Advanced CancerNCT00543153
The Exceptional Patient in Cancer Care
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
Trial summary
The objectives of this study is to conduct a multicenter, dual country (United States and Israel), study examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2007to Aug 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: Patients, 18 years of age or older, dianosed with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
Who may be able to join
- 18 years of age or older
- Ability to speak and read English with patients residing in the US, ability to speak and read Hebrew with patients residing in Israel.
- Diagnosis of cancer confirmed by pathology.
- Exceptional disease course as identified by patients' physician, in terms of survival and unusual disease course that is appropriately medically documented.
- Consent to participate in this study.
Who cannot join
- Inability to understand the intent of the study.
- Medical condition that would preclude participation in an interview session lasting 30-45 minutes.
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The objectives of this study is to conduct a multicenter, dual country (United States and Israel), study examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
The primary aim of the study is to develop a detailed description of patients' experience of an exceptional disease course. The secondary aim is to define the content domain for assessment and measurement of exceptional disease course in patients with cancer and identify lessons learned from these exceptional patients that can be a base for future studies to benefit others.
Read the detailed description
The investigators of this study are exploring the experience of people with cancer who are considered by their physicians as having an exceptional course of disease - people who have defied the odds and remain well despite the severity of the original diagnosis.
Participation in this study is completely voluntary. Lessons learned from recorded experience(s) may be helpful to other patients and can be a basis for future studies that may benefit other patients.
To participate in this important study is simple and not time consuming. You will have only one face-to-face or telephone interview with a research assistant. During the interview you will simply be asked to describe your perspective, thoughts, and behaviors that you think are related to your disease course and lessons that you think others may gain benefit from. The interview will last about one hour and will be conducted at a time that is convenient for you.
If you agree to participate a research assistant will schedule a time for a recorded interview by phone or if possible at a location convenient to you. The interviews will be taped and transcribed. All recorded interviews will be retained for a minimum of 6 years.
- Conditions
- Advanced Cancer
- Being tested
- Interview
- Keywords
- Advanced Cancer, Exceptional Patient, Cancer Care, Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Interview lasting approximately 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with cancer | Not described Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe A. Frenkel, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543153
- Sponsor's protocol ID
- 2007-0435
- Status last verified
- Jul 2012
- First submitted
- 11 Oct 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frenkel M, Ari SL, Engebretson J, Peterson N, Maimon Y, Cohen L, Kacen L. Activism among exceptional patients with cancer. Support Care Cancer. 2011 Aug;19(8):1125-32. doi: 10.1007/s00520-010-0918-6. Epub 2010 May 29.
PubMed 20512358
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exceptional Patient in Cancer Care
- ClinicalTrials.gov ID
- NCT00543153
- Acronym / sponsor ID
- 2007-0435
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Exceptional Patient, Cancer Care, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Oct 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.
The objectives of this study is to conduct a multicenter, dual country (United States and Israel), study examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
The primary aim of the study is to develop a detailed description of patients' experience of an exceptional disease course. The secondary aim is to define the content domain for assessment and measurement of exceptional disease course in patients with cancer and identify lessons learned from these exceptional patients that can be a base for future studies to benefit others.
Detailed description
The investigators of this study are exploring the experience of people with cancer who are considered by their physicians as having an exceptional course of disease - people who have defied the odds and remain well despite the severity of the original diagnosis.
Participation in this study is completely voluntary. Lessons learned from recorded experience(s) may be helpful to other patients and can be a basis for future studies that may benefit other patients.
To participate in this important study is simple and not time consuming. You will have only one face-to-face or telephone interview with a research assistant. During the interview you will simply be asked to describe your perspective, thoughts, and behaviors that you think are related to your disease course and lessons that you think others may gain benefit from. The interview will last about one hour and will be conducted at a time that is convenient for you.
If you agree to participate a research assistant will schedule a time for a recorded interview by phone or if possible at a location convenient to you. The interviews will be taped and transcribed. All recorded interviews will be retained for a minimum of 6 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with cancer | – | Behavioral: Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, 18 years of age or older, dianosed with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
Key inclusion criteria (5 listed)
- 18 years of age or older
- Ability to speak and read English with patients residing in the US, ability to speak and read Hebrew with patients residing in Israel.
- Diagnosis of cancer confirmed by pathology.
- Exceptional disease course as identified by patients' physician, in terms of survival and unusual disease course that is appropriately medically documented.
- Consent to participate in this study.
Key exclusion criteria (3 listed)
- Inability to understand the intent of the study.
- Medical condition that would preclude participation in an interview session lasting 30-45 minutes.
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
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 |
|---|---|---|
| InterviewInterview lasting approximately 30-45 minutes. | Behavioural | Patients diagnosed with cancer |
Primary outcome
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
Time frame: 2 Years
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 30 Jul 2012.
- Results publication: PubMed 20512358Frenkel M, Ari SL, Engebretson J, Peterson N, Maimon Y, Cohen L, Kacen L. Activism among exceptional patients with cancer. Support Care Cancer. 2011 Aug;19(8):1125-32. doi: 10.1007/s00520-010-0918-6. Epub 2010 May 29.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Moshe A. Frenkel, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
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 5 inclusion and 3 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 30 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 2 sites in United States, Israel. 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 Data Collection: Patients' Experience of Exceptional Disease Course (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00543153, which also lists 1 linked publication.
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 30 Jul 2012.