Enhanced Self-Efficacy Training

Neoplasms Clinical Trial

Official title:

Enhanced Self-Efficacy Training For Informal Cancer Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938769
• Other study ID #: Pro00009040
• Secondary ID: 1P01NR010948-01
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: February 6, 2014
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: February 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neoplasms

Intervention

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 caregiving. 2-hour counseling session for cancer caregivers to locate community support resources

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy in symptom management		One month	No
Secondary	Psychological well-being		One month	No
Secondary	Management of psychological distress		One month	No
Secondary	Quality of Life		One month	No