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The effect of mindfulness-based intervention on caregiver burden, perceived stress, and quality of life in family caregivers of patients with cancer

Protocol summary

Study aim
Determining the effect of mindfulness-based intervention on caregiver burden, perceived stress and quality of life of family caregivers of cancer patients.
Design
Clinical trial,including two intervention and control groups,sample size of 30 people per group (60 people in total),Convenience Sampling,random allocation
Settings and conduct
Location: Iran Mehr hospital in Birjand,The intervention group (n = 30) was divided into two groups of 15 individuals,Delivering exercise checklists and pamphlet summaries to participants at the end of each session,Participants were followed up by telephone during the two-month follow-up
Participants/Inclusion and exclusion criteria
Inclusion Criteria for Cancer Patients: Being at least 18 years of age or older, having a cancer diagnosis approved by a specialist physician undergoing cancer treatment, if the cancer treatment course is completed, more than four weeks after Do not end the treatment period Inclusion criteria for caregivers:Women and men aged 18-75 years, Ability to read, Having the main role of caring and family relationship with the patient, No cancer diagnosed in the past 4 years, Lack of regular treatment by a psychologist or psychiatrist, Failure to report the diagnosis of mental disorders and cognitive impairment by one's self, No history of suicide, No treatment with anti-psychotic and anti-convulsant drugs, No substance abuse or dependence in the past year, Lack of previous or current participation in mindfulness and other psycho-social programs. Exclusion Criteria: Having more than two sessions absent on schedule, Death of cancer patient during research.
Intervention groups
Intervention group: 8 sessions of 2 hours based on mindfulness and two-month follow-up Control group: no intervention
Main outcome variables
Perceived stress,caregiver burden and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190611043866N1
Registration date: 2020-03-31, 1399/01/12
Registration timing: retrospective

Last update: 2020-03-31, 1399/01/12
Update count: 0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Zeinab Mehrizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 4082
Email address
zeinab.mehrizi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-03, 1397/12/12
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based intervention on caregiver burden, perceived stress, and quality of life in family caregivers of patients with cancer
Public title
The effect of mindfulness-based intervention on caregiver burden, perceived stress, and quality of life in family caregivers of patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria for Cancer Patients: Being at least 18 years of age or older having a cancer diagnosis approved by a specialist physician undergoing cancer treatment if the cancer treatment course is completed, more than four weeks after Do not end the treatment period having a family caregiver who will take care of him at home Inclusion criteria for caregivers: Women and men aged 18-75 years able to read, write and speak Persian play a key role in patient care have a family relationship with the patient (spouse, child, parent or mother, sister or Brother, grandson, other relatives) Willingness to participate in the program lack of specific illness or unstable situation unable to care for a cancer patient No cancer diagnosed in the past 4 years No regular treatment by a psychologist or psychiatrist Lack of self-reported diagnosis of mental disorders and cognitive impairment Non-admission to psychiatric ward with diagnosis of psychiatric disorders in the past two years No history of suicide No treatment with anti psychotic and anti-convulsive drugs No substance abuse or dependence in the past year No recent recovery from substance abuse Lack of previous or current participation in mindfulness programs and other psycho-social programs Lack of do yoga and meditation exercises in the past year
Exclusion criteria:
Having more than two sessions absent on schedule Unwillingness or inability to continue participating in the study Death of cancer patient during research The occurrence of any physical or mental disorders that prevent the caregiving by the caregiver
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Referring to Iran-Mehr Hospital 60 family caregivers of patients with cancer are included in the study through available sampling. Then Samples were randomly divided into intervention and control groups, Respectively and one by one (each group 30).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study included two intervention and control groups (30 in each group). The intervention group received eight sessions of mindfulness program training for two hours and then completed the intervention Followed for two months. But during this time the control group does not receive any intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
No. 118, Taleghani Alley 17, Taleghani Ave, Esfarain, North Khorasan Province
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
ir.bums.REC.1397.306

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
weitzner's Quality of Life Questionnaire score
Timepoint
Before and after the intervention and two months after the intervention
Method of measurement
weitzner's Quality of life questionnaire for caregivers of cancer patients

2

Description
Cohen's perceived stress Questionnaire score
Timepoint
Before and after the intervention and two months after the intervention
Method of measurement
Cohen's perceived stress Questionnaire

3

Description
Zarit's caregiver burden Questionnaire score
Timepoint
Before and after the intervention and two months after the intervention
Method of measurement
Zarit's caregiver burden Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
session 1, goals and techniques included building a rapport with the client, obtaining information from the client, providing psycho-education on mindfulness, CBT, depression, and anxiety, identifying automatic thoughts and leading the client through a guided mindfulness meditation. session 2, goals and techniques included helping the client recognize that most of her thoughts are not facts, teaching the client to use the thought record, educating client about cognitive distortion. session 3, goals and techniques included educating diaphragmatic breathing and sleep hygiene; next, teaching the client a brief body scan exercise to reduce muscle tension. session 4, goals and techniques included introducing mindful daily activity, teaching mindful eating and mindful labelling on thoughts, feelings and behaviours. session 5, goals and techniques included introducing to enhancing recognition of personal consequences of chronic worry, having the client perform a cost-benefit analysis of her chronic worry, scheduling worry time and mindful worry-free zones. session 6, goals and techniques included generating a hierarchy of worries, imaginary exposure with acceptance, incorporating in vivo exposure through increased participation in planned events. session 7, goals and techniques included helping the client learn to identify and respond to early signs of relapse, collaborating with the client to generate responses to her early warning signs, helping the client practice developing a worry action plan. session 8, goals and techniques included reviewing the insights and techniques found most useful by the client, identifying obstacles to practice mindfulness, providing a checklist of the techniques included in the program.
Category
Behavior

2

Description
Control group: They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Mehr Radiotherapy and Oncology Hospital
Full name of responsible person
Ahmad Reza Sebzari
Street address
Opposite to Ghafari Street 30, Ghafari Street, Birjand, South Khorasan Province, Iran Mehr Hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6800
Email
iranmehr@bums.ac.ir
Web page address
https://iranmehr.bums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba kazemi
Street address
Central Organization of Birjand University of Medical Sciences, Ghaffari Street, Birjand, South Khorasan province
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3243 0076
Fax
+98 56 3243 0076
Email
public_r@bums.ac.ir
Web page address
https://www.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
20
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
Birjand University of Medical Sciences
Full name of responsible person
Zeinab Mehrizi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 118, Taleghani Alley 17, Taleghani St, Esfarayen, North Khorasan Province.
City
Esfarayen
Province
North Khorasan
Postal code
9661884915
Phone
+98 58 3723 4082
Fax
Email
zeinab.mehrizi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zeinab Mehrizi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 118, Taleghani Alley 17, Taleghani St, Esfarayen, North Khorasan Province.
City
Esfarayen
Province
North Khorasan
Postal code
9661884915
Phone
+98 58 3723 4082
Fax
Email
zeinab.mehrizi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zeinab Mehrizi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 118, Taleghani Alley 17, Taleghani St, Esfarayen, North Khorasan Province.
City
Esfarāyen
Province
North Khorasan
Postal code
9661884915
Phone
0098 58 372334082
Email
zeinab.mehrizi@gmail.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
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