Participatory Colorectal Cancer Screening Programs
Ontology highlight
ABSTRACT:
DISEASE(S): The Prevention Of Colorectal Cancer
PROVIDER: 2491521 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Intervention 1: One group in the study will receive educational intervention. Educational content provided to the intervention group includes an app that is designed based on preventive health model, and an educational pamphlet about colorectal cancer, the importance of screening and a variety of colorectal cancer screening methods. Intervention 2: Control group: One group as a control group will enter the study, that will not receive any training and intervention.
Primary outcome(s): Perceived self-efficacy. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Perceived sensitivity. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Worries and fears. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Screening Effectiveness. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Social support. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Behavioral intention. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Screening, Randomization description: Samples were randomly selected from 2 centers by block sampling method and samples of both groups will be matched based on demographic variables such as age, education, and so on. Random assignment of selected individuals will be done by block random method using quad blocks. For two groups of intervention and comparison use two letters A and B. So the size of each block is twice the number of groups, that is, the number 4. By dividing the sample size by block size, the number of blocks is determined. Sample size is 160 people. Each group consists of 80 people, and the number of blocks in each group is 20 blocks, each of which specifies the assignment of 4 individuals. Finally, all letters A and B are separated, and each person who is not the researcher, by lot, will be suspended by each letter in a group. For example, A intervention group
| 2497407 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. The ketogenic diet is a low-carb, high-fat diet. The ratio of macronutrients in this diet: 75% fat, 15 to 20% protein, 5 to 10% carbohydrates. The nutritionist will explain to the patients about the diet, then the manuals of this diet will be provided to patients. Patients will be followed by telephone for diet compliance. Intervention 2: Control group: In the control group, only the standard chemotherapy protocol will be implemented for patients.
Primary outcome(s): Response to treatment including primary tumor and metastasis size before and after the intervention. Timepoint: Before and three months after the intervention. Method of measurement: With CT scan imaging in millimeters.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization method. According to the total sample size (42 patients), 7 blocks of size 6 will be considered. (A: intervention group and B: control group). So that the all possible combinations of AAABBB will be listed. Then each combination will be given a number of one to seven. A number will be selected randomly for determination of one of the possible combinations. The randomization process will be continued until the last combination is enrolled. Patients will be divided into two groups according to the order of selected blocks.
| 2504589 | ecrin-mdr-crc
Project description:Intervention 1: In the intervention group, the educational intervention was based on the model of health belief and needs assessment, which was done before the training and using valid books and educational booklets and the latest instructions issued by the Ministry of Health and appropriate to the level of literacy of learners and based on adult education. Health belief model structures will be prepared, developed and implemented. Intervention 2: Control group: The control group will receive routine training from health centers.
Primary outcome(s): Awareness. Timepoint: Before intervention and 1 month after educational intervention. Method of measurement: questionnaire.;Colorectal cancer screening behavior. Timepoint: Before intervention and 1 and 3 month after educational intervention. Method of measurement: questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, in addition to the constructs of the health belief model, behavioral intent and screening behavior are also investigated, Randomization description: Block Random Method will be used to assign eligible people to two groups. The size of the blocks is 4 and 6. Randomization will be done individually. In the Block Method, due to the use of different combinations in each block, it is not possible to predict the randomization sequence, so the concealment process will also be observed. For the guaranteed encryption process, the randomization files are generated in Excel and will remain close to the epidemiologist’s colleague, then the Epidemiologist will be contacted to allocate the eligible people to two groups, the sick person, and to position each person in the groups, will be decided according to the randomization sequ
| 2755483 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: they receive educational content in form of educational text messages (2 to 3 messages), audio messages, images and related videos (8 am to 8 pm daily) for one month through a virtual social network. After sending the messages, the participants are requested to send the sentence the message has been read to the researcher at the end of the day after reading the messages. In addition, to ensure the participants understanding of the concept of the sent educational content , at the end of each week, patients were asked 2 to 3 questions about the sent content. Intervention 2: Control group: They received the routine education of the hospital. After one month and after completing the questionnaires, the nutrition educational booklet was also provided to the control group.
Primary outcome(s): Nutritional status score with PG-SGA questionnaire. Timepoint: At the beginning of the study (before the intervention) and one month after the educational intervention. Method of measurement: Patient-Generated Subjective Global Assessment (PG-SGA).
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Recruiting was done when patients went to the hospital and clinic for chemotherapy. Then the samples were randomly divided into two groups of 40 people with random allocation in the intervention (A) and control (B) groups. At first, the blocks of four were defined as follows: ABAB, BBAA, BABA, BAAB, AABB , ABBA, etc. and were placed in the envelope and numbered. The blocks were determined using a table of random numbers, and people were placed in two intervention and control groups according to A and B. Patient A was placed in the supportive educational intervention group through virtual social networks and patient B was placed in the control group.
| 24650 | ecrin-mdr-crc
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: In this group, an intervention program is designed focusing on the components of the social Marketing Mix or 4P (product, price, place, promotion).This intervention program includes a set of communication, executive proceedings, educational and informational programs and Transfer effective messages through the preferred communication channels mentioned by the participants to reduce or eliminate barriers and create facilitators to perform the desired behavior, which is participation in fecal immunochemistry, is carried out for one month. To evaluate the effectiveness of the intervention program, three months and 6 months after the intervention, the level of participation in fecal immunochemistry is assessed and compared with the control group. Also, before the interventions and 3 months and 6 months after the interventions, refer to the experimental and control groups again and the champion questionnaire is completed and the mean score of health beliefs about colorectal cancer screening is determined and compared between the two groups. Intervention 2: Control group: In this group, any of the interventions of the intervention group is presented. If participation in this group recourse for a Fecal Immunochemistry test, the test will be done for them. At the end of the research, in order to comply with ethical issues, all the designed training materials will be provided to the control group.
Primary outcome(s): Colorectal Cancer Screening. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Participation rate in Fecal Immunochemistry Test.;Health Beliefs. Timepoint: 3 and 6 months after the intervention. Method of measurement: Champion’s Health Belief Scale.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Firstly, 200 samples with having inclusion criteria will be selected using a table of random numbers. Then, a random allocation software will be used to create 50 blocks with a block size of four. in order to create a list of block randomization, refer to following website is done:https://www.sealedenvelope.com/simple-randomiser/v1/lists. Then, based on this generated list (BABA, ABBA, BAAB, BABA, AABB, ...), the subjects will be allocated into the intervention (B) or control (A) groups, Blinding description: In order to perform blinding, assistant researcher who collects data before and after the intervention, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.
| 2482101 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow & et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 2: Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 3: Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment.
Primary outcome(s): Psychological distress. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Depression Anxiety and Stress Scale.;Meta-emotion beliefs. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Meta-Emotions Scale.;Acceptance. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Acceptance and Action Questionnaire.;Post-traumatic growth. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Post-traumatic Growth Questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: acceptance and commitment therapy, unified transdiagnostic treatment and control. First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = acceptance and commitment therapy, B = unified transdiagnostic treatment, and C = control group. In this study with three groups A, B and C, we create the following six groups and assign a number from 1 to 6 to each group: ABC-ACB-BAC-BCA-CAB-CBA, Then, using the table of random numbers, we contract that if the n
| 2501113 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Roy follow-up care model. Intervention 2: Control group: Chemotherapy and routine nursing and medical care that are applied on a daily basis, and does not receive a training program based on the Roy adaptation pattern.
Primary outcome(s): The severity of depression, anxiety and stress. Timepoint: First and 2 months after the intervention. Method of measurement: Roy review And recognition form and anxiety scale, depression, stress DASS-21.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Blocks randomization method was used to allocate individuals to groups, Blinding description: the allocation of patients to the groups was done by a nurse in the department that have no information about the treatment of A or B group. (Hiding random allocation and staying out of the intervention group).
| 2488886 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Patients receiving 25 mg of captopril tablets daily for six weeks. Intervention 2: Control group: A placebo recipient who looks similar to Captopril and contains flour once a day for 6 weeks.
Primary outcome(s): Hand and foot syndrome. Timepoint: Every 3 weeks. Method of measurement: Physical examination.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization of patients between the intervention and control groups is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2. Patients are divided into two groups according to the time of referral according to the list of the mentioned group until the end of sampling, Blinding description: This study is performed in double blinds and patients and researchers are unaware of the type of drug received. Drugs are prepared in coded form in similar packages and are provided to the executor for prescription to patients. Outcome assessment is also done by someone who is not in the study.
| 2480495 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group (family-centered empowerment model): The members will receive 3 to 5 sessions of education based on family-centered empowerment model, which covers four stages: awareness and cognition, self-efficacy, self-esteem, and evaluation. Education will be delivered in groups of 5 using group discussion. Intervention 2: Control group: The control group will not receive a specific educational intervention.
Primary outcome(s): Self-care ability. Timepoint: before the intervention, immediately after the intervention, and one month after the end of the intervention. Method of measurement: researcher-made self-care ability assessment questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants will be allocated into experimental and control groups using the table of random numbers.
| 2497141 | ecrin-mdr-crc