Enhanced Self-Efficacy Training

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938769
First received: July 10, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Neoplasms
Other: Self-Efficacy Training for Caregivers
Other: Comparison Conditions for Caregivers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhanced Self-Efficacy Training For Informal Cancer Caregivers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Self-efficacy in symptom management [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological well-being [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Management of psychological distress [ Time Frame: One month ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: August 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Self-Efficacy Training for Caregivers
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

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.

Comparison Conditions for Caregivers
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

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


Detailed Description:

Symptom management is essential in home caregiving. However, many informal caregivers are not confident of their ability to assist their their loved ones with their cancer symptoms at home. A low level of confidence or self-efficacy may negatively affect a caregiver's psychological well-being which is already vulnerable as a consequence of caregiving. Because of the reciprocal nature in a caregiver-patient dyad, caregiver decline is likely associated with patient decline. Improving caregivers' self-efficacy to manage their loved ones' cancer-related symptoms may mitigate their psychological decline and may positively affect patients' well-being by alleviating their symptom distress. Additionally, training in self-management of stress may promote coping among caregivers as many data show that caregiver stress is overwhelming.

This study will examine the effects of an Enhanced Caregiver Training protocol delivered to informal caregivers of cancer patients before hospital discharge. The primary aim is to test the effects of the training on caregivers' self-efficacy in cancer symptom management and self-efficacy in self-management of stress. The study will also look at the effects of this training on caregiver outcomes (depression, anxiety, quality of life, caregiver stress) and patient outcomes (symptom distress and intensity, depression, anxiety, quality of life). The study will use a treatment and attention-control group. 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, whereas subjects in the attention-control group will receive an informational session about cancer and resources for caregiving. Data will be collected before and after the training, and at 2 and 4 weeks after hospital discharge. Descriptive statistics and multivariate analysis including mixed models will be used for data analysis This study could have important implications for the nursing community on how to effectively prepare informal cancer caregivers for home caregiving prior to hospital discharge. The long term goal is to refine and expand the training so that it can be used to teach and support informal caregivers of patients suffering from other chronic illnesses, and to determine the cost-effectiveness of this training.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (patients):

  • Diagnosis of cancer (liquid or solid tumor);
  • Admitted to DUMC's 9100 or 9300 for cancer treatment or related complications;
  • 18 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.

Inclusion Criteria (caregivers):

  • 18 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938769

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: James A Tulsky, MD Duke University School of Nursing
Principal Investigator: Cristina Hendrix, PhD Duke University School of Nursing
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938769     History of Changes
Other Study ID Numbers: Pro00009040, 1P01NR010948-01
Study First Received: July 10, 2009
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
cancer
caregiver
symptom
self management

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014