The Effect of family-focused supportive program on chemotherapy complications of leukemia patients
Design
The study will have intervention group (30 patient- at Shariati Hospital) and control group (30 patients-at Taleghani hospital). In each hospital the sampling will be Convenience. Allocation to the groups will be done non randomly.
Settings and conduct
Chemotherapy wards of Shariati andTaleqani hospitals will form the field.Patients and their families in the intervention group will be monitored for up to three months while being under consolidation chemotherapy. In each session of chemotherapy the type, severity and discomfort of chemotherapy will be determined. In this study, only the statistician blinding will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients: age over 18 years old; referring to chemotherapy clinic and receive the first or second consolidation chemotherapy.
Inclusion criteria for patients’ relatives: age between 18 to 60 years old; being the first people of patient; giving care to patient at home; and obedience by patient.
Non-inclusion criteria for patients: having a history of chemotherapy in family member.
Non-inclusion criteria for patients’ relatives: being one of the health care workers.
Intervention groups
In intervention group educational sessions will be held for participants regarding to chemotherapy complication control.
Also the nutritional regimen will be determined for patients and consultation and guidance by phone will continue for patients and their families for three months during chemotherapy. If the participants need psychiatric counseling, an appointment with one of the psychiatrists of the hospital for intervention group will be coordinated.
In control group Patients will receive the only routine intervention including staffs’ oral explanation in the field of chemotherapy. This routine intervention will also be conducted in the hospital for intervention group.
Main outcome variables
24 chemotherapy complications including nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170803035479N3
Registration date:2019-03-01, 1397/12/10
Registration timing:registered_while_recruiting
Last update:2019-03-01, 1397/12/10
Update count:0
Registration date
2019-03-01, 1397/12/10
Registrant information
Name
Leila Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4322
Email address
l-sayadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of family-centered supportive program and routine care on chemotherapy complications among leukaemia patients
Public title
Family-centered supportive program and chemotherapy complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for patients: Have age over 18 years old
Being able to understand and speak Persian and have the ability to read and write
Have awareness of time, place and person
Consent to participate in the study
Acute lymphatic leukemia have been diagnosed for them
For chemotherapy, at least, one of the family members who take care of patient at home accompanies him/her
Have been referred to chemotherapy clinic and have being under consolidation chemotherapy
Be the first or second turn of consolidation chemotherapy for these people
Family members Inclusion Criteria: Have age between 18 to 60 years old
Ability to understand Persian language and speak Persian, have ability of reading and writing
Being aware of time, place and person
being one of the first degree relatives of patient, and providing patient care at home and willing to participate in the study
The patient obeys the relative
They are personnel of the health system
Exclusion criteria:
Patients exclusion criteria: Have history of Chemotherapy in family members
being one of the health system personnel
Family member exclusion criteria: being one of the health system personnel
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding of patients, their family and researcher in this study is not possible and only statistician will not be aware of the allocation of patients to control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional research ethics committee of Nursing, Midwifery & Rehabilitation school
Street address
School of Nursing and Midwifery,Tehran University of Medical Sciences, Nosrat street. Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.TUMS.FNM.REC.1397.165
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
Nausea or vomiting before treatment
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
2
Description
Nausea after treatment
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
3
Description
Vomiting after treatment
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
the Chemotherapy Symptom Assessment Scale
4
Description
Constipation
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
the Chemotherapy Symptom Assessment Scale
5
Description
Diarrhea
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
6
Description
pain
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
7
Description
Shortness of breath
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
8
Description
Signs of infection
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
9
Description
Bleeding or bruising
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
10
Description
Needles/numbness of hands and feet
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
11
Description
Problems with the skin and nails
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
12
Description
Hair loss
Timepoint
Before starting the first or second chemotherapy, and then in each chemotherapy session until 3 months - number of chemotherapy depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
13
Description
A sore/sensitive mouth or throat
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
14
Description
A change in appetite
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
15
Description
Weight gain or loss
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
16
Description
Sore/scratchy/dry eyes
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
17
Description
Feeling weakness
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
18
Description
Feeling unusual fatigue
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
19
Description
Difficulty sleeping
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
20
Description
Headaches
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
21
Description
Feeling distressed/anxious
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
22
Description
Feeling pessimistic/unhappy
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
23
Description
Change in sexual life
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
24
Description
Irregular periods (in female patients)
Timepoint
Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol
Method of measurement
The Chemotherapy Symptom Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention, performed in this study, is a family-based support program (Including family and patient education, determining the type of patient's diet, and psychological support). In order to patient and family member education, pamphlets/ information booklets and educational videos will be prepared. At the first meeting with patients and their family members before starting consolidated Chemotherapy (first stage or second stage), which will be held at the chemotherapy clinics, the training video provided for them will be displayed as well as video and pamphlet given to them. In the session oral explanations on the content of video and educational pamphlets will also be provided for families and patients, and the questions posed by them will be answered. This training session will be held for at least an hour. The number of patients and family members attending this session is based on the number of patients with acute lymphatic leukemia under chemotherapy on that day. After that according to the patient's condition a dietitian will be consulted in order to prepare a patient's diet. Prepared diet will be given to the family member after approval of doctor at the next session of chemotherapy. And guidelines on appropriate nutrition of these patients will be provided for the family. Afterwards, patients and their families will be followed up by phone. During the follow up period, the necessary supportive programs are used in accordance with the new drug or procedure and also controlling the side effects of chemotherapy in families and patients will be presented. Phone follow-up period will be continued for three months during chemotherapy for each patient and their families. Since, Consolidation chemotherapy is performed in these patients phone follow up will be done every two weeks (between two weeks and up to three months). If in the training sessions and in phone follow-up, need to psychological counseling on problems of patients after chemotherapy for patient and the family is confirmed, they will be referred to a psychiatrist at the Hematology Research Center
Category
Other
2
Description
Control group: Patients in control group, will be received the only routine intervention of chemotherapy clinics that include oral explanations of staff in the field of chemotherapy. This routine intervention is also being conducted at the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mehrpoor
Street address
Shariati hospital, Jalal Ahmad Street, Kargar street