Brain and Central Nervous System TumorsNCT00770419
Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Rutgers, The State University of New Jersey.
Trial summary
RATIONALE: Gathering information over time about patients' sense of being a burden on their caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about the desire to die in patients with late-stage cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Depression
- What is being tested?
- medical chart review, questionnaire administration and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Feb 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: Caregivers and patients with late-stage oncological disease.
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria
- Patient with a diagnosis of cancer
- Confirmed late-stage disease refractory to standard primary therapy
- Reside with a non-paid primary caregiver
- Receiving care at the Cancer Institute of New Jersey
- Caregiver
- Must be at least 18 years old
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 4 months
- No documented or observable cognitive (e.g., dementia) or psychiatric (e.g., psychosis) problems that would interfere with study participation
- Able to read and write English (patient and caregiver)
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Perception of Caregiver Burden
RATIONALE: Gathering information over time about patients' sense of being a burden on their caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about the desire to die in patients with late-stage cancer.
PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage cancer and their caregivers.
Read the detailed description
OBJECTIVES:
Primary
- To measure psychosocial correlates of desire for hastened death (DHD) and change in DHD in patients with late-stage cancer by examining the relationship among a patient's perception of being a burden, their caregiver's perceptions of the patient's burdensomeness, and DHD changes over time.
Secondary
- To identify coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD.
OUTLINE: Patients and caregiver dyads complete questionnaires at baseline, 2 months, and 4 months. The dyads complete demographic questionnaire, the Hospital Anxiety and Depression Scale (HADS), the Beck Hopelessness Scale (BHS), the Dyadic Adjustment Scale (DAS), and the Life Orientation Test-Revised (LOT-R). Patients also complete the Schedule of Attitudes Toward Hastened Death (SAHD), the Brief Coping Orientation to Problems Experienced (Brief COPE), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), and the Caregiver Demands Scale (CDS). Caregivers also complete the Katz Index of Independence in Activities of Daily Living (IADL).
Patients' medical charts are reviewed for stage and node status at primary diagnosis, previous oncology surgeries, previous adjuvant treatments, treatment at time of recurrence, disease free interval, site of metastasis, and response to current treatment.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Depression, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- medical chart review, questionnaire administration, psychosocial assessment and care
- Keywords
- depression, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL negative, chronic myelomonocytic leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia, prolymphocytic leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent adult T-cell leukemia/lymphoma, refractory chronic lymphocytic leukemia
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Depression, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
questionnaire administrationOther
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between patient's sense of being a burden on primary caregiver & increase in patient desire for hastened death (DHD) by Caregiver Demands Scale (CDS) at baseline & Schedule of Attitudes toward Hastened Death (SAHD) at 2 & 4 mo.
Contribution of the caregiver's sense of caregiver burden, as measured by the caregiver version of the CDS at baseline, on increases in patient DHD over time
Secondary outcomes (1)
Identification of coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionFeb 2010
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Linda Patrick-Miller, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770419
- Sponsor's protocol ID
- 130601
- Other IDs
- P30CA072720, CDR0000597594, CINJ-IRB-0220080083
- Status last verified
- May 2015
- First submitted
- 9 Oct 2008
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Caregiver Burden
- ClinicalTrials.gov ID
- NCT00770419
- Acronym / sponsor ID
- 130601
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Depression, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- depression, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Oct 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.
RATIONALE: Gathering information over time about patients' sense of being a burden on their caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about the desire to die in patients with late-stage cancer.
PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage cancer and their caregivers.
Detailed description
OBJECTIVES:
Primary
- To measure psychosocial correlates of desire for hastened death (DHD) and change in DHD in patients with late-stage cancer by examining the relationship among a patient's perception of being a burden, their caregiver's perceptions of the patient's burdensomeness, and DHD changes over time.
Secondary
- To identify coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD.
OUTLINE: Patients and caregiver dyads complete questionnaires at baseline, 2 months, and 4 months. The dyads complete demographic questionnaire, the Hospital Anxiety and Depression Scale (HADS), the Beck Hopelessness Scale (BHS), the Dyadic Adjustment Scale (DAS), and the Life Orientation Test-Revised (LOT-R). Patients also complete the Schedule of Attitudes Toward Hastened Death (SAHD), the Brief Coping Orientation to Problems Experienced (Brief COPE), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), and the Caregiver Demands Scale (CDS). Caregivers also complete the Katz Index of Independence in Activities of Daily Living (IADL).
Patients' medical charts are reviewed for stage and node status at primary diagnosis, previous oncology surgeries, previous adjuvant treatments, treatment at time of recurrence, disease free interval, site of metastasis, and response to current treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers and patients with late-stage oncological disease.
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 |
|---|---|---|
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Relationship between patient's sense of being a burden on primary caregiver & increase in patient desire for hastened death (DHD) by Caregiver Demands Scale (CDS) at baseline & Schedule of Attitudes toward Hastened Death (SAHD) at 2 & 4 mo.
Contribution of the caregiver's sense of caregiver burden, as measured by the caregiver version of the CDS at baseline, on increases in patient DHD over time
1 secondary outcome
Identification of coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
Linda Patrick-Miller, PhD principal investigator
Rutgers Cancer Institute of New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Rutgers, The State University of New Jersey.
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: withdrawn, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Relationship between patient's sense of being a burden on primary caregiver & increase in patient desire for hastened death (DHD) by Caregiver Demands Scale (CDS) at baseline & Schedule of Attitudes toward Hastened Death (SAHD) at 2 & 4 mo.. 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 29 May 2015.