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

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ClinicalTrials.gov Identifier: NCT00770419
Recruitment Status : Withdrawn (Slow accrual)
First Posted : October 10, 2008
Last Update Posted : May 29, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date October 9, 2008
First Posted Date October 10, 2008
Last Update Posted Date May 29, 2015
Study Start Date May 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2008)
  • 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
Original Primary Outcome Measures
 (submitted: October 9, 2008)
  • 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
  • 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
Change History Complete list of historical versions of study NCT00770419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 9, 2008)
Identification of coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers
Official Title Perception of Caregiver Burden
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Caregivers and patients with late-stage oncological disease.
Condition
  • 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
Intervention
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: February 1, 2011)
0
Original Estimated Enrollment
 (submitted: October 9, 2008)
116
Actual Study Completion Date February 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00770419
Other Study ID Numbers 130601
P30CA072720 ( U.S. NIH Grant/Contract )
CDR0000597594
CINJ-IRB-0220080083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor Rutgers, The State University of New Jersey
Collaborators
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Linda Patrick-Miller, PhD Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2015