Determine the impact of an exercise program on coping self-efficacy and quality of life of breast cancer patients
Design
A clinical trial with a control group, one-sided blind, randomized, is performed on 60 patients. A coin toss is used for randomization.
Settings and conduct
Randomized, one-sided, blinded clinical trial with before and after intervention design in breast cancer survivors referring to Behshahr Oncology Center-Iran, who has a medical record. The number of samples is selected by available sampling method and based on simple randomization, they are placed in two exercise and control groups. In relation to the research, information is provided for the participants. The informed consent form is completed. The intervention group will receive a 12-week supervised exercise program. The control group only performed their normal physical activities.
Participants/Inclusion and exclusion criteria
Eligibility criteria: Patients 15 -75 yr. with grade I-III; Completed intensive breast cancer treatment; Recommendation from the oncologist; Three weeks after chemotherapy or R/T; Exclusion criteria: Having an acute illness or a serious psychiatric illness; Patients with recurrence or metastasis; Suffering from other diseases; Ataxia
Intervention groups
The intervention group will receive a exercises program including 12-week supervised exercises developed by a exercise physiologist, 3 days a week for 50-60 minutes. This program will include aerobic exercises, resistance exercises, flexibility exercises and balance exercises.
The control group only performed their normal physical activities and were provided with educational brochures about routine care.
Main outcome variables
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230919059471N1
Registration date:2023-10-28, 1402/08/06
Registration timing:prospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Faridokht Yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4229 8064
Email address
faridokht.yazdani@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of an exercise program on coping self-efficacy and quality of life in breast cancer patients.
Public title
The impact of exercise on breast cancer quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 15 to 75 who have been diagnosed with grade I to III breast cancer based on pathology;
Have completed intensive breast cancer treatment (including surgery, chemotherapy, or radiation therapy);
Have the recommendation and permission to participate in the exercises program from the oncologist;
Three weeks after chemotherapy or radiation therapy;
Less than 6 months have passed since chemotherapy or radiation therapy;
Patients should be able to do aerobic and resistance exercises.
Exclusion criteria:
Having an acute illness or a serious psychiatric illness;
Patients with recurrence or metastasis;
Suffering from other diseases or other continuous treatments such as asthma or osteoporosis and heart disease and blood pressure; Anemia with a decrease in red blood cells;
Ataxia (imbalance in walking);
Patients have not been approved by the oncologist for exercise.
Age
From 15 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are selected using available sampling method and are placed in two exercise and control groups based on simple randomization. Participants are randomized by random assignment through a coin toss into two exercise and usual care groups. The face of the coin (i.e. lion = control group), and the back of the coin (i.e. line = intervention group) are considered.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the medical personnel (doctors, nurses, physiotherapists, etc.) who are responsible for the care of the patients, and those who analyze the data and evaluate the outcome, and those who prepare the draft of the article; They are blinded to study group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, an exercise program includes a 12-week supervised exercise program set by an exercise physiologist. This program will include aerobic exercises, resistance exercises, balance exercises and flexibility exercises in a combined manner and in a regular sequence, taking into account the guidelines of the American College of Sports Medicine (ACSM). The implementation of the exercise program is carried out by an exercise coach who knows the details of exercise in breast cancer. Timing, duration of exercise, intensity of exercise and type of combined exercises are determined separately.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University-Najafabad branch
Street address
Islamic Azad University, Najaf Abad branch, University Boulevard
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2023-10-05, 1402/07/13
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1402.199
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
The coping self-efficacy score in the questionnaire has 3 dimensions (stopping emotions and unpleasant thoughts), (problem-oriented strategy), and (receiving support from family and friends). The total scores for each item of that dimension are calculated together. Respondents must answer at least 80% of the scale items.
Timepoint
Measuring coping self-efficacy at the beginning of the study (before the start of the intervention) and at the end of the intervention (12 weeks after the start of the study).
Method of measurement
Chesney et al. Coping Self-Efficacy Questionnaire (CSES)
2
Description
The quality of life score of breast cancer patients in the QLQ-Br23 questionnaire includes 23 items that are divided into two dimensions. The first dimension includes four functional scales, (sexual function, sexual pleasure, and future perspective); While the second dimension includes four symptom scales (systemic treatment side effects, breast symptoms, arm symptoms, hair loss discomfort). Each item is scored from 1 to 4 points. Scores are converted to a 0-100 score after linear transformation. The highest scores correspond to better performance (except for sexual performance and sexual pleasure). On the other hand, higher scores on the symptom scale dimension are associated with higher persistence of signs and symptoms.
Timepoint
Measuring quality of life at the beginning of the study (before the start of the intervention) and at the end of the intervention (12 weeks after the start of the study).
Method of measurement
Breast Cancer Quality of Life Questionnaire (EORTC-QLQ-BR23)
Secondary outcomes
1
Description
Reduce anxiety
Timepoint
End of the intervention (after 12 weeks from the start of the intervention)
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Intervention groups
1
Description
Intervention group: intervention group: exercise group; They receive an exercise program including 12-week supervised exercises developed by a sports physiologist, 3 days a week for 50-60 minutes. This program will include aerobic exercises, resistance exercises, flexibility exercises and balance exercises. Aerobic exercise class consists of three parts: warm-up, aerobic exercises, and cool-down.
Category
Rehabilitation
2
Description
Control group: Patients in the control group only do their normal physical activities and are provided with educational brochures about routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Sciences (Khatam Al Anbia hospital, Behshahr)
Full name of responsible person
Afshin Amirkhanlou
Street address
Abbas Abad Road, Imam Reza Boulevard, Motahar
City
Behshahr
Province
Mazandaran
Postal code
0000000000
Phone
+98 11 3457 9001
Email
shirinkhheadnurse@gmail.com
Web page address
https://h-khatam.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rafiei
Street address
Islamic Azad University, Najaf Abad branch, University Blvd.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2305
Email
info @ iaun.ac.ir
Web page address
https://iaun.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Faridokht Yazdani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Najaf Abad Branch, University Blvd