1) Objectives: Determine the effectiveness of health literacy group consultation on self-care in women with breast cancer(2) Design: It is a randomized trial without blinding.(3) Setting and conduct: Shiraz center (4) Participants: the sample consisted of 64 women with breast cancer who have had a mastectomy. inclusion criteria is: being Iranian women with breast cancer who have had a mastectomy, the first meeting of chemotherapy, no other underlying disease, wanting to take part in the study and exclusion criteria is: no wanting to take part in the study, lack of participation in a maximum of two sessions of consultation, failure to complete or partially completed questionnaires. (5) Intervention: self care consultations. (6) Main outcome: the primary outcome variable is health literacy and second is self care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022327728N5
Registration date:2017-05-13, 1396/02/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-13, 1396/02/23
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of health literacy group consultation on self care in women with breast cancer
Public title
The effectiveness of health literacy group consultation on selfcare in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women; women with breast cancer who have had a mastectomy; the first meeting of chemotherapy; no other underlying disease; wanting to take part in the study.
Exclusion criteria: no wanting to take part in the study; lack of participation in a maximum of two sessions of consultations; failure to complete or partially completed questionnaires.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University Of Medical Sciences.
Street address
ninth floor, Dara building, north Yasmin, east Pune street, 45 Yards of Golshahr, karaj, Iran.
City
karaj
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
Abzums.Rec.1395.144
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
Health literacy.
Timepoint
At the beginning of the first session, at the end of sessions, three weeks after the intervention
Method of measurement
Iranian Health literacy Inventory
Secondary outcomes
1
Description
selfcare
Timepoint
At the beginning of the first session, at the end of sessions, three weeks after the intervention
Method of measurement
self care Inventory
Intervention groups
1
Description
1-Intervention group: In this group addition to routine counseling, Consultation with health literacy approach in self-care will offer in sessions. The number of sessions 7 and the duration of each sessions is an hour and a half the content that will be presented in each session is : session I: meet members and leaders of groups, create positive relationships،Expression rules of the group and motivate active participation and time attendance at meetings ،a description of the nature of the disease and chemotherapy, feeling of sickness،Perceptions of the disease affect the body, and the importance of self-care needs of patients in their care. Session 2: Advice on health related concepts, understand basic information and familiarity with the person's thinking in the field of health care, digestive problems and ways of dealing with it. Session 3: Understand basic information and familiarity with the person's thinking in the field of skin and hair health, ways of dealing with it. Session 4: understand basic information and a familiar with the person's thinking in the field of fatigue, shortness of breath, pain, sexual problems and the proposed solutions to reduce complications. Session 5: Meeting the basic knowledge and a familiar with the person's thinking In the field of Mental Health (stress, depression) ،symptoms and consequences، the need to identify, Prevention ways and ways of dealing with it Understanding concepts related to communication skills, understand the impact of family and social support. Session 6: understand basic information and a familiar with the person's thinking in the field of complications of treatments, the need to identify, prevent ways and the ways of dealing with it, and familiarity with the service provider associated with breast cancer. Session 7: Summary of presentations, training in counseling skills, ask questions about the classes held .receive feedback.
Category
Prevention
2
Description
2-Control group: In this group routine counseling sessions and self-care training package offered to control group.