The effects of guided imagery on the quality of life of Women with Breast Cancer
Design
Clinical trial with two groups of control and intervention on 58 patients. Excel software rand function was used for randomization.
Settings and conduct
Women with breast cancer referred to Ramezanzadeh Radiation Therapy Center in Yazd who have undergone radiotherapy and chemotherapy during the last 4 months. Demographic and QLQ_C30 questionnaires will be sent electronically for patients. In the intervention group, in addition to receiving routine care, they will be referred to a one-and-a-half-hour imaging session that will be performed by a single researcher in his office. After 3 weeks and after a one-month follow-up period, the questionnaires will be sent to both groups electronically again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
one to three breast cancer stages in the initial diagnosis؛ At the beginning of radiation therapy or chemotherapy sessions, or at most 4 months have passed since the end of the sessions؛ Ability to read and write and be able to hear؛ Ability to participate in counseling sessions؛ Willingness to cooperate in the study؛ Types of surgery including lumpectomy, mastectomy (radical, total, etc.)؛ Ability to use a smartphone to receive questionnaires and listen to audio recorded for home practice.
Exclusion criteria:
Having other cancers; illnesses or disabilities that prevent participation in counseling sessions and exercises؛ Having a mental illness under treatment؛ Having great stresses such as the death of loved ones and divorce in the last 6 months؛ Substance abuse؛ Simultaneous participation in another study; Pregnancy.
Intervention groups
Intervention group: The consultation based on guided imaging.
Control group: routine care
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201222049797N2
Registration date:2021-12-07, 1400/09/16
Registration timing:prospective
Last update:2021-12-07, 1400/09/16
Update count:0
Registration date
2021-12-07, 1400/09/16
Registrant information
Name
fatemeh zahra memar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5227 4486
Email address
memar_fateme@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-15, 1400/09/24
Expected recruitment end date
2021-12-20, 1400/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of guided imagery on the quality of life of Women with Breast Cancer
Public title
The effects of guided imagery on the quality of life of Women with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At the initial diagnosis of stage one to three breast cancers
At the beginning of radiation therapy or chemotherapy sessions, or at most 4 months have passed since the end of the sessions
Ability to read and write and be able to hear
Ability to attend counseling sessions
Willingness to collaborate in the study
Types of surgery including lumpectomy, mastectomy (radical, total, etc.)
Ability to use a smartphone to receive questionnaires and listen to recorded audio for homework
Exclusion criteria:
With other cancers
An illness or disability that prevents you from attending counseling and exercise sessions
Having a mental illness being treated
Having great stress like the death of a loved one and divorce in the last 6 months
Drug abuse
Simultaneous participation in another study
Pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The specified sample size is 58 women. Each woman will be assigned a number between 1 and 58, which is created by the online site http://www.randomization.com. Due to the fact that this study has two groups, the first generation randomization model is used that has two groups; A and B. The samples are entered in each group by order and are got numbers.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Morad Maleki Street
City
Isfahan
Province
Isfehan
Postal code
8471846596
Approval date
2020-12-26, 1399/10/06
Ethics committee reference number
IR.SSU.RSI.REC.1399.033
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
quality of life of Women with Breast Cancer
Timepoint
Questionnaire QLQ_C30 and demographics in the baseline and after 3 weeks and after a one-month follow-up period, the questionnaires will be given electronically to people in both groups.
Method of measurement
Through quality of life questionnaires of the European Cancer Research and Treatment Organization
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving routine care, samples are guided to a one-and-a-half-hour imaging session performed by a single researcher in her office. Mental imaging steps and contents expressed are recorded by the patient's mobile phone and the participant is asked to listen to this recorded sound every day from 9 to 10 pm for three weeks and do mental imaging and related tasks specified by the researcher.
Category
Behavior
2
Description
Control group: The control group will receive routine care and will be on a waiting list for receiving intervention, 6 weeks after a one-month follow-up session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ramezanzadeh Radiotherapy Center, Yazd
Full name of responsible person
Mohammad Hasan Gholami
Street address
Shahid Motahari St. - Shahid Ramazanzadeh Radiotherapy Center
City
Zarinshahr
Province
Yazd
Postal code
۸۹۱۷۶۵۷۹۶۱
Phone
+98 35 3725 1174
Fax
+98 35 3724 4078
Email
partodarmani@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirjalili
Street address
Yazd, Bahonar Square, the central building of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Master of Midwifery Education
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Yazd, Safaieh, Bouali St., School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3824 1752
Email
maryammohammadi0224@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
کارشناس ارشد آموزش مامایی
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Yazd, Safaieh, Bouali St., School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3824 1752
Email
maryammohammadi0224@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Master of Midwifery Education
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Yazd, Safaieh, Bouali St., School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3824 1752
Email
maryammohammadi0224@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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