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NCT01295463 Clinical Trial

Study of Information Received About Fertility and Infertility in Patients Who Have Finished Treatment for Cancer

Cancer Clinical Trial

Official title:
Descriptive Study to Evaluate the Information and Psychosocial Issues on the Risk on Infertility in Cancer Patients After Receiving Treatment in a Comprehensive Cancer Center

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01295463
Other study ID # ICO-FERTI
Secondary ID CDR0000695000EU-
Status Recruiting
Phase N/A
First received February 11, 2011
Last updated August 9, 2013
Start date December 2010

Study information
Verified date February 2011
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial Summary

RATIONALE: Learning about the amount of information on fertility and infertility by patients before they received treatment for cancer in a comprehensive cancer center may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying the amount of information on fertility and infertility received by patients before treatment of cancer in patients who have finished treatment.

Description:

OBJECTIVES:

Primary

- To determine the amount of information received on aspects of fertility and infertility in patients with cancer prior to receiving treatment in a comprehensive cancer center.

Secondary

- To analyze whether the information received by patients is related to the desire to be parents.

- To analyze whether the information received by patients is related to the desire to be informed.

- To determine whether there is a relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received by patients.

OUTLINE: Patients complete questionnaires (Lickert and QLQ-C30) on the amount of information received prior to therapy and psychosocial issues on aspects of fertility and infertility once within 1-2 years after receiving treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer, germ cell tumor, colon cancer, leukemia, lymphoma, or sarcoma

- Free of disease

- Completed treatment within the past 1-2 years

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Must be able to read and self-complete study questionnaires

- No psychological conditions that may prevent participation in the study

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent treatment (hormonal treatment for breast cancer is allowed)

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• assessment of therapy complications

• fertility assessment and management

• psychosocial assessment and care

• quality-of-life assessment

Locations
Country Name City State
Spain Institut Catala D'Oncologia l'Hospitalet de Llobregat

Sponsors (1)
Lead Sponsor Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of information received on aspects of fertility and infertility No
Primary Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received No
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