Colorectal CancerNCT00478010
Making Decisions About Participating in a Cancer Clinical Trial for Patients With Stage II, Stage III, or Stage IV Pancreatic Cancer or Stage III or Stage IV Colon Cancer or Rectal Cancer
A study testing counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care in people with Colorectal Cancer and Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2007to 29 Sep 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Stage II-IV pancreatic cancer
- Stage III-IV colon cancer
- Stage III-IV rectal cancer
- Offered the opportunity to participate in a phase I-III cancer clinical trial and agreed or declined to participate
- First appointment at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins
PATIENT CHARACTERISTICS:
- Able to read English
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Research Participation: Decision Making and Outcomes in Cancer Clinical Trials
RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.
Read the detailed description
OBJECTIVES:
- Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
- Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
- Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.
OUTLINE: This is a cross-sectional study.
Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
- Being tested
- counseling intervention, study of socioeconomic and demographic variables, psychosocial assessment and care, quality-of-life assessment
- Keywords
- psychosocial effects of cancer and its treatment, stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
study of socioeconomic and demographic variablesOther
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.
Participation
Decision satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study start19 Jan 2007
- Primary completion29 Sep 2008
- Study completion29 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Biedrzycki, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478010
- Sponsor's protocol ID
- J0666
- Other IDs
- P30CA006973, JHOC-J0666, CDR0000530879, NA_00003458
- Status last verified
- Aug 2010
- First submitted
- 23 May 2007
- Last updated
- 21 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Participation: Decision Making and Outcomes in Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT00478010
- Acronym / sponsor ID
- J0666
- Keywords
- psychosocial effects of cancer and its treatment, stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jan 2007 (actual)
- Primary completion
- 29 Sep 2008 (actual)
- Study completion
- 29 Sep 2008 (actual)
- First posted
- 24 May 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.
RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.
Detailed description
OBJECTIVES:
- Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
- Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
- Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.
OUTLINE: This is a cross-sectional study.
Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Study design
- Primary purpose
- Health services research
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| counseling intervention | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Participation
Decision satisfaction
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 21 Mar 2019.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Barbara Biedrzycki study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care in people with Colorectal Cancer and Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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 21 Mar 2019. 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?
Participation. 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 21 Mar 2019.