Endometrial NeoplasmNCT00750672
Follow-up Care After Treatment for Endometrial Cancer
An observational study of Endometrial Neoplasm, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometrial Neoplasm
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will employ a convenience sample of women with endometrial cancer treated at the Ottawa Hospital Cancer Centre who have been discharged from follow-up after September 2005. Women will be identified from the Cancer Centre health records. The primary care providers will also be identified by health records as provided by the endometrial cancer patient when they registered with the TOHCC.
Who may be able to join
- Participants- women diagnosed with endometrial cancer:
- 18 years of age or older.
- speak English or French
- who have been treated (surgery and/or radiation therapy) at TOH.
- who have been discharged from follow-up in the cancer centre in the past 6 months.
- Participants-primary care provider practitioner:
Show all 9Show fewer
- providing follow-up care to at least one woman with endometrial cancer
- Participants- health care providers at the tertiary centre :
- physicians, nurses or allied health care providers whose primary responsibility are to provide care to women with gynecological cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up After Primary Therapy for Endometrial Cancer; Implementation of a Cancer Care Ontario Guideline: A Pilot Evaluation Study.
The purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. This information will be collected from the perspective of the women themselves, their primary care providers (family physician or gynecologist) and the health care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.
Read the detailed description
Research Question How has this transfer in follow-up care impacted performance indicators?
- Volume of follow-up care transferred
- Percentage of women, who have required a re-entry consultation
- Fiscal implication of this transfer of follow-up care
Patient stakeholders:
- What are women's perceptions of the transition of follow-up care?
- What are women's supportive care needs during the transition of follow-up care and ongoing needs?
Primary Care Practitioner stakeholders:
- What are the primary care practitioners' perceptions of the process of transition of follow-up care?
- What are the primary care practitioners' educational needs?
- What are the primary care practitioners' perceptions of the process of re-entry for in women with suspected recurrence?
Tertiary Centre: Health care providers stakeholders
- What are the perceptions of tertiary health care providers about the transition of follow-up care?
- Conditions
- Endometrial Neoplasm
- Keywords
- Endometrial neoplasia, Follow-up care, survivorship, Primary care provider
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of participants perception
Measured: after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Regional Cancer Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750672
- Sponsor's protocol ID
- OHRI 2008-361
- Other IDs
- 2008361-01H for OHREB
- Status last verified
- Jul 2012
- First submitted
- 9 Sep 2008
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up After Primary Therapy for Endometrial Cancer; Implementation of a Cancer Care Ontario Guideline: A Pilot Evaluation Study.
- ClinicalTrials.gov ID
- NCT00750672
- Acronym / sponsor ID
- OHRI 2008-361
- Conditions
- Endometrial Neoplasm
- Keywords
- Endometrial neoplasia, Follow-up care, survivorship, Primary care provider
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ottawa Regional Cancer Centre
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Sep 2008 (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.
The purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. This information will be collected from the perspective of the women themselves, their primary care providers (family physician or gynecologist) and the health care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.
Detailed description
Research Question How has this transfer in follow-up care impacted performance indicators?
- Volume of follow-up care transferred
- Percentage of women, who have required a re-entry consultation
- Fiscal implication of this transfer of follow-up care
Patient stakeholders:
- What are women's perceptions of the transition of follow-up care?
- What are women's supportive care needs during the transition of follow-up care and ongoing needs?
Primary Care Practitioner stakeholders:
- What are the primary care practitioners' perceptions of the process of transition of follow-up care?
- What are the primary care practitioners' educational needs?
- What are the primary care practitioners' perceptions of the process of re-entry for in women with suspected recurrence?
Tertiary Centre: Health care providers stakeholders
- What are the perceptions of tertiary health care providers about the transition of follow-up care?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will employ a convenience sample of women with endometrial cancer treated at the Ottawa Hospital Cancer Centre who have been discharged from follow-up after September 2005. Women will be identified from the Cancer Centre health records. The primary care providers will also be identified by health records as provided by the endometrial cancer patient when they registered with the TOHCC.
Key inclusion criteria (9 listed)
- Participants- women diagnosed with endometrial cancer:
- Participants-primary care provider practitioner:
- Participants- health care providers at the tertiary centre :
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative description of participants perception
Time frame: after 6 month
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 13 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrial Neoplasm, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 9 inclusion and 0 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 13 Jul 2012. 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 Canada. 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?
Qualitative description of participants perception (time frame: after 6 month). 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 13 Jul 2012.