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The effect of an online occupation-based intervention program on arm lymphedema, spirituality, occupational performance, sexuality function and adaptive response in women with breast cancer

Protocol summary

Study aim
The effect of an online and occupation-based intervention program on arm lymphedema, spirituality, occupational function, sexual function and adaptive response in women with breast cancer
Design
A single-blind randomized controlled clinical trial study
Settings and conduct
Lymphatic rehabilitation centers in Tehran and Ahvaz and 40 participants will be divided into two groups of intervention and control by Stratified Balanced Block Randomization with equal block method. Out of a maximum of 20 modes for the six blocks, three will be in the intervention group or A and three in the control group will be created using the RANDBETWEEN (1,20) command in Excel software. Participants will be divided equally into two groups according to the random sequence created.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to verbally communicate and speak in Persian, read and write, Being over 18 years of age, having access to a telephone,, Get a score above 22 on the MMSE cognitive test, Histologically confirmed malignancy based on the physician's diagnosis. Exclusion criteria: people with brain metastases, mental disabilities, psychosis and dementia.
Intervention groups
Intervention group: Combined program including lymphatic therapy (CDT) and an individual, remote (telephone and available applications) and occupation-based treatment during 10 weeks based on the Occupational Adaptation Practice Guideline (OAPG) during a 5-week intervention program and during 10 sessions. Control group: Complete decongestive therapy (CDT) for ten sessions one hour sessions within 5 weeks in lymph therapy clinics.
Main outcome variables
Canadian Occupational Performance Measurement Relative Mastery Scale the 12-item Spiritual Well-being scale The Persian version of the Lymphedema Life Impact Scale (LLIS) The Female Sexual Function Index (FSFI)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211220053459N2
Registration date: 2023-03-07, 1401/12/16
Registration timing: registered_while_recruiting

Last update: 2023-03-07, 1401/12/16
Update count: 0
Registration date
2023-03-07, 1401/12/16
Registrant information
Name
Fatemeh Motaharinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
fatemeh.motahari64@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an online occupation-based intervention program on arm lymphedema, spirituality, occupational performance, sexuality function and adaptive response in women with breast cancer
Public title
The effect of occupational therapy in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to verbally communicate and speak in Persian Read and write Being over 18 years of age Having access to a telephone Get a score above 22 on the MMSE cognitive test Histologically confirmed malignancy based on the physician's diagnosis
Exclusion criteria:
People with brain metastases Mental disabilities Psychosis Dementia
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
50 participants will be divided into two groups of intervention and control by Stratified Balanced Block Randomization with equal block method. Out of a maximum of 20 modes for the six blocks, three will be in the intervention group or A and three in the control group will be created using the RANDBETWEEN (1,20) command in Excel software. Participants will be divided equally into two groups according to the random sequence created.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
سمنان بلوار بسیج ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان سمنان
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.SEMUMS.REC.1401.260

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
level of occupational performance and satisfaction of occupational performance
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Canadian Occupational Performance Measurement

2

Description
Adaptation
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Relative Mastery Scale

Secondary outcomes

1

Description
Spirituality
Timepoint
En Before the intervention, after the intervention and one month after the intervention
Method of measurement
the 12-item Spiritual Well-being scale

2

Description
Lymphedema
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
The Persian version of the Lymphedema Life Impact Scale (LLIS)

3

Description
Sexual Function
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
The Female Sexual Function Index (FSFI)

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive a combined program including lymphatic therapy (CDT) and an individual, remote (telephone and available applications) and occupation-based treatment during 10 weeks. Occupation-based treatment will be based on Occupational Adaptation Practice Guideline (OAPG) during a 5-week intervention program and during 10 sessions (two sessions of 40 minutes each week). Based on this guideline, the interaction between personal characteristics (physical, motor, cognitive, psychological skills, etc.) with environmental subsystems (characteristics of the physical, social environment, etc.) of the participant will examine and provide specific occupational therapy interventions for each participant to facilitate this interaction and to help for better adaptation with the existing conditions.
Category
Rehabilitation

2

Description
Control group: Complete decongestive therapy (CDT) for ten sessions one hour sessions within 5 weeks in lymph therapy clinics. Complete decongestive therapy (CDT) is a noninvasive treatment for lymphedema. The key components of a CDT program are: Manual lymphatic drainage (MLD), Compression, Regular Exercises and Skin care.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Lymphatic rehabilitation centers
Full name of responsible person
Fatemeh Motaharinezhad
Street address
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514645719
Phone
+98 23 3332 2035
Email
fatemeh.motahari64@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Majid Mirmohammadkhani
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Motaharinezhad
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514645719
Phone
+98 23 3332 2035
Email
fatemeh.motahari64@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Motaharinezhad
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514617121
Phone
0233328357
Email
fatemeh.motahari64@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Motaharinezhad
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514617121
Phone
0233328357
Email
fatemeh.motahari64@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document
.
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