Determining the effect of a combined exercise program on sleep quality and fatigue severity in breast cancer patients undergoing chemotherapy
Design
A clinical trial with a control group, with parallel, randomized groups, on 64 patients, used a random number table for randomization.
Settings and conduct
Sports intervention will be performed on breast cancer patients undergoing chemotherapy referred to Seyed Al-Shohada Hospital in Isfahan. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients should be aware of their diagnosis;
The patient has the ability to speak and communicate verbally;
Cancer patients who have been diagnosed for at least one month;
Have had at least two sessions of chemotherapy.
Exclusion criteria:
Active mental illness and the use of drugs related to active mental illness;
Having any registered metastases;
Treatment with anticoagulants;
Radiotherapy before chemotherapy.
Intervention groups
In the intervention group: Sports intervention will be done during eight weeks in three sessions per week and each session will last 35 to 40 minutes. In this study, exercise protocol in a structured way and at home will include three parts: warm-up, aerobic exercise and cooling. On the first day, the prepared package will include the required sports equipment, a CD containing training videos of sports movements, an illustrated training booklet and an internet package with a volume of five gigabytes. On the day of delivery of equipment, all sports movements are taught to patients by the researcher.
In the control group, routine care is performed and the questionnaires will be completed by sending the questionnaire link via SMS (online) and in case of no internet access, by telephone.
Main outcome variables
sleep quality; Intensity of fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N1
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2021-12-22, 1400/10/01
Update count:0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a combined exercise program on sleep quality and severity of fatigue in breast cancer patients undergoing chemotherapy
Public title
Investigating the effect of a combined exercise program on sleep quality and severity of fatigue in breast cancer patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be aware of their diagnosis.
The patient has the ability to speak and communicate verbally. (Familiar with Persian)
Patients do not have mental retardation, blindness, deafness, physical problems and mobility disabilities.
Be interested in participating in the study.
Patients in the adult age group (18 to 65 years)
Cancer patients who have been diagnosed for at least one month
Have had at least two sessions of chemotherapy
Be treated with one of the AC regimens (adriamycin and cyclophosphamide), the CAF regimen (cyclophosphamide, adriamycin and 5-fluorouracil) or the CEF regimen (cyclophosphamide, epirubicin, 5-fluorouracil).
Positioning at a functional level of zero to one based on the performance level criteria of the Eastern Participatory Oncology Group affiliated to the ECOG (WHO)
Exclusion criteria:
According to the diagnosis of a psychiatrist in the case, she has an active mental illness and to take drugs related to the active "mental" illness.
Have any registered metastases.
Treatment with anticoagulants
History of any cancer other than breast cancer
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples in the test or control group is done using envelopes that have already been prepared using a random number table. In this way, the researcher first randomly determines that the patients to whom the odd number belongs to the experimental group and those to whom the even number belongs to the control group. He then closes his eyes and places his finger on one of the digits in the random number table. While the direction of movement is predetermined. By moving in the table of random numbers, the researcher selects the required number of samples of even and odd numbers.
All numbers will be placed in separate envelopes and all will be placed in a box. When the samples enter the study with the conditions and criteria of easy entry, then the number one card is opened for him and depending on whether this card has an even or odd number, they will be placed in one of the two groups of test or control. Thus, sampling will continue until the specified sample volume is reached. The researcher will consider the loss of samples according to the set exclusion criteria.
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
Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.592
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
Score from the sleep quality questionnaire
Timepoint
Immediately before the intervention and after the end of the eighth week
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
Score from the fatigue severity questionnaire
Timepoint
Immediately before the intervention and after the end of the eighth week
Method of measurement
Piper Fatigue Scale (PFS)
Intervention groups
1
Description
Intervention group: According to the exercise program compiled by a physical education specialist, in this study, sports intervention in the intervention group will be performed during eight weeks in the form of three sessions per week, each session lasting 35 to 40 minutes. In this study, exercise protocol in a structured way and at home will include three parts: warm-up, aerobic exercise and cooling.On the first day, the prepared package will include the required sports equipment, a CD containing training videos of sports movements, an illustrated training booklet and an internet package with a volume of five gigabytes. On the day of delivery of equipment, all sports movements are taught to patients by the researcher. After the training, in order to ensure the accuracy of learning, patients are asked to perform individual exercises in the presence of the researcher
Category
N/A
2
Description
Control group: They receive only routine care and complete the questionnaires immediately before the start of the study and eight weeks later.