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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295463
First Posted: February 14, 2011
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Cancer Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: assessment of therapy complications Procedure: fertility assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Amount of information received on aspects of fertility and infertility
  • Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received

Estimated Enrollment: 96
Study Start Date: December 2010
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295463


Locations
Spain
Institut Catala D'Oncologia Recruiting
l'Hospitalet de Llobregat, Spain, 08907
Contact: Josefina Rivera, RGN, MSN    34-93-260-7332    jrivera@iconcologia.net   
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
Principal Investigator: Josefina Rivera, RGN, MSN Institut Català d'Oncologia
  More Information

ClinicalTrials.gov Identifier: NCT01295463     History of Changes
Other Study ID Numbers: ICO-FERTI
CDR0000695000 ( Registry Identifier: PDQ (Physician Data Query) )
EU-21105
First Submitted: February 11, 2011
First Posted: February 14, 2011
Last Update Posted: August 12, 2013
Last Verified: February 2011

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction
psychosocial effects of cancer and its treatment
infertility
colon cancer
male breast cancer
breast cancer
germ cell tumor
ovarian sarcoma
uterine sarcoma
chronic lymphocytic leukemia
osteosarcoma
chronic myelogenous leukemia
non-Hodgkin lymphoma
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
mast cell leukemia
hairy cell leukemia
prolymphocytic leukemia
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
adult Hodgkin lymphoma
adult T-cell leukemia/lymphoma
small intestine lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
mycosis fungoides/Sezary syndrome
intraocular lymphoma

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female