The effect of a Communication Program on the Psychological Distress of Elderly Cancer Patients who reffered to the Selected Centers Affiliated to the Isfahan Univercity of Medical Sciences in 2015.
Determining the effect of a communicational program on psychological distress of the elderly cancer patients who referred to selected medical centers of Isfahan University of Medical Sciences during 2015
This study was a two-group before-after clinical trial that was conducted during 2015 at Al-Zahra hospital and Seyyed-Al-Shohada hospital which are affiliated to Isfahan University of Medical Sciences. 64 elderly patients were randomly allocated into two groups of intervention and control groups. The intervention included three weeks of communicational program, educational booklet, giving homework and monitoring the distress before and after the communicational sessions. Communicational intervention was conducted in 6 20-minute sessions according to patient’s needs and conditions. Sessions were conducted twice a week for three weeks individually and in person along with phone follow-ups and encouragement for doing the homework. The control group received the routine care and at the end of the intervention all of the issues were explained to them at one session. Demographic characteristics questionnaire and Kessler Psychological Distress Scale were used for measuring patient’s distress. The inclusion criteria were being 60 years old or older and having cancer, having knowledge about their cancer diagnosis, being able to speak and make verbal communication, not participating in any other sessions for other treatment methods during the past 6 months and not being addicted to narcotics and psychotropic substances. Exclusion criteria were death of the patient and unwillingness to participate in the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010725897N1
Registration date:2016-05-28, 1395/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Fateme Hejazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7140
Email address
fahejazi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Fateme Hejazi geriatric nursing graduate student & Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Communication Program on the Psychological Distress of Elderly Cancer Patients who reffered to the Selected Centers Affiliated to the Isfahan Univercity of Medical Sciences in 2015.
Public title
The effect of a Communication Program on the Psychological Distress of Elderly Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Seniors aged 60 years or older with cancer (Types of Cancer); The definitive diagnosis of cancer by medical oncologist & Life expectancy of at least six months (According to serfaty et al. 2012); Patients are aware of their cancer diagnosis; Patients have the ability to talk and communicate verbally; Willingness to participate in the study and randomly placed in groups; Previous participate in the meetings of up to six months before other treatments (Like therapy, spiritual therapy, relationship therapy, etc.) (According to serfaty et al. 2012); Lack of diseases other than cancer such as acute febrile or chronic physical disorders specialist physician and medical records. (Like the flu, debilitating diseases, cardiovascular, endocrine, respiratory, liver, skeletal muscle, kidney); Lack of mental disease or mental illness who have specialist physician and the patient is inserted; The absence of distress-causing accident, according to the patient in the last six months (Such as the recent death of a loved one such as a spouse or close friend, the loss of everything that is valuable for the individual, divorce, incurable diseases, loss of limb, loss of jobs, relocated to a new city, bankruptcy financial debt severe, imprisonment, disputes and persistent inconsistency with wife); Lack of addiction to narcotics and psychotropic substances, according to the patient and medical records
Exclusion criteria: Not wanting to continue cooperation in research; The use of other types of communication programs while studying; Inability to attend meetings regularly so that communication meetings have missed two or more consecutive meetings; Elderly death during the study
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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
University of Medical Sciences, Isfahan
Street address
School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
ir.mui.rec.1394.3.585
Health conditions studied
1
Description of health condition studied
Psychological Distress
ICD-10 code
F99-F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Psychological Distress
Timepoint
Before intervention, after intervention
Method of measurement
Kessler Psychological Distress Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group communications during the six sessions of approximately twenty minutes due to the conditions and needs of patients was performed. During the three-week sessions, twice a week were conducted individually and in person. Telephone follow-up to attend the next meeting to coordinate and encourage the patient to do homework. Time sessions with the agreement of the patients was determined. All meetings were held in the hospital and at the time of admission. Training manual in the test group was placed in the first session, they were asked to provide manual control group did not. Join this session to order and mutual understanding, explain the objectives of the intervention, simple and concise explanation about cancer and its treatment process and effects of this disease on patients' quality of life. Patients the opportunity to talk about various topics, including the expression of uncertainties, questions and concerns and reveal the deepest feelings and emotions related to their experiences of illness and distress-inducing events were live. In the speech, physical, psychological, social and spiritual patient was evaluated as a basis for subsequent meetings. The next meeting, which is to help the client to cope and adapt to problems using strategies based assignments and training manual approved by the faculty of professors, to be discussed, explained.In the second session to encourage clients to speak on the issue of the impact of the disease on physical aspects (impact of the disease on physical conditions, beliefs and expectations of patients about their condition, plans and hopes for the progress of the disease), were encouraged. And obligations commensurate with their potential problems, it is presented. And the subjects were asked to do that task to the next meeting. In the second session, clients talking about psychological distress caused by the disease subject (patient relationship between different emotions, physical symptoms and disabilities caused by the disease and patients' concerns about the ability to adapt, loss of control, and readiness to accept help and discuss issues surrounding death), were encouraged. And adaptation strategies in accordance with the manual and training tailored to the patient's condition was presented to them. And the sample was asked to do the task to the next meeting. In the fourth session, clients to talk about the social effects of the disease (the disease affect behavior and mood, and ability to perform the role of the full impact of the disease on individuals favorite client) were encouraged. And how to manage it in accordance with the instruction manual and tailored to the patient, was presented to them. And the sample was asked to do the task to the next meeting. In the fifth session, clients are talking about spiritual matters illness and disease issues (issues surrounding the concept of disease, suicide and death, the ability to modify and spiritual changes, compromise and consistent with the spiritual, forgiveness of others and accept unfinished works), were encouraged. And the appropriate task presented to them. And the sample was asked to do the task to the next meeting. Sixth session, summing up previous sessions and announced the termination of negotiations. Also, researchers through questionnaires completed the questionnaire psychological distress, paid in the last session. In each session, then discuss things, applicable solutions discussed, and the optimum solution according to requirements and potential problems the patient is recommended. They also provide the basis for the assignment to be patient. And client feedback in each session examined the implementation of assignments in previous sessions. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can contact the researcher.
Category
Other
2
Description
The control group received routine care. Furthermore, after three weeks by nearly two-hour meeting, the contents of the manual are briefly described for each of the control group. And measures of psychological distress were completed the questionnaire again. In the end, brochure, available to patients and their families were in the control group. Telephone researcher also laid the experimental and control groups, so if you create questions about the contents of the manual, they can contact the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Fateme Hejazi
Street address
Al-Zahra hospital, Hakim Nezami street, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Sydalshhda Hospital
Full name of responsible person
Fateme hejazi
Street address
Sydalshhda Hospital, Shiry bridge., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahdi Nemat Bakhsh
Street address
Faculty of Medicine, University of Medical Sciences, St. thousand acres, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Masoud Bahrami
Position
PhD / Associate Professor, Faculty of Nursing, University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7542
Fax
Email
bahrami@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Hejazi
Position
Geriatric Nursing Student Nursing Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, University of Medical Sciences, St. thousand acres, Isfahan, Iran