: CC.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization of individual by randomly drawing sealed envelopes, using a computer-based table of randomization by a surgical assistant, Blinding description: In this single-blind study, the participants were not familiar with three types of anastomosis surgery in this study. In addition, the observer, who completed the questionnaire, was not familiar with the groups. Similarly, the data analyzer did not know the study groups. However, the main researcher (surgeon) was informed about the groups, and all surgical procedures were performed by the same surgeon. The safety and data monitoring committee was also informed about the study groups.
| 2485057 | ecrin-mdr-crc