Cervical CancerNCT00581646
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
An observational study of Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Leukemia
- What is being tested?
- survey instrument
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Cervical cancer, Endometrial cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine cancer, Vaginal cancer survivors and non-cancer infertile women
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- Inability to participate in an informed consent process
- Patients with a psychiatric disorder precluding response to the survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cervical Cancer, Endometrial Cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine Cancer, Vaginal Cancer
- Being tested
- survey instrument
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Leukemia, Lymphoma, Non-Hodgkin, Uterine Neoplasms, Vaginal Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey instrumentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | gynecologic cancer survivors Receives: Behavioral: survey instrument | |
| 2 | survivors of any type of malignancy with history of BMT/SCT Receives: Behavioral: survey instrument | |
| 3 | non-cancer infertile women awaiting third party reproduction Receives: Behavioral: survey instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Jeanne Carter, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581646
- Sponsor's protocol ID
- 06-110
- Status last verified
- Jul 2015
- First submitted
- 21 Dec 2007
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
- ClinicalTrials.gov ID
- NCT00581646
- Acronym / sponsor ID
- 06-110
- Conditions
- Cervical Cancer, Endometrial Cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine Cancer, Vaginal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Study start
- Sep 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: survey instrumentgynecologic cancer survivors |
| 2 | – | Behavioral: survey instrumentsurvivors of any type of malignancy with history of BMT/SCT |
| 3 | – | Behavioral: survey instrumentnon-cancer infertile women awaiting third party reproduction |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cervical cancer, Endometrial cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine cancer, Vaginal cancer survivors and non-cancer infertile women
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to participate in an informed consent process
- Patients with a psychiatric disorder precluding response to the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey instrumentParticipants 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. | Behavioural | 1, 2, 3 |
Primary outcome
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
Time frame: 2 years
2 secondary outcomes
Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)
Time frame: 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
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Carter, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.