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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00770419
Other study ID # 130601
Secondary ID P30CA072720CDR00
Status Withdrawn
Phase N/A
First received October 9, 2008
Last updated May 27, 2015
Start date May 2008
Est. completion date February 2010

Study information

Verified date May 2015
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
medical chart review

questionnaire administration

Procedure:
psychosocial assessment and care


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Primary 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 No
Secondary Identification of coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD No
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