Enhanced Self-Efficacy Training

Enhanced Self-Efficacy Training For Informal Cancer Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Other: Self-Efficacy Training for Caregivers; Other: Comparison Conditions for Caregivers

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.

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-efficacy in symptom management	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
Psychological well-being	One month
Management of psychological distress	One month
Quality of Life	One month

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: James A Tulsky, MD, Duke University School of Nursing; Principal Investigator: Cristina Hendrix, PhD, Duke University School of Nursing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 13, 2009
• First Posted (Estimate): July 14, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: cancer; self management; caregiver; symptom
• Other Study ID Numbers: Pro00009040; 1P01NR010948-01 (U.S. NIH Grant/Contract)