Determining and comparing the effectiveness of the nurse navigator program on reducing care needs in the treatment of breast cancer patients in the control and intervention groups
The effect of the nurse navigator program on satisfaction with breast cancer related care in the intervention group
Design
The present study is a clinical trial with an intervention and control group, which is performed using random block allocation on 60 patients.
Settings and conduct
The present study is conducted on patients with positive pathology of breast cancer who refer to the cancer research center of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Women referring to the Cancer Research Center with positive breast cancer pathology are screened for inclusion criteria at their first physician visit. Inclusion criteria included: women over 18 years of age, no previous history of cancer, no dementia, and access to telephone and internet.
Intervention groups
The care program provided by the nurse navigator includes a support package (educational and psycho-emotional) as well as telephone and online follow-up. The support package includes education related to the nature of cancer, types of treatment and complications, and how to manage complications. Psychological support includes talking to the patient and teaching stress reduction techniques based on mindfulness. At least two phone calls are made until the end of the surgery.
Main outcome variables
Supportive care needs of patients, satisfaction with cancer-related care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240610062078N1
Registration date:2024-06-17, 1403/03/28
Registration timing:prospective
Last update:2024-06-17, 1403/03/28
Update count:0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
Mahboubeh Sadat Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
msyousefi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of Nurse Navigator Program (NNP) for Patients with Breast Cancer
Public title
effect of nurse navigator program in breast cancer care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive breast cancer pathology who have referred to the Cancer Research Center.
Willingness to participate in the study.
Patients who are over 18 years old.
Patients who have no previous history of cancer.
Patients who do not have dementia.
Patients who do not have advanced breast cancer.
Have access to telephone and internet.
Exclusion criteria:
Age
From 18 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
In order to balance the number of samples allocated to each of the study groups, the block randomization method is used. According to the final sample size in this study, 10 blocks of 6 are used to allocate the participants in each group, and the intervention and control groups will be randomly assigned to the letters A and B according to the predetermined blocks. People are divided into two intervention and control groups according to the inclusion criteria for the study and according to randomly designed blocks (in each block, 3 people for the intervention group and 3 people for the control group).
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 Shahid Beheshti University of Medical Sciences
The mean of supportive care needs in the care needs survey questionnaire
Timepoint
Before and after the intervention
Method of measurement
supportive care needs survey
Secondary outcomes
1
Description
patient satisfaction related to cancer care
Timepoint
After the intervention
Method of measurement
The item was scored on a 10-point scale (response options ranged from 1 = Not at all to 10 = Very satisfied).
Intervention groups
1
Description
Intervention group: It includes a support package, telephone follow-up and online follow-up. The support package includes education related to breast cancer, types of treatment and side effects of treatments, types of surgery, side effects of surgery and post-surgery care. Also, psycho-emotional care includes listening to the patient's words and stress reduction techniques based on mindfulness. These items are sent in the form of educational videos on virtual networks. In addition, telephone follow-up is done for timely treatment.
Category
Other
2
Description
Control group: Patients in the control group do not receive the services of a nurse navigator and only receive routine medical care as determined by the center.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center, Shahid Beheshti University of Medical Sciences,