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Enhanced Self-Efficacy Training For Informal Cancer Caregivers

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Enhanced Self-Efficacy Training For Informal Cancer Caregivers

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.

Inclusion 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

Type of Study:


Study Design:

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

Outcome Measure:

Self-efficacy in symptom management

Outcome Time Frame:

One month

Safety Issue:


Principal Investigator

James A Tulsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University School of Nursing


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

July 2013

Related Keywords:

  • Neoplasms
  • cancer
  • caregiver
  • symptom
  • self management
  • Neoplasms



Duke University Medical Center Durham, North Carolina  27710