Protocol summary

Study aim
The general objective of this study is to develop, implement, and evaluate the effect of Coping Skill Education Intervention on the coping strategy and quality of life among primary caregiver for women with breast cancer in Jordan.
Design
Cluster Randomized Control Trial
Settings and conduct
Jordanian MOH hospitals
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Primary caregiver of age 18 years or older. 2. Able to read and write in Arabic language. 3. Primary caregiver who provides care and living together with the woman with breast cancer at least for 6 months before the study. Exclusion criteria 1. Caregivers professionally trained or work as health care provider. 2. Caregivers who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, psychoeducational intervention).
Intervention groups
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.
Main outcome variables
Quality of life and coping strategy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200708048056N1
Registration date: 2020-07-26, 1399/05/05
Registration timing: prospective

Last update: 2020-07-26, 1399/05/05
Update count: 0
Registration date
2020-07-26, 1399/05/05
Registrant information
Name
Jawad Obaidi
Name of organization / entity
Universiti Putra Malaysia
Country
Jordan
Phone
+962 2 656 0132
Email address
jobaidi85@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-02, 1399/05/12
Expected recruitment end date
2020-11-22, 1399/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Coping Strategy Educational Intervention on Quality of Life and coping strategy among Primary Caregiver of Jordanian Women with Breast Cancer
Public title
Effect of Coping Strategy Educational Intervention on Quality of Life and coping strategy among Primary Caregiver of Jordanian Women with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Caregivers professionally trained or work as health care provider. Caregivers who previously participated in the intervention research (e.g, Cognitive Behavior Therapy, psychoeducational intervention).
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Cluster Randomized Control Trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ETHIC COMMITTEE FOR RESEARCH INVOLVING HUMAN SUBJECT
Street address
43400
City
Serdang
Postal code
603
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
UPM/TNCPI/RMC/1.4.18.2(JKEUPM)

Health conditions studied

1

Description of health condition studied
Breast cancer caregiver quality of life and coping
ICD-10 code
ICD-10 code description
quality of life

Primary outcomes

1

Description
Quality of life
Timepoint
Before and after intervention and 4 weeks after intervention
Method of measurement
Questionnaire

2

Description
Coping
Timepoint
Before and after intervention and 4 weeks after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Demographical
Timepoint
before the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
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)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Jordanian Minestry of health
Full name of responsible person
Saad Jaber
Street address
Amman, northren hashmi
City
Amman
Postal code
06
Phone
+962 6 520 0230
Email
diwan@moh.gov.jo

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Self Finance
Full name of responsible person
Jawad Ghaleb Said Obaidi
Street address
Howarrah-farabi 15
City
Howarrah
Postal code
0962
Phone
+962 2 656 0132
Email
jobaidi85@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Finance
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Jawad Ghaleb Obaidi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Howarah,Farabi street 15
City
Howarah
Province
Irbid
Postal code
02
Phone
0096279858865
Email
jobaidi85@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Lee Khuan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Serdang, 43400
City
Selangor
Province
Serdang
Postal code
03
Phone
+60 3-9769 1002
Email
leekhuan@upm.edu.my

Person responsible for updating data

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Jawad Ghaleb Obaidi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Howara.Farabi street15
City
Howarah
Province
Irbid
Postal code
02
Phone
+962 7 9285 8865
Email
jobaidi85@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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