Advanced CancerNCT00581880
Measuring Hope and Hopelessness in Cancer
An observational study of Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University… 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?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2009
- 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: Subjects will be recruited in equal numbers from Memorial Hospital and Calvary Hospital or Peter MacCallum Cancer Centre at each stage of data collection.
Who may be able to join
- 18 years of age or older.
- Patients who are able to understand verbal and written English.
- Diagnosis of cancer.
- Patients with advanced cancer receiving ambulatory or inpatient care at Memorial Sloan-Kettering Cancer Center in New York City. Patients at Calvary Hospital and Peter MacCallum Cancer Centre admitted for palliative care will also be eligible for participation in this study
Who cannot join
- The presence of a psychotic mental disorder (e.g., Bipolar Disorder, Schizophrenia, Schizo-affective illness, psychosis due to substance abuse) as indicated in medical chart.
- Cognitive impairment so severe (i.e., Mini-Mental State exam score of less than 20) that, in the opinion of the Principal Investigator or Project Coordinator, would interfere with a patient's ability to give informed consent for research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University are working together to design a new measure. Findings from this research will help us study the nature of illness and develop improved methods of diagnosis and treatment. We hope what we learn from you will help us learn more about how to care better for patients with cancer and other severe illnesses.
- Conditions
- Advanced Cancer
- Being tested
- questionnaires
- Keywords
- end stage, Terminally Ill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
A battery of questionnaires concerning your thoughts, opinions, and attitudes about your illness and outlook on life. In addition, we will ask to provide some background information about you and your illness. The questions will take approximately 30 to 45 minutes to complete. You fill out the questionnaire once only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Terminally Ill patients Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore and better understand the construct of hopelessness as it applies to terminally ill cancer patients.
Measured: conclusion of study
To develop a brief self-report measure of hopelessness grounded in the construct of hopelessness as it applies to terminally ill cancer patients.
Measured: conclusion of study
Secondary outcomes (1)
To establish the reliability and validity of this newly developed measure of hopelessness in a large sample of terminally ill cancer patients.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University, Calvary Hospital, Bronx, NY, Peter MacCallum Cancer Centre, Australia
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581880
- Sponsor's protocol ID
- 04-145
- Status last verified
- Jan 2009
- First submitted
- 21 Dec 2007
- Last updated
- 15 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Hope and Hopelessness in Cancer
- ClinicalTrials.gov ID
- NCT00581880
- Acronym / sponsor ID
- 04-145
- Conditions
- Advanced Cancer
- Keywords
- end stage, Terminally Ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fordham University, Calvary Hospital, Bronx, NY, Peter MacCallum Cancer Centre, Australia
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Dec 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 purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University are working together to design a new measure. Findings from this research will help us study the nature of illness and develop improved methods of diagnosis and treatment. We hope what we learn from you will help us learn more about how to care better for patients with cancer and other severe illnesses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnairesTerminally Ill patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited in equal numbers from Memorial Hospital and Calvary Hospital or Peter MacCallum Cancer Centre at each stage of data collection.
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Patients who are able to understand verbal and written English.
- Diagnosis of cancer.
- Patients with advanced cancer receiving ambulatory or inpatient care at Memorial Sloan-Kettering Cancer Center in New York City. Patients at Calvary Hospital and Peter MacCallum Cancer Centre admitted for palliative care will also be eligible for participation in this study
Key exclusion criteria (2 listed)
- The presence of a psychotic mental disorder (e.g., Bipolar Disorder, Schizophrenia, Schizo-affective illness, psychosis due to substance abuse) as indicated in medical chart.
- Cognitive impairment so severe (i.e., Mini-Mental State exam score of less than 20) that, in the opinion of the Principal Investigator or Project Coordinator, would interfere with a patient's ability to give informed consent for research.
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 |
|---|---|---|
| questionnairesA battery of questionnaires concerning your thoughts, opinions, and attitudes about your illness and outlook on life. In addition, we will ask to provide some background information about you and your illness. The questions will take approximately 30 to 45 minutes to complete. You fill out the questionnaire once only. | Behavioural | 1 |
Primary outcome
To explore and better understand the construct of hopelessness as it applies to terminally ill cancer patients.
Time frame: conclusion of study
To develop a brief self-report measure of hopelessness grounded in the construct of hopelessness as it applies to terminally ill cancer patients.
Time frame: conclusion of study
1 secondary outcome
To establish the reliability and validity of this newly developed measure of hopelessness in a large sample of terminally ill cancer patients.
Time frame: conclusion of study
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 15 Jan 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
William Breitbart, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Advanced Cancer, run by Memorial Sloan Kettering Cancer Center 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 4 inclusion and 2 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 15 Jan 2009. 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?
To explore and better understand the construct of hopelessness as it applies to terminally ill cancer patients. (time frame: conclusion of study). 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 15 Jan 2009.