NCT00938769

Brief Summary

The goal of this study is to examine the effects of an enhanced caregiver training protocol that not only teaches informal caregivers knowledge and skills for managing patient symptoms, but also provides strategies for managing their own psychological distress. The investigators anticipate this training will increase caregivers' self-efficacy and improve important caregiver outcomes (depression, anxiety, burden, quality of life) and patient outcomes (symptom distress/intensity, depression, anxiety, and quality of life). The study will compare the effects of this protocol to an education control condition that equates for interventionist time and attention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

4.1 years

First QC Date

July 10, 2009

Last Update Submit

February 6, 2014

Conditions

Neoplasms

Keywords

cancercaregiversymptomself management

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy in symptom management

    One month

Secondary Outcomes (3)

  • Psychological well-being

    One month

  • Management of psychological distress

    One month

  • Quality of Life

    One month

Study Arms (2)

Self-Efficacy Training for Caregivers

OTHER

The Enhanced Caregiver Training intervention will be delivered to informal caregivers of cancer patients before hospital discharge who are randomly selected to receive this intervention. Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress.

Other: Self-Efficacy Training for Caregivers

Comparison Conditions for Caregivers

OTHER

Subjects randomly selected to participate in the attention control training will receive an informational session about cancer and resources for support.

Other: Comparison Conditions for Caregivers

Interventions

Self-Efficacy Training for CaregiversOTHER

The Enhanced Caregiver Training intervention will be delivered to informal caregivers of cancer patients before hospital discharge who are randomly selected to receive this intervention. Subjects in the treatment group will receive an individualized experiential caregiver training in strategies for managing patient's symptoms and in the use of pleasant imagery and muscle relaxation to manage stress. 2-hour in-person instruction of home care issues for caregivers of patients with cancer.

Self-Efficacy Training for Caregivers
Comparison Conditions for CaregiversOTHER

Subjects randomly selected to participate in the attention control training will receive an informational session about cancer and resources for caregiving. 2-hour counseling session for cancer caregivers to locate community support resources

Comparison Conditions for Caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cancer (liquid or solid tumor);
  • Admitted to DUMC's 9100 or 9300 for cancer treatment or related complications;
  • years of age or older;
  • Able to read, speak and write in English;
  • Anticipates being discharged to home;
  • Not referred to hospice;
  • Will have home care needs after discharge;
  • No major cognitive impairment;
  • Has caregiver willing to do study training and surveys.
  • years of age or older;
  • Able to read, speak and write in English;
  • Interacts with, and provides most of the hands-on care to, patient who meets above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Hendrix CC, Bailey DE Jr, Steinhauser KE, Olsen MK, Stechuchak KM, Lowman SG, Schwartz AJ, Riedel RF, Keefe FJ, Porter LS, Tulsky JA. Effects of enhanced caregiver training program on cancer caregiver's self-efficacy, preparedness, and psychological well-being. Support Care Cancer. 2016 Jan;24(1):327-336. doi: 10.1007/s00520-015-2797-3. Epub 2015 Jun 12.

    PMID: 26062925DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • James A Tulsky, MD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

  • Cristina Hendrix, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

US(1)