CancerNCT01295463
Study of Information Received About Fertility and Infertility in Patients Who Have Finished Treatment for Cancer
An observational study of Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cancer
- What is being tested?
- questionnaire administration, study of socioeconomic and demographic variables and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2010to Jun 2012
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
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)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut Catala D'Oncologia
L'Hospitalet de Llobregat, 08907
Josefina Rivera, RGN, MSN, 34-93-260-7332, jrivera@iconcologia.net
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- questionnaire administration, study of socioeconomic and demographic variables, assessment of therapy complications, fertility assessment and management, psychosocial assessment and care
- 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
- Medical subject headings
- Neoplasms, Sexual Dysfunction, Physiological, Infertility, Colonic Neoplasms, Breast Neoplasms, Male, Breast Neoplasms, Neoplasms, Germ Cell and Embryonal, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
assessment of therapy complicationsProcedure or surgery
fertility assessment and managementProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of information received on aspects of fertility and infertility
Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Investigators
- Josefina Rivera, RGN, MSN, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295463
- Sponsor's protocol ID
- ICO-FERTI
- Other IDs
- CDR0000695000, EU-21105
- Status last verified
- Feb 2011
- First submitted
- 11 Feb 2011
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01295463
- Acronym / sponsor ID
- ICO-FERTI
- Conditions
- Cancer
- Keywords
- sexual dysfunction, psychosocial effects of cancer and its treatment, infertility, colon cancer, male breast cancer, breast cancer, germ cell tumor, ovarian sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (estimated)
- First posted
- 14 Feb 2011 (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.
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.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| fertility assessment and management | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Amount of information received on aspects of fertility and infertility
Relationship between demographic data, diagnosis, quality of life, and associated psychosocial information received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Josefina Rivera, RGN, MSN principal investigator
Institut Català d'Oncologia
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 Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of information received on aspects of fertility and infertility. The study lists 2 primary outcomes in all. 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 12 Aug 2013.