NCT00770419

Brief 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. PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage cancer and their caregivers.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

October 9, 2008

Last Update Submit

May 27, 2015

Conditions

Brain and Central Nervous System TumorsChronic Myeloproliferative DisordersDepressionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsPsychosocial Effects of Cancer and Its TreatmentUnspecified Adult Solid Tumor, Protocol Specific

Keywords

depressionpsychosocial effects of cancer and its treatmentunspecified adult solid tumor, protocol specificacute undifferentiated leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 negativechronic myelomonocytic leukemiamast cell leukemiameningeal chronic myelogenous leukemiaprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiaT-cell large granular lymphocyte leukemiaAIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related lymphoblastic lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaAIDS-related small noncleaved cell lymphomaHIV-associated Hodgkin lymphomarecurrent adult Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomacutaneous B-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromeadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomachronic eosinophilic leukemiachronic neutrophilic leukemiaprimary myelofibrosisprimary systemic amyloidosisrefractory multiple myelomapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiable

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

medical chart reviewOTHER
questionnaire administrationOTHER
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Nervous System NeoplasmsMyeloproliferative DisordersDepressionLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Myelomonocytic, ChronicLeukemia, Mast-CellLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticHodgkin DiseaseLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellIntraocular LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicPrimary MyelofibrosisImmunoglobulin Light-chain Amyloidosis

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBehavioral SymptomsBehaviorNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, B-CellLeukemia, T-CellLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Linda Patrick-Miller, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

May 29, 2015

Record last verified: 2015-05