The family-based intervention program (FOCUS) designed to Support and cope for mastectomy patients undergoing chemotherapy and their families. The sampling method will be available at first. A total of 60 patients and an active members of the family will enroll. Inclusion criteria included: age 30-60 years, speak persian language, diagnosis breast cancer, having experienced a mastectomy procedures, pass 48 hours of chemotherapy, between two chemotherapy, do not having other cancer, do not having a history of hospitalization. Exclusion criteria: any stressful event for the patient or family members patient during the study and the absence of more than a session of meetings of family intervention. Patients will enter in the intervention and control groups. The intervention consisted of implementation the FOCUS program will be based family intervention. Intervention will happen in 6 sessions in format of the FOCUS program items. Participants will complete cancer coping questionnaire before and after intervention to assess the impact of the intervention program. Therefore aim of this study to determine that the effect of family intervention based on FOCUS program on cancer coping in breast cancer survivors undergoing chemotherapy in academic centers of Urmia in 2016.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052820778N16
Registration date:2016-07-11, 1395/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University Of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family intervention based on FOCUS program on cancer coping in breast cancer survivors undergoing chemotherapy
Public title
Effect of family-based intervention on cancer coping in breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: ages 30-60 years؛ speak the persian language؛ diagnosis breast cancer؛ having experienced a mastectomy procedures؛ pass 48 hours of chemotherapy؛ between two chemotherapy؛ do not having other cancer؛ do not having a history of hospitalization.
Exclusion criteria: any stressful event for the patient or family members during the study and the absence of more than one session of meetings.
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Based on odd or even being randomly 30 patients for control group ,and 30 patients for intervention group will select.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University Of Medical Sciences
Street address
Resalat Blv, next to the emergency center، Urmia University Of Medical Sciences
City
Urmia
Postal code
5714783734
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
Ir umsu.rec.1395.109
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50-C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Cancer coping
Timepoint
Before intervention and 6 weeks after the first session
Method of measurement
Cancer coping questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-centered group discussion and counseling that include six meetings of the group of patients and an active member of families that includes six groups and each group will have five families in the intervention group. With titles introduce, communicate and encourage clients to express their views on their experiences in applying methods of coping before, providing effective solutions and use and interpret and to discuss any of the agenda items FOCUS in each of the meetings.The duration of each session will be about 1.5-2 hours. Researcher will use tools such as flash card, PowerPoint, pamphlets, lectures and group discussion to more effective intervention program during the intervention. Researcher will use brainstorming ways to solve the problems. Researcher will give diary to the patients. Participants will encourage to do that practice in the home between two sessions and report to express their assignment procedure at each meeting. Meetings will be weekly for 6 weeks.The first session includes of support and family involvement, optimistic attitude to have a second meeting, the third session of the impact of the deal and cope with cancer, reduce uncertainties for fourth session and the fifth session will be symptoms management.
Category
Lifestyle
2
Description
Control group: The control group will not receive the any intervention. But due to ethical norms that they were in the control group, after the intervention, one or two sessions will do for them.