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Completed

NCT Number: NCT00938769

Enhanced Self-Efficacy Training

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

2-hour in-person instruction of home care issues for caregivers of patients with cancer.

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 caregiving.

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

Primary outcomes

  1. Self-efficacy in symptom management

    Time frame: One month

Secondary outcomes

  1. Psychological well-being

    Time frame: One month

  2. Management of psychological distress

    Time frame: One month

  3. Quality of Life

    Time frame: One month

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Enhanced Self-Efficacy Training For Informal Cancer Caregivers

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2009
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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