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Study Summary
No. 2007-0392:.......Other Supportive......Eduardo Bruera......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:
2007-0392
Study Title:Hypodermoclysis Performed by Caregivers in Home Hospice Settings
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Physician New Patient Referral
Name:Eduardo BrueraPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Other SupportiveSupported By:N/A
Phase of Study:N/AReturn
Visit:
Home hospice patients who are not required to come to M.D. Anderson.
Treatment
Agents:
SalineHome Care:The research nurses of protocol 2006-0494 will teach and monitor caregivers'
ability of performing hypodermoclysis in home hospice settings.
Treatment Loc:Only outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
This study will be conducted in home hospice settings.
Description/
Intervention:
The goal of this clinical research study is to learn if caregivers are able to
give fluids under the skin at home.
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Study Objectives / Outcomes

The purpose of this exploratory prospective study is to determine if caregivers are capable of maintaining hypodermoclysis in patients under home hospice care. In addition, this Study will also be an extension study of protocol 2006-0494 "Parenteral Hydration in Advanced Cancer Patients – A Randomized Control Trial." The parent protocol is funded by NIH grant R01-CA122292-01 and is being conducted by our group.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:08/24/2007
Study Type:Other
Recruitment Status:Closed
Projected Accrual:108 (54 patient-caregiver dyads)
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must have successfully completed a 2-week study on protocol 2006-0494, in which patient received either 1,000 ml or 100 ml normal saline daily for 14 days.

2) Patients must be willing to continue receiving fluids and sign the informed consent. If patients are unresponsive and unable to give consent, the caregivers wish to continue the fluid because they perceive that the patient will be more comfortable, a proxy consent will be given by the person holding power of attorney or a legally authorized representative. i.e. if the power of attorney or a legally authorized representative is the son, the son will give consent, and the wife, as primary caregiver, will give fluids.

3) Patients must continue to have a primary caregiver who is a spouse, parent, sibling, adult child, relative or significant other.

4) The primary caregiver must be willing to be trained and to give fluids.

5) The primary caregiver must reside with the patient and be responsible for the care. If the primary caregiver who currently does not reside with the patient, but is willing to visit patient daily, and conduct all necessary interventions and assessments required by the study will also be eligible for the study.

6) The primary caregiver must sign informed consent to participate in the study.

7) The primary caregiver must meet a competency checklist of performing subcutaneous hydration.

Exclusion Criteria:1) 1. Patients who are continuing hospice care in an inpatient facility after completion of previous hydration study (2006-0494) and the inpatient facility is unable or unwilling to allow the patient to continue receiving fluids.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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