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Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00770419
First received: October 9, 2008
Last updated: February 1, 2011
Last verified: February 2011

October 9, 2008
February 1, 2011
May 2008
January 2010   (final data collection date for 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. [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Relationship between patient's sense of being a burden on the primary caregiver and increases in patient desire for hastened death (DHD) over time as measured by CDS at baseline and the SAHD at 2 and 4 months [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00770419 on ClinicalTrials.gov Archive Site
Identification of coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Caregivers and patients with late-stage oncological disease.

  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Depression
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00770419
CDR0000597594, P30CA072720, CINJ-130601, CINJ-IRB-0220080083
Yes
Patrick-Miller, Linda, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Linda Patrick-Miller, PhD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP