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

Primary Purpose

Cancer

Status
Unknown status
Phase
Locations
Spain
Study Type
Observational
Intervention
questionnaire administration
study of socioeconomic and demographic variables
assessment of therapy complications
fertility assessment and management
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cancer focused on measuring 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, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma, noncutaneous extranodal lymphoma, secondary acute myeloid leukemia, acute undifferentiated leukemia, central nervous system leukemia, T-cell large granular lymphocyte leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, clear cell sarcoma of the kidney, Kaposi sarcoma, adult soft tissue sarcoma, chronic myelomonocytic leukemia, secondary central nervous system Hodgkin lymphoma, cutaneous lymphoma, adult non-Hodgkin lymphoma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut Catala D'OncologiaRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2011
Last Updated
August 9, 2013
Sponsor
Institut Català d'Oncologia
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1. Study Identification

Unique Protocol Identification Number
NCT01295463
Brief Title
Study of Information Received About Fertility and Infertility in Patients Who Have Finished Treatment for Cancer
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
Study Type
Observational

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Català d'Oncologia

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
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, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma, noncutaneous extranodal lymphoma, secondary acute myeloid leukemia, acute undifferentiated leukemia, central nervous system leukemia, T-cell large granular lymphocyte leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, clear cell sarcoma of the kidney, Kaposi sarcoma, adult soft tissue sarcoma, chronic myelomonocytic leukemia, secondary central nervous system Hodgkin lymphoma, cutaneous lymphoma, adult non-Hodgkin lymphoma

7. Study Design

Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Type
Procedure
Intervention Name(s)
fertility assessment and management
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Amount of information received on aspects of fertility and infertility
Title
Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josefina Rivera, RGN, MSN
Organizational Affiliation
Institut Català d'Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Catala D'Oncologia
City
l'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Rivera, RGN, MSN
Phone
34-93-260-7332
Email
jrivera@iconcologia.net

12. IPD Sharing Statement

Learn more about this trial

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

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