Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000772044
Ethics application status
Approved
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
16/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phantom breast syndrome in women after surgery for breast cancer
Scientific title
Presence of phantom breast sensation and related symptoms in a group of women who have undergone mastectomies for the treatment of breast cancer
Secondary ID [1] 252684 0
Not have secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 258176 0
Phantom breast syndrome 258180 0
Condition category
Condition code
Cancer 258358 258358 0 0
Breast
Surgery 258359 258359 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The evaluation will conducted by questionnaire constructed with closed questions that the patients reported: type of surgery, time, number of sessions of radiotherapy and chemotherapy, feeling the presence of breast withdrawal, infection, pain (local breast removed or isolated in other body parts other than breast) pain intensity, factors that improvement or worsening pain, prosthesis or reconstruction, winged scapula, difficulty in daily activities (dressing and eating), psychological and physical treatment after treatment for breast cancer. The sociodemographic variables will be analyzed: age, marital status, education and occupation or retirement, weight and height. The questionnaire is administered face to face interview with duration the approximate 60 minutes, each participant completes the questionnaire once only occasions.
Intervention code [1] 257197 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259206 0
Presence of phantom breast sensation and related symptoms in a group of women with mastectomies. Evaluation will achieved by questionnaire constructed with closed questions that the patients reported.
Timepoint [1] 259206 0
Evaluation will achieved by questionnaire constructed with closed questions that the patients reported 6 months to 10 years after mastectomy.
Secondary outcome [1] 265594 0
Nill
Timepoint [1] 265594 0
Nill

Eligibility
Key inclusion criteria
Women who underwent surgery for the treatment of breast cancer.
Minimum age
21 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with breast cancer who did not undergo surgical treatment

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2908 0
Brazil
State/province [1] 2908 0

Funding & Sponsors
Funding source category [1] 257653 0
Self funded/Unfunded
Name [1] 257653 0
Country [1] 257653 0
Primary sponsor type
Individual
Name
Jose Maria Pereira de Godoy
Address
Avenida Constituicao 1306
Sao Jose do Rio Preto-Sao Paulo
Cep:15025-120
Country
Brazil
Secondary sponsor category [1] 256870 0
None
Name [1] 256870 0
Address [1] 256870 0
Country [1] 256870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259663 0
Research Ethics Committee of Medicine School of Sao Jose do Rio Preto-FAMERP-Brazil
Ethics committee address [1] 259663 0
Avenida Brigadeiro Faria Lima 5416
Sao Jose do Rio Preto-Sao Paulo
Cep:15090-000
Ethics committee country [1] 259663 0
Brazil
Date submitted for ethics approval [1] 259663 0
Approval date [1] 259663 0
13/07/2009
Ethics approval number [1] 259663 0
288-2009

Summary
Brief summary
The aim of this study will to assess the presence of phantom breast sensation and related symptoms in a group of women with mastectomies. The evaluation will conducted by questionnaire constructed with closed questions. For statistical analysis we used the percentage (%), mean and median for age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31641 0
Address 31641 0
Country 31641 0
Phone 31641 0
Fax 31641 0
Email 31641 0
Contact person for public queries
Name 14888 0
Maria de Fatima Guerreiro Godoy
Address 14888 0
AV Constituicao 1306
Sao Jose do Rio Preto-Sao Paulo
CEP:15025-120
Country 14888 0
Brazil
Phone 14888 0
55 17 32326362
Fax 14888 0
Email 14888 0
godoyjmp@riopreto.com.br
Contact person for scientific queries
Name 5816 0
Jose Maria Pereira de Godoy
Address 5816 0
AV Constituicao 1306
Sao Jose do Rio Preto-Sao Paulo
CEP:15025-120
Country 5816 0
Brazil
Phone 5816 0
55 17 32326362
Fax 5816 0
Email 5816 0
godoyjmp@riopreto.com.br

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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