Evaluation the effectiveness of a group psychoeducational intervention in reducing the level of cancer-related fatigue in women receiving chemotherapy for breast cancer: A randomized controlled Trial
Evaluate the effectiveness of a group psychoeducational intervention in reducing the level of cancer related fatigue in women receiving chemotherapy for breast cancer
Design
a randomized, parallel, single blinded, controlled clinical trial on 42 patient
Settings and conduct
the study had been performed in Isfahan Seyedoshohada hospital and patient didn' t know about which educational group had been enrolled
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definite diagnosis of breast cancer for at least 2 month ago, Under outpatient chemotherapy, Age between 18 to 60, Having a hemoglobin of 11 or more, Have reading and writing skills, Lack of metastasis, Lack of any chronic cardiac and respiratory disease and diabetes and absence of severe bone pain and balance problem
Exclusion criteria:
Acute respiratory, cardiac or infectious disease, reduce hemoglobin below 11، patient death
Intervention groups
In intervention group we used a self designed educational package consist of sleep health, energy management and concentration body movement therapy in three, forty minutes weekly sessions; in control group some general information about feeding, how to deal with hair loss and lymph edema, stress management and … had been educated.
Main outcome variables
decreased fatigue in interventin group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040193N2
Registration date:2018-08-12, 1397/05/21
Registration timing:retrospective
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Elham Zarean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
e.zarean@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-05-10, 1397/02/20
Trial completion date
empty
Scientific title
Evaluation the effectiveness of a group psychoeducational intervention in reducing the level of cancer-related fatigue in women receiving chemotherapy for breast cancer: A randomized controlled Trial
Public title
effectiveness of a group psychoeducational intervention in reducing the level of cancer-related fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of breast cancer for at least 2 month ago
Under outpatient chemotherapy
Age 18-60 years old
Having a hemoglobin of 11 or more
Have reading and writing skills
Lack of metastasis
Lack of any chronic cardiac and respiratory disease and diabetes and absence of severe bone pain and balance problem
Informed consent
Exclusion criteria:
acute respiratory, cardiac or infectious disease
reduce hemoglobin below 11
any mental or physical state that interfere participating in group intervention
patient death
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
42
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Patient were randomly allocated to either intervention or controlled group using random number generator software
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant are blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
. Ethics committee of SHahrekord University of Medical Sciences
Street address
Kashani Ave,SHahrekord university of medical science
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.SKUMS.REC.1396.247
Health conditions studied
1
Description of health condition studied
breast cancer, fatigue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fatigue
Timepoint
before intervention, immediately after end of intervention, 2 and 4 weeks later
Method of measurement
Fatigue Visual Analogue Scale, cancer fatigue scale, Piper Fatigue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We used a self designed educational package consist of sleep health, energy management and concentration body movement therapy in three, forty minutes weekly sessions.
Category
Treatment - Other
2
Description
Control group: three, 45 minutes weekly session about feeding, how to deal with lymph edema and hair loss, stress management and how to deal with children, spouse and family, how to access self help groups and supportive centers and external prosthesis