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Investigation the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy surgery of breast cancer patients

Protocol summary

Study aim
Determining the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy in patients with breast cancer.
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized using a block method, phase three on 102 patients. Time block method is used for randomization.
Settings and conduct
This study will be conducted on breast cancer patients after radical mastectomy who are referred to Omid and Imam Reza hospitals in Mashhad. The intervention will include six weekly multimodal training sessions by nurses over a period of six weeks. During these sessions, education will be provided on nutrition, lymphedema prevention exercises, and psychological and social support.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with breast cancer, radical mastectomy surgery, two days to three months after mastectomy surgery, no diagnosis of lymphedema, age between 18 and 60 years, and willingness to participate in the study. Exclusion criteria: non-participation in one or more nursing training sessions, presence of upper limb musculoskeletal disorders and upper limb infection or wound, initiation of chemotherapy and radiotherapy treatment, failure to complete research questionnaires, and withdrawal from the study.
Intervention groups
The intervention includes the implementation of multimodal educational sessions by the nurse for six sessions will be carried out on a weekly basis during six weeks. At the same time as the intervention group, the control group receives routine training programs of the hospital, which are taught in the health clinic of Omid and Imam Reza hospitals.
Main outcome variables
The amount of lymphedema and self-efficacy after mastectomy surgery of patients with breast cancer before the intervention, immediately after its completion and after two weeks the end of the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241221064120N1
Registration date: 2025-03-12, 1403/12/22
Registration timing: prospective

Last update: 2025-03-12, 1403/12/22
Update count: 0
Registration date
2025-03-12, 1403/12/22
Registrant information
Name
Elahe Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3726 1230
Email address
safariel3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy surgery of breast cancer patients
Public title
Investigation the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy surgery of breast cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer diagnosis Age between 18 and 60 years Having radical mastectomy surgery Two days to three months passed after surgery No diagnosis of lymphedema Willingness to participate in the study
Exclusion criteria:
Failure to participate in one or more nursing training program sessions Musculoskeletal disorders of the upper limbs Having an infection or wound of the upper limbs Start chemotherapy and radiotherapy treatment Failure to complete research questionnaires Announcing withdrawal from the research
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided into 2 groups using the time block of 34 people randomly allocated using the Sealed envelope website and the groups are named A and B respectively, so that A group will receive multimodal training and B group will receive routine hospital training. The benefit of this method is that the volume of each block must be determined based on the time of visiting the hospital (block of three). Then the list of blocks is written and numbers are assigned to them, then random numbers between 1 to 6 (for example, 1, 4, 5, etc.) are selected and the numbers are placed in sealed envelopes, and people randomly pick the envelopes and continue until the final sample size is reached.(Odd numbers include the intervention group and even numbers include 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 Mashhad University of Medical Sciences
Street address
Deputy for Research and Technology, Qorashi Building, next to Hoveyzeh Cinema, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Approval date
2025-01-21, 1403/11/02
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.086

Health conditions studied

1

Description of health condition studied
Lymphedema after Mastectomy in breast cancer
ICD-10 code
I97.2
ICD-10 code description
Postmastectomy lymphedema

Primary outcomes

1

Description
The extent of lymphedema after mastectomy in patients with breast cancer
Timepoint
before the start of the intervention, immediately after its completion (primary) and after two weeks after the end of the intervention (secondary)
Method of measurement
Q-DASH (standardized Q-DASH) and arm circumference measurement method (by measuring 10 cm above the wrist and 10 cm above the elbow of both limbs and the difference in arm circumference of the two limbs is more than 2 cm)

2

Description
The level of self-efficacy after mastectomy surgery of patients with breast cancer
Timepoint
before the start of the intervention, immediately after its completion (primary) and after two weeks after the end of the intervention (secondary)
Method of measurement
Chronic Disease Self-Efficacy Questionnaire (CDSES)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with breast cancer after radical mastectomy referred to Omid and Imam Reza teaching hospitals in Mashhad. Intervention: multifaceted nursing training sessions (physical, psychological and social) in six one-hour sessions over six weeks
Category
Prevention

2

Description
Control group: breast cancer patients after radical mastectomy referred to teaching hospitals in Mashhad, who receive the hospital's routine educational content regarding lymphedema and improving self-efficacy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Elahe Safari
Street address
Omid Hospital, AlNandasht Square, Kohsangi St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 51 3726 1230
Email
safariel3@mums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Elahe Safari
Street address
Imam Reza Hospital, Imam Reza Square, Ibn Sina Street., Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 51 3726 1230
Email
safariel3@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbas Heidary
Street address
Mashhad University of Medical Sciences, Olom blvd, Pardis, Vakil abad blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 915 320 7388
Email
HeidaryA@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Safari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block 52, Shahid Karimi 4,6 Ave, Shahid Karimi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 51 3726 1230
Email
safariel3@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Safari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block 52, Shahid Karimi 4,6 Ave, Shahid Karimi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 51 3726 1230
Email
safariel3@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Safari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block 52, Shahid Karimi 4,6 Ave, Shahid Karimi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687367
Phone
+98 51 3726 1230
Email
safariel3@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data includes age and gender, the incidence of lymphedema, and the self-efficacy of the intervention group and the control group.
When the data will become available and for how long
The access period starts six months after the publication of the results
To whom data/document is available
People working in academic and scientific institutions as well as people working in industry
Under which criteria data/document could be used
People who need data for research and scientific work.
From where data/document is obtainable
Elahe safari safariel3@mums.ac.ir
What processes are involved for a request to access data/document
First, they will email me the request and the reason for it, and then after checking and confirming her reasons, the data will be emailed to her.
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