NCT01295463

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

August 12, 2013

Status Verified

February 1, 2011

Enrollment Period

1.5 years

First QC Date

February 11, 2011

Last Update Submit

August 9, 2013

Conditions

Cancer

Keywords

sexual dysfunctionpsychosocial effects of cancer and its treatmentinfertilitycolon cancermale breast cancerbreast cancergerm cell tumorovarian sarcomauterine sarcomachronic lymphocytic leukemiaosteosarcomachronic myelogenous leukemianon-Hodgkin lymphomaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 leukemiahairy cell leukemiaprolymphocytic leukemiaadult acute lymphoblastic leukemiaadult acute myeloid leukemiaadult Hodgkin lymphomaadult T-cell leukemia/lymphomasmall intestine lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomamycosis fungoides/Sezary syndromeintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomanoncutaneous extranodal lymphomasecondary acute myeloid leukemiaacute undifferentiated leukemiacentral nervous system leukemiaT-cell large granular lymphocyte leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativeclear cell sarcoma of the kidneyKaposi sarcomaadult soft tissue sarcomachronic myelomonocytic leukemiasecondary central nervous system Hodgkin lymphomacutaneous lymphomaadult non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • Amount of information received on aspects of fertility and infertility

  • Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received

Interventions

questionnaire administrationOTHER
study of socioeconomic and demographic variablesOTHER
assessment of therapy complicationsPROCEDURE
fertility assessment and managementPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Catala D'Oncologia

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

MeSH Terms

Conditions

NeoplasmsSexual Dysfunction, PhysiologicalInfertilityColonic NeoplasmsBreast Neoplasms, MaleBreast NeoplasmsNeoplasms, Germ Cell and EmbryonalLeukemia, Lymphocytic, Chronic, B-CellOsteosarcomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLymphoma, Non-HodgkinCongenital AbnormalitiesLeukemia, Mast-CellLeukemia, Hairy CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyMycosis FungoidesSezary SyndromeIntraocular LymphomaLeukemia, Biphenotypic, AcuteLeukemia, Large Granular LymphocyticLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeSarcoma, KaposiSarcomaLeukemia, Myelomonocytic, ChronicLymphoma, T-Cell, Cutaneous

Interventions

TherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesLymphomaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLymphoma, T-CellLymphadenopathyEye NeoplasmsLeukemia, T-CellMyelodysplastic-Myeloproliferative DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Josefina Rivera, RGN, MSN

    Institut Català d'Oncologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2012

Last Updated

August 12, 2013

Record last verified: 2011-02

Locations

ES(1)