(1)Objectives: To determine the effect of telephone support on different dimensions of supportive care needs of women with breast cancer (2) Design: This study is randomized trials with control and intervention group. A total of 62 women with breast cancer who are referred for treatment (chemotherapy, radiotherapy, surgery) to tertiary hospitals in Kashan and randomly placed in one of the intervention or control groups. (3)Setting and conduct: Telephone intervention will be performed for a month in intervention group. Data will be collected at three phases (baseline, two weeks and one month after intervention) in both groups. (4) Participants including major eligibility criteria: Eligibility to participate was restricted to people diagnosed with cancer who are treated for first round and the exclusion criteria are unwillingness to participate in the study and death. (5) Interventions: The researcher will call patients in the intervention group twice a week, and they can also get in touch with the researcher if they have any problem or question. The length of each call will be between 20-15 minutes. Researcher will talk about their issues and problems and patients’ questions will be answered as well. The control group will only receive usual care. (6)Main outcome: The primary outcome is supportive care needs and the secondary outcomes are different dimensions of supportive care need that will be compared between two groups of participant using the supportive care needs survey (SCNS- SF 34).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102430465N1
Registration date:2016-12-18, 1395/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Nazi Nejat
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3524
Email address
n.nejat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of telephone support on supportive care needs of women with breast cancer
Public title
Effect of telephone intervention on supportive care needs of patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Eligibility to participate was restricted to people diagnosed with cancer; aged between 18-80 years; aware of their diagnosis; are treathed for first round; physically and mentally capable of participating in the study ( the ability to read and write and lack of hearing loss and speech problems), telephone access at home, and living in Kashan.
Exclusion criteria: The the exclusion criteria are unwillingness to participate in the study and death
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
using randomized block design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Baseline, 2 weeks after the intervention, one month after intervention
Method of measurement
Supportive care needs survey short form 34(SCNS-SF34)
Secondary outcomes
1
Description
Psychological needs
Timepoint
baseline, two weeks and one month after intervention
Method of measurement
Psychological dimension of SCNS-SF34
2
Description
Health system & information needs
Timepoint
baseline, two weeks and one month after intervention
Method of measurement
Health system & information dimension of SCNS-SF34
3
Description
Physical & daily living
Timepoint
Baseline, two weeks and one month after intervention
Method of measurement
Physical & daily living dimension of SCNS-SF34
4
Description
Patient care & support
Timepoint
Baseline, two weeks and one month after intervention
Method of measurement
Patient care & support dimension of SCNS-SF34
5
Description
Sexual needs
Timepoint
Baseline, two weeks and one month after intervention
Method of measurement
Sexual dimension of SCNS-SF34
Intervention groups
1
Description
Intervention group: Telephone intervention will be performed for a month. The first contact with participants will be done during a week after the first meeting. The researcher will call patients in the intervention group twice a week, and they can also get in touch with the researcher if they have any problems or questions. The length of each call will be between 20-15 minutes. The researcher will talk about their issues and problems, and patients’ questions will be answered as well. The content of telephone conversations will be written based on the results of new researches and using scientific resources in the field of breast cancer and will be approved by the Department of Oncology in Kashan University of Medical Sciences. In addition, patients’ questions in specialized areas will be answered after consultation with an oncologist. The contacts time will be set based on patients’ willingness. A phone number will be provided by the researcher for the intervention group so they can get in touch with the researcher if they have any problems or questions during the weeks in determined hours every day (9 am to 12 noon and 4 pm to 9 pm).
Category
Other
2
Description
Control group: The control group will only receive usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mehran Sharifie
Street address
ghotb Ravandie Boulevard , Parastar Boulevard
City
Kashan
2
Recruitment center
Name of recruitment center
Matinie hospital
Full name of responsible person
Dr Mehran Sharifie
Street address
Amir Kabir Street
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research ofArak University of Medical Sciences