Psychosocial Effects of Cancer and Its Treatment Clinical Trial
Official title:
A Randomized Trial of a Family Caregiver Palliative Care Intervention
| Verified date | January 2020 |
| Source | City of Hope Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | May 23, 2019 |
| Est. primary completion date | May 23, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up - Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease - Primary family caregivers of cancer patients with > 6 months prognosis - Living within a 50 mile radius of the City of Hope |
| Country | Name | City | State |
|---|---|---|---|
| United States | City of Hope Medical Center | Duarte | California |
| Lead Sponsor | Collaborator |
|---|---|
| City of Hope Medical Center | American Cancer Society (ACS) National Office, National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden | Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA). | Up to 6 months | |
| Primary | Effects of FCPCI on caregiving skills preparedness | ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA. | Up to 6 months | |
| Primary | Effects of FCPCI on Quality Of Life (QOL) | ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores. | Up to 6 months | |
| Primary | Effects of FCPCI on psychological distress | ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores. | Up to 6 months | |
| Secondary | Caregiver's self-care behavior | Qualitative analyses will be conducted on the narrative responses to the Self-Care Behaviors instrument. Self-care behaviors will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of coded themes with examples will be created. | Up to 6 months | |
| Secondary | Caregivers' resource use | The qualitative analysis will be conducted on the narrative responses to the Resource Use instrument. Resources will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of categories and codes will be created. | Up to 6 months | |
| Secondary | Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics | In four separate hierarchical multiple linear regression analyses, the 3 month outcome measure (caregiver burden, skills preparedness, psychological distress, and total QOL) will be regressed first on baseline measures for the relevant outcomes, followed by demographic and caregiver health status variables, and then by patient characteristics and severity of illness, using dummy-coding as appropriate. | 3 months | |
| Secondary | Family caregivers' satisfaction with the FCPCI | A descriptive analysis of the brief satisfaction survey item results for subjects in the experimental group will be conducted, summarizing number and percent for normal data or means and standard deviations for continuous data. | 6 months | |
| Secondary | Caregiver out-of-pocket costs | A descriptive analysis of family caregivers' costs will be conducted. | Up to 6 months |
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