Psychosocial Effects of Cancer and Its TreatmentNCT00054223
Study of Decision Making in Patients Participating in Phase I Clinical Trials
A study testing psychosocial assessment and care in people with Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 5 sites in United States.
Trial summary
RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted. PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2003to Nov 2005
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Consented to enrollment in a phase I cancer clinical trial
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Understands written English
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent enrollment in other clinical trials evaluating phase I patient attitudes
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official title: Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.
PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.
Read the detailed description
OBJECTIVES:
- Determine the range of personality traits of patients enrolled in a phase I clinical trial.
- Determine these patients' understanding of their medical situation and prognosis.
- Determine these patients' understanding of risks and benefits of phase I clinical trials.
- Determine these patients' reasons for participating in a phase I clinical trial.
- Determine the risk/benefit trade-offs of these patients.
- Determine the existential outlook of these patients.
- Determine the information gathering nature of these patients.
OUTLINE: This is a multicenter study.
Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.
PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startJan 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial Effects of Cancer and Its TreatmentStudies 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
- Interventional
- Phase
- Phase N/A
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Manish Agrawal, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054223
- Sponsor's protocol ID
- 030063
- Other IDs
- 03-CC-0063, CDR0000269911
- Status last verified
- Mar 2012
- First submitted
- 5 Feb 2003
- Last updated
- 16 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
- ClinicalTrials.gov ID
- NCT00054223
- Acronym / sponsor ID
- 030063
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Feb 2003 (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: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.
PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.
Detailed description
OBJECTIVES:
- Determine the range of personality traits of patients enrolled in a phase I clinical trial.
- Determine these patients' understanding of their medical situation and prognosis.
- Determine these patients' understanding of risks and benefits of phase I clinical trials.
- Determine these patients' reasons for participating in a phase I clinical trial.
- Determine the risk/benefit trade-offs of these patients.
- Determine the existential outlook of these patients.
- Determine the information gathering nature of these patients.
OUTLINE: This is a multicenter study.
Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.
PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.
Study design
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 16 Mar 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.
Manish Agrawal, MD study chair
National Cancer Institute (NCI)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial assessment and care in people with Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 5 sites 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?
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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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 16 Mar 2012.