Protocol summary
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Study aim
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Investigation effect of stress management program on psychological distress of cancer patients and caring burden and quality of life of their caregivers
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Design
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Parallel randomized superiority controlled trial, using a random blocking allocation that cannot be blinded and sample size will 60.
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Settings and conduct
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The research will be performed in Bahar Hospital in Shahroud that conducted. Standard questionnaires of quality of life, caring burden and stress, anxiety and depression at the beginning and 7 days after intervention will be completed.
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Participants/Inclusion and exclusion criteria
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Caregiver and patient age at least 15 years old; no psychological disorders in the caregiver; no drug addiction in the caregiver; no hearing or vision impairment in the caregiver. The caregiver should have the most contact with the patient; ability to access the Internet and online mass communication; have the minimum ability to use smartphones and social networks; no participation in other supportive interventions; the caregiver should not be a member of the healthcare system ; the caregiver is a family member of the patient; definitive diagnosis of cancer has been made by a doctor; the stage of the cancer is known; patients undergo chemotherapy.
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Intervention groups
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Intervention group: For the intervention group, 4 weekly sessions of 60 minutes are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Outline of the session: (1- Stress signs/symptoms and their effect on health 2- Relaxation exercises 3- Social skills training, communication techniques, communication styles (aggressive, passive and assertive) 4 - Coping strategies (emotion and problem based).
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Main outcome variables
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Quality of life; caring burden
General information
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Reason for update
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Due to the lack of permission from the medical center to implement the intervention on the anticipated date, sampling and implementation of the intervention in the current study were conducted from January 16, 2024, to two months thereafter.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180728040617N3
Registration date:
2021-03-14, 1399/12/24
Registration timing:
prospective
Last update:
2025-01-20, 1403/11/01
Update count:
1
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Registration date
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2021-03-14, 1399/12/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-16, 1402/10/26
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Expected recruitment end date
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2024-03-19, 1402/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers
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Public title
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Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Caregiver and patient age at least 15 years.
No psychological disorders in the caregiver.
No drug addiction in the caregiver.
No hearing or vision impairment in the caregiver.
The caregiver should have the most contact with the patient.
Ability to access the Internet and online mass communication software.
Have the minimum ability to use smartphones and social networks.
Non-participation in other supportive interventions.
The caregiver should not be a member of the health care system.
The caregiver is a family member of the patient.
The definitive diagnosis of cancer has been made by a doctor.
The stage of the disease of each patient is known
Patients undergo chemotherapy.
Exclusion criteria:
Do not participate in the post-test.
Absence from more than two sessions in support sessions.
The reluctance of the caregiver to participate in the sessions.
Patient death during the study
Transfer the patient to other medical centers
Occurrence of stressful events (except for the usual treatment process) for the patient or caregiver
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Age
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From 15 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Patient's psychological distress of each caregiver
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Caregivers will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 60 in the present study, 15 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-07, 1399/11/19
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Ethics committee reference number
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IR.SHMU.REC.1399.158
Health conditions studied
1
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Description of health condition studied
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Cancer
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ICD-10 code
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C00-C97
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ICD-10 code description
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Malignant neoplasms
Primary outcomes
1
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Description
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Caregivers Caring burden
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Timepoint
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At the beginning of the study (before the intervention) and 7 days after intervention.
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Method of measurement
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Novak & Guest Caring Burden Questionnaire
2
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Description
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Caregivers Quality of Life
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Timepoint
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At the beginning of the study (before the intervention) and 7 days after intervention.
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Method of measurement
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Quality of Life Questionnaire SF-36
Secondary outcomes
1
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Description
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Patients' psychological distress
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Timepoint
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At the beginning of the study (before the intervention) and 7 days after intervention.
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Method of measurement
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Lovibond Depression, Anxiety and Stress Scale (DASS-21)
Intervention groups
1
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Description
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Intervention group: For the intervention group, 4 weekly sessions of 60 minutes are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Outline of the session: (1- Stress and its effect on health, stress signs/symptoms 2- Relaxation exercises and their benefits 3- Social skills training, verbal/non-verbal communication techniques, different communication styles (aggressive, passive and assertive) 4 - Teaching coping strategies with stress (emotion-oriented and problem-oriented). Data collection tools included demographic information form, SF-36 quality of life questionnaire, Novak & Guest caring burden and Lovibond stress, anxiety and depression scale (DASS-21) which were administered by all caregivers and their patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention.
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Category
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Other
2
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Description
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Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Some of the patient and caregivers' demographic information can be shared after unidentifying individuals. All of the caregivers quality of life, caring burden and patients psychological distress assessment information can be shared with caregivers after unidentified individuals.
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When the data will become available and for how long
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After publishing the article
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To whom data/document is available
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Project partners
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Under which criteria data/document could be used
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People who do similar research
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From where data/document is obtainable
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It will be done by email with the person in charge of the project.
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What processes are involved for a request to access data/document
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Data is made available to individuals via email.
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Comments
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