Localized Prostate CancerNCT00717613
Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
An observational study of Localized Prostate Cancer, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Convenience sample of men on active surveillance drawn from large academic medical centers, community hospitals, support groups, and the internet.
Who may be able to join
- 1) male,
- 2) 18 years or older, with biopsy-proven prostate cancer,
- 3) diagnosed with localized disease within the last 24 months,
- 4) have a telephone at the time of enrollment,
- 5) have an address where they can receive study materials by mail (a street address or post office box),
- 6) able to speak and understand English;
- 7) have selected surveillance, rather than active treatment for his prostate cancer.
Who cannot join
- 1) female
- 2) no diagnosis of localized prostate cancer
- 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
- 4) no phone or US mail address
- 5) unwilling or unable to provide informed consent
- 6) unable to speak and understand English
Trial locations and contacts
1 site in 1 country.
About this study
This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.
Read the detailed description
Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.
- Conditions
- Localized Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life, particularly cancer-specific anxiety and general anxiety
Measured: One time retrospective interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Latini, Baylor College of Medicine
- Investigators
- David M Latini, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717613
- Sponsor's protocol ID
- DLD2007-01
- Status last verified
- Jan 2018
- First submitted
- 16 Jul 2008
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting
- ClinicalTrials.gov ID
- NCT00717613
- Acronym / sponsor ID
- DLD2007-01
- Conditions
- Localized Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Jul 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.
This study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.
Detailed description
Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Observational cohort study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of men on active surveillance drawn from large academic medical centers, community hospitals, support groups, and the internet.
Key inclusion criteria (7 listed)
- 1) male,
- 2) 18 years or older, with biopsy-proven prostate cancer,
- 3) diagnosed with localized disease within the last 24 months,
- 4) have a telephone at the time of enrollment,
- 5) have an address where they can receive study materials by mail (a street address or post office box),
Key exclusion criteria (6 listed)
- 1) female
- 2) no diagnosis of localized prostate cancer
- 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.)
- 4) no phone or US mail address
- 5) unwilling or unable to provide informed consent
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
Health-related quality of life, particularly cancer-specific anxiety and general anxiety
Time frame: One time retrospective interview
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 23 Jan 2018.
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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.
David M Latini, PhD principal investigator
Baylor College of Medicine
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 Localized Prostate Cancer, run by Baylor College of Medicine 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 7 inclusion and 6 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 23 Jan 2018. 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?
Health-related quality of life, particularly cancer-specific anxiety and general anxiety (time frame: One time retrospective interview). 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 23 Jan 2018.