Investigating the impact of a comprehensive nurse support program on death anxiety and compliance with hormone therapy in women with breast cancer
Design
This randomized clinical trial study with parallel groups will be conducted on 70 patients with breast cancer referring to the breast clinic of Shahid Motahari Hospital of Shiraz University of Medical Sciences. Patients participating in the study will be divided into two groups using a table of random numbers.
Settings and conduct
Patients with breast cancer referred to the breast clinic of Shahid Motahari Hospital of Shiraz University of Medical Sciences will be included in the study. Patients participating in the study are randomly assigned to two groups using a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to the breast clinic of Shahid Motahari Clinic of Shiraz University of Medical Sciences in the past 5 years who have breast cancer and have completed the course of treatment (surgery-chemotherapy-radiotherapy) and at least 1 year has passed since the start of hormone therapy be and express consent to participate in the study.Exclusion criteria: It includes patients who have a history of participating in similar courses and do not respond to follow-up calls.
Intervention groups
Intervention group 6 sessions (small group of 5 to 7 people) face-to-face for 45-60 minutes (in breast clinic training classes) and non-face-to-face (the same program online and of course offline in Eta, Soroush and Instagram) comprehensive nurse support program receives. Control group: will receive their usual care (including regular medical visits and periodical follow-ups).
Main outcome variables
Death anxiety and compliance with hormone therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240120060738N1
Registration date:2024-01-28, 1402/11/08
Registration timing:prospective
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Mohsen Hojat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5426 0608
Email address
mohsenhojat.mh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of a comprehensive nurse support program on death anxiety and compliance with hormone therapy in women with breast cancer
Public title
Investigating the impact of a comprehensive nurse support program on death anxiety and compliance with hormone therapy in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with primary breast cancer
Completing the course of surgery, chemotherapy and radiotherapy
be under hormone therapy (any hormone medication) for at least one year
In the last six months, she did not undergo any intervention regarding medication compliance or anxiety reduction
Access to a mobile phone and the ability to use it
Ability to perform physical activity
Exclusion criteria:
Failure to respond to follow-up calls or unwillingness to continue studying
Discontinuation of medication due to side effects
Recurrence of the disease in one of the organs
Severe crisis in life
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Generation of random numbers from the table of random numbers: Considering that 70 patients are needed in this study, a number was randomly selected from the table of random numbers and the digit on the right side of it was taken into account. If this digit was an even number, the patient was assigned to intervention group A. And if it was an individual, it will be assigned to control group B. For example, if the number 63 is selected in the table of random numbers, since 63 is an odd number, the first sample will be assigned to the control group. Allocation of people into two groups is determined.
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
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences , the end of Ostad Motahari Boulevard
City
Jahram
Province
Fars
Postal code
7414846199
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.JUMS.REC.1402.108
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Adherence to drug treatment
Timepoint
Before and after the intervention
Method of measurement
Questionnaire of compliance with Moriski's drug treatment
2
Description
anxiety
Timepoint
Before and after the intervention
Method of measurement
Templer Death Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group 6 sessions (small group of 5 to 7 people) face-to-face for 45 to 60 minutes (in the training classes of the Breast Clinic) and non-face-to-face (the same program online and of course offline in Ita, Soroush and Instagram) program Jame receives support from the nurse.
Category
Other
2
Description
Control group: will receive their usual care (including regular medical visits and periodical follow-ups).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Breast Clinic, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mani Ramzi
Street address
Motahari Clinic, next to Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
Email
pshora2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Solh joo Cavus
Street address
Jahrom University of Medical Sciences , the end of Ostad Motahari Boulevard,Jahrom
City
Jahram
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
pshora2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojjat
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom University of Medical Sciences,the end of Ostad Motahari Boulevard,Jahrom
City
Jahram
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
mohsenhojat.mh@gmai.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojjat
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom University of Medical Sciences, the end of Ostad Motahari Boulevard,Jahrom
City
Jahram
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
mohsenhojat.mh@gmai.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Saeede Raisi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahrom University of Medical Sciences , the end of Ostad Motahari Boulevard,Jahrom
City
Jahram
Province
Fars
Postal code
7414846199
Phone
0715433608
Email
saedehraiese@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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