GriefNCT00745784
Prolonged Grief in Young Bereaved Spouses and Partners
An observational study of Grief, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of the research is to learn more about the experience of grief in young bereaved spouses/partners. Recent research has shown that young bereaved spouses/partners experience grief uniquely from other age groups, but it is still unclear how certain factors affect the experience of grief. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Grief
- What is being tested?
- in-person or telephone interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Aug 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Only spouses/partners of deceased Calvary and Memorial Sloan Kettering patients will be assessed in this study.
Who may be able to join
- Participants must be at least 20 years old and no older than 49 years and 11 months old.
- Participants must have lost a spouse/domestic partner to cancer 6 months to 3 years earlier.
- Participants must be able to give informed consent.
- Participants must be able to comprehend English to complete study assessments.
Who cannot join
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Calavery Hospital
The Bronx, New York, 10462
About this study
Official title: Lost to Cancer: Prolonged Grief in Young Bereaved Spouses and Partners
The purpose of the research is to learn more about the experience of grief in young bereaved spouses/partners. Recent research has shown that young bereaved spouses/partners experience grief uniquely from other age groups, but it is still unclear how certain factors affect the experience of grief. The investigators research team is interested in studying how the psychological factors of trauma, personality, and meaning of the loss affect grief reactions in young spouses/partners after the loss of a spouse to cancer.
- Conditions
- Grief
- Being tested
- in-person or telephone interview
- Keywords
- Young Bereaved Spouses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-person or telephone interviewBehavioural
Participants will be administered one battery of questionnaires that should take 50- 55 minutes, which may be broken down into two or more segments if necessary. They may choose to have these questionnaires administered to them in person at the hospital, in person at their home, or via telephone by a trained master's level research assistant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Young spouses/domestic partners (20-49 years old) of cancer patients who have died from cancer. Receives: Behavioral: in-person or telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate and levels of prolonged grief in young bereaved spouses/partners of cancer patients
Measured: conclusion of the study
Secondary outcomes (3)
To determine associations among prolonged grief, personality characteristics , previous trauma, & subjective meanings of the loss to the bereaved spouse in young bereaved spouses/partners of cancer
Measured: conclusion of the study
To evaluate whether unique themes emerge among those reporting prolonged grief
Measured: conclusion of the study
To evaluate whether unique themes emerge among those reporting obsessive and histrionic personality traits
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Calvary Hospital, Bronx, NY
- Investigators
- Sherry Schacter, PhD, Principal investigator, Calvary Hospital, Bronx, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745784
- Sponsor's protocol ID
- 08-100
- Status last verified
- Aug 2011
- First submitted
- 2 Sep 2008
- Last updated
- 18 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lost to Cancer: Prolonged Grief in Young Bereaved Spouses and Partners
- ClinicalTrials.gov ID
- NCT00745784
- Acronym / sponsor ID
- 08-100
- Conditions
- Grief
- Keywords
- Young Bereaved Spouses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Calvary Hospital, Bronx, NY
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Sep 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.
The purpose of the research is to learn more about the experience of grief in young bereaved spouses/partners. Recent research has shown that young bereaved spouses/partners experience grief uniquely from other age groups, but it is still unclear how certain factors affect the experience of grief. The investigators research team is interested in studying how the psychological factors of trauma, personality, and meaning of the loss affect grief reactions in young spouses/partners after the loss of a spouse to cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: in-person or telephone interviewYoung spouses/domestic partners (20-49 years old) of cancer patients who have died from cancer. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Only spouses/partners of deceased Calvary and Memorial Sloan Kettering patients will be assessed in this study.
Key inclusion criteria (4 listed)
- Participants must be at least 20 years old and no older than 49 years and 11 months old.
- Participants must have lost a spouse/domestic partner to cancer 6 months to 3 years earlier.
- Participants must be able to give informed consent.
- Participants must be able to comprehend English to complete study assessments.
Key exclusion criteria (1 listed)
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
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 |
|---|---|---|
| in-person or telephone interviewParticipants will be administered one battery of questionnaires that should take 50- 55 minutes, which may be broken down into two or more segments if necessary. They may choose to have these questionnaires administered to them in person at the hospital, in person at their home, or via telephone by a trained master's level research assistant. | Behavioural | 1 |
Primary outcome
To determine the rate and levels of prolonged grief in young bereaved spouses/partners of cancer patients
Time frame: conclusion of the study
3 secondary outcomes
To determine associations among prolonged grief, personality characteristics , previous trauma, & subjective meanings of the loss to the bereaved spouse in young bereaved spouses/partners of cancer
Time frame: conclusion of the study
To evaluate whether unique themes emerge among those reporting prolonged grief
Time frame: conclusion of the study
To evaluate whether unique themes emerge among those reporting obsessive and histrionic personality traits
Time frame: conclusion of the 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 18 Aug 2011.
- 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.
Sherry Schacter, PhD principal investigator
Calvary Hospital, Bronx, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Grief, run by Memorial Sloan Kettering Cancer Center at 2 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?
The sponsor lists 4 inclusion and 1 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 18 Aug 2011. 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. 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 determine the rate and levels of prolonged grief in young bereaved spouses/partners of cancer patients (time frame: conclusion of the study). 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 18 Aug 2011.