- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00581646
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
7. juli 2015 opdateret af: Memorial Sloan Kettering Cancer Center
Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
This study aims to learn about the needs and feelings of women who are infertile.
Being infertile means not being able to have a child without the help of a third party.
There are other options for building a family.
The researchers are interested in the participants' thoughts about these options and want to learn about the experiences of infertile women due to cancer treatment as well as women who are infertile due to other causes.
The researchers hope that what they learn will allow them to better care for infertile women in the future.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
As part of this study, you will be asked to fill out a series of questionnaires.
These questions will ask about your feelings, sexual function, quality of life, and ideas about reproductive options.
We will also ask some questions about you, your health, and your medical history.
You can choose to answer these questions either at one of your doctor visits or over the telephone.
You can decide the best way to complete this assessment.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
179
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 49 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Cervical cancer, Endometrial cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine cancer, Vaginal cancer survivors and non-cancer infertile women
Beskrivelse
Inclusion Criteria:
Study group of gynecologic cancer survivors and BMT/SMT cancer survivors:
- History of a primary diagnosis of gynecologic cancer or history of any primary malignancy treated with BMT/SCT
- No evidence of disease for at least one year
- At least 18 years of age not greater than 49 years of age at time of study recruitment
- No other cancer history
- Have impaired fertility: lack of uterus but intact ovaries or lack of ovaries or lack of ovarian function based on the FSH determination but intact uterus
- Have not started or have not completed childbearing
- Able and willing to provide informed consent
- Ability to comprehend and complete questionnaire in English
Comparison Group of non-cancer infertile women awaiting egg (oocyte) donation:
- No cancer history
- At least 18 years of age not greater than 49 years of age at time of study recruitment
- In ovarian failure and on a waiting list for egg (oocyte) donation
- Have not started or have not completed childbearing
- Able and willing to provide informed consent
- Ability to comprehend and complete questionnaire in English
Exclusion Criteria:
- Inability to participate in an informed consent process
- Patients with a psychiatric disorder precluding response to the survey
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
1
gynecologic cancer survivors
|
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone.
We expect the study survey to take approximately 35-45 minutes to complete.
The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
|
2
survivors of any type of malignancy with history of BMT/SCT
|
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone.
We expect the study survey to take approximately 35-45 minutes to complete.
The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
|
3
non-cancer infertile women awaiting third party reproduction
|
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone.
We expect the study survey to take approximately 35-45 minutes to complete.
The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Investigate emotional, sexual functioning, reproductive concerns and QOL experience of 3 groups of infertile women: gynecologic cancer survivors, survivors of hematological malignancies, & the non-cancer infertile women awaiting 3rd party reproduction
Tidsramme: 2 years
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)
Tidsramme: 2 years
|
2 years
|
Compare the main domains of depression, distress, sexual functioning and overall QOL of the gynecologic cancer survivors and survivors of a hematological malignancy with history of BMT/SCT to non-cancer infertile women awaiting third party reproduction
Tidsramme: 2 years
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jeanne Carter, PhD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
21. december 2007
Først indsendt, der opfyldte QC-kriterier
21. december 2007
Først opslået (Skøn)
28. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-110
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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