- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00938769
Enhanced Self-Efficacy Training
Enhanced Self-Efficacy Training For Informal Cancer Caregivers
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27705
- Duke University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
|
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. |
|
Övrig: 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.
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Self-efficacy in symptom management
Tidsram: One month
|
One month
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Psychological well-being
Tidsram: One month
|
One month
|
|
Management of psychological distress
Tidsram: One month
|
One month
|
|
Quality of Life
Tidsram: One month
|
One month
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: James A Tulsky, MD, Duke University School of Nursing
- Huvudutredare: Cristina Hendrix, PhD, Duke University School of Nursing
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Pro00009040
- 1P01NR010948-01 (U.S.S. NIH-anslag/kontrakt)
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