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IRCT20200708048056N1 IRCT 2020-07-26 Self Finance Effect of Coping Strategy Educational Intervention on Quality of Life and coping strategy among Primary Caregiver of Jordanian Women with Breast Cancer Effect of Coping Strategy Educational Intervention on Quality of Life and coping strategy among Primary Caregiver of Jordanian Women with Breast Cancer 2020-08-02 anticipated 124 Complete https://irct.ir/trial/49584 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Cluster Randomized Control Trial, Randomization description: In Jordan, there are different types of hospitals that classified as military, public, private and specialized hospitals. Unfortunately, all of this hospitals provided healthcare services in different policies and guidelines except the public hospitals. There are 32 governmental and universities hospitals cover all cities, taking into account that there are at least one or two hospitals in each city. Due to the type of sample and the population density, hospitals in Amman, in Al-Zarqa, and Irbid will be selected for this study. These hospitals are consider adequate to obtain the estimated sample size for this study. A. In the first stage: a list for all governmental hospital was done. According to the following eligible criteria four hospital will be selected: first, provide service for breast cancer patient. Second one, following Jordanian ministry of health policy. These four hospitals will randomly allocated for intervention and control group. B. In the second stage: all the eligible participant in the four hospitals will be identified and selected to participate in this study according to the inclusion and exclusion criteria to reduce the selection and consent bias. Randomization will be taken by using random sequence number generation to randomize in level of hospitals by following consort 2010 guidelines. A list will be done for all eligible hospitals. The hospitals will be allocated equally to the intervention or control group (1:1). The four hospital will take sequentially number (1-4). An independent researcher (Jordanian external supervisor) who will be asked to carry out the randomization procedure. The odd number (1 and 3) will be taken as the intervention hospitals and the even numbers (2 and 4) will be taken as the control hospitals by using random sequence number generation. After the completion of baseline collecting data, the researcher will check the questionnaire if completed by all recruited primary caregiver. The researcher will set number for the corresponding from (1 to 124). An independent researcher (external supervisor) who assigned for this study to avoid selection bias will provide a list of equal groups for all cluster. Each group contains 6-8 participants. Allocation Concealment The allocation concealment will be based on hospitals and individual level. The cluster allocation list will concealed from those involved in the research and place the numbers in sealed, opaque envelopes until the start of the intervention. Individual groups list for both arm of the study made by external supervisor will be concealed in sealed, opaque envelopes before one week of begging of the intervention each group will be contacted by hospital staff. Implementation The next step of randomization will be conducted by hospital administrator, someone who is not involved in all previous steps will open the sealed envelope and contact the four hospitals staff to inform the participants about their group time, and prepare them for first session, Blinding description: Single blind, the principle investigator the only person know the allocation of participants. The research assistances that will perform the outcome assessment will be blind to group allocation of the primary caregiver. The benefits of this step will be explained to researcher assistances and they will be instructed not to ask the primary caregivers about their allocations, and the primary caregivers will be instructed not to discuss their study treatment with anyone. The CSEI will be performed and be held in separate room. Different team of data collectors will be hired for all study sitting. 3 Breast cancer caregiver quality of life and coping. This section discusses the four-session training program, which will be presented to the intervention group, which will be lasted for 1 day for each group. The training will be conducted in the hall of the Oncology Unit of the hospital and will be coordinated by the research assistants. Participants will be randomly assigned to the experimental group and the control group. Both coping skill training programs and non-communicable disease (NCD) education will be performed in the experimental group, and only NCD education will be performed in the control group at the same consequences for experimental group. This design is more ethical and close to practical reality, as patients with breast cancer will all be provided with usual care mostly at their visit to the hospitals. The coping strategy training education consists of four sessions a day and will be performed only in the experimental group. Three health professionals will act as facilitators. They will receive 1-day training with detailed guidance of the study protocol. Researcher will provide coaching on caregivers’ responses to diverse situations to enable caregivers learn more skillful responses within four sessions. All caregivers will be encouraged by interventionists to practice the specific coping strategy at home after sessions end by regular phone calls. The primary goals of the coping skill educational program are: 1) to teach caregivers a variety of coping strategies; and, 2) to help the caregiver acquire and maintain positive coping strategy. The themes were: (1) introduction of Breast Cancer (BC) and importance of caregiver, (2) coping strategy (problem-focused strategy), (3) coping strategy (emotion-focused strategy) and (4) quality of life. Methods Teaching strategies are based on three components: 1-Audio-Visual: this strategy will provide the education module using a video comprising audio and visual contents. 2. PowerPoint presentations, markers, board, flip charts, projector, computer, and training guide. 3. Group discussion. each session will include 6 participants First session 9:00 AM - 10:10 AM (70 Min) break 10-10:20AM (10Min) Second session10:20 AM -11:20 AM (60 Min)Break 11:20 AM-11:30AM (10Min)Third session 11:30 AM- 12:20PM (50 Min)Break 120:20 PM - 01:00PM (40 Min)Fourth session 01:00 PM - 02:00 PM (60 Min). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Jawad Ghaleb Obaidi
Howarah,Farabi street 15
Howarah Jordan 02 0096279858865 jobaidi85@gmail.com Universiti Putra Malaysia scientific Lee Khuan
Serdang, 43400
Selangor Malaysia 03 +60 3-9769 1002 leekhuan@upm.edu.my Universiti Putra Malaysia Jordan Primary caregiver of age 18 years or older. Able to read and write in Arabic language. Primary caregiver who provides care and living together with the woman with breast cancer at least for 6 months before the study. 18 years no limit Both Caregivers professionally trained or work as health care provider. Caregivers who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, psychoeducational intervention). quality of life Lifestyle This section discusses the four-session training program, which will be presented to the intervention group, which will be lasted for 1 day for each group. The training will be conducted in the hall of the Oncology Unit of the hospital and will be coordinated by the research assistants. Participants will be randomly assigned to the experimental group and the control group. Both coping skill training programs and non-communicable disease (NCD) education will be performed in the experimental group, and only NCD education will be performed in the control group at the same consequences for experimental group. This design is more ethical and close to practical reality, as patients with breast cancer will all be provided with usual care mostly at their visit to the hospitals. The coping strategy training education consists of four sessions a day and will be performed only in the experimental group. Three health professionals will act as facilitators. They will receive 1-day training with detailed guidance of the study protocol. Researcher will provide coaching on caregivers’ responses to diverse situations to enable caregivers learn more skillful responses within four sessions. All caregivers will be encouraged by interventionists to practice the specific coping strategy at home after sessions end by regular phone calls. The primary goals of the coping skill educational program are: 1) to teach caregivers a variety of coping strategies; and, 2) to help the caregiver acquire and maintain positive coping strategy. The themes were: (1) introduction of Breast Cancer (BC) and importance of caregiver, (2) coping strategy (problem-focused strategy), (3) coping strategy (emotion-focused strategy) and (4) quality of life. Methods Teaching strategies are based on three components: 1-Audio-Visual: this strategy will provide the education module using a video comprising audio and visual contents. 2. PowerPoint presentations, markers, board, flip charts, projector, computer, and training guide. 3. Group discussion. each session will include 6 participants First session 9:00 AM - 10:10 AM (70 Min) break 10-10:20AM (10Min) Second session10:20 AM -11:20 AM (60 Min)Break 11:20 AM-11:30AM (10Min)Third session 11:30 AM- 12:20PM (50 Min)Break 120:20 PM - 01:00PM (40 Min)Fourth session 01:00 PM - 02:00 PM (60 Min) Quality of life. Timepoint: Before and after intervention and 4 weeks after intervention. Method of measurement: Questionnaire. Coping. Timepoint: Before and after intervention and 4 weeks after intervention. Method of measurement: Questionnaire. Demographical. Timepoint: before the intervention. Method of measurement: Questionnaire. Self Finance Approved 2019-11-23 ETHIC COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECT 43400 Serdang Selangor Malaysia