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BRIEF TITLE: A Randomized Trial of a Family Caregiver Palliative Care Intervention

A Randomized Trial of a Family Caregiver Palliative Care Intervention


  • Org Study ID: 08176
  • Secondary ID: NCI-2013-00839
  • NCT ID: NCT01846520
  • NCT Alias:
  • Sponsor: City of Hope Medical Center - Other
  • Source: City of Hope Medical Center

Brief Summary

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.

Detailed Description


PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention
(FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and
lung cancers in the experimental group on caregiver burden and caregiving skills preparedness
as compared to family caregivers in the control group.

II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal,
gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and
psychological distress as compared to family caregivers in the control group.

SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the
experimental and control groups.

II. Describe family caregivers' resource use, comparing the experimental and control groups.

III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to
sociodemographic, health status, and patient characteristics.

IV. Describe family caregivers' satisfaction with the FCPCI.

V. Describe caregiver out-of-pocket costs and the cost of the intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive FCPCI with an advanced practice nurse (APN), comprising 4 home
education sessions once weekly followed by 4 telephone support sessions for 30 minutes once
monthly and 24 hour telephone support available for 6 months.

ARM II: Participants receive usual care

Overal Status Start Date Phase Study Type
Recruiting Start Date: October 2013 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden

Primary Outcome 1 - Time Frame: Up to 6 months

Primary Outcome 2 - Measure: Effects of FCPCI on caregiving skills preparedness

Primary Outcome 2 - Time Frame: Up to 6 months

Primary Outcome 3 - Measure: Effects of FCPCI on Quality Of Life (QOL)

Primary Outcome 3 - Time Frame: Up to 6 months

Primary Outcome 4 - Measure: Effects of FCPCI on psychological distress

Primary Outcome 4 - Time Frame: Up to 6 months

Condition:

  • Healthy Subject
  • Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Psychosocial Effects of Cancer and Its Treatment
  • Recurrent Bladder Cancer
  • Recurrent Cervical Cancer
  • Recurrent Colon Cancer
  • Recurrent Gastric Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pancreatic Cancer
  • Recurrent Rectal Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Recurrent Uterine Sarcoma
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage II Bladder Cancer
  • Stage II Renal Cell Cancer
  • Stage II Urethral Cancer
  • Stage IIA Cervical Cancer
  • Stage IIA Colon Cancer
  • Stage IIA Gastric Cancer
  • Stage IIA Ovarian Epithelial Cancer
  • Stage IIA Ovarian Germ Cell Tumor
  • Stage IIA Pancreatic Cancer
  • Stage IIA Rectal Cancer
  • Stage IIA Uterine Sarcoma
  • Stage IIB Cervical Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Gastric Cancer
  • Stage IIB Ovarian Epithelial Cancer
  • Stage IIB Ovarian Germ Cell Tumor
  • Stage IIB Pancreatic Cancer
  • Stage IIB Rectal Cancer
  • Stage IIB Uterine Sarcoma
  • Stage IIC Colon Cancer
  • Stage IIC Ovarian Epithelial Cancer
  • Stage IIC Ovarian Germ Cell Tumor
  • Stage IIC Rectal Cancer
  • Stage III Bladder Cancer
  • Stage III Pancreatic Cancer
  • Stage III Renal Cell Cancer
  • Stage III Urethral Cancer
  • Stage IIIA Cervical Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Rectal Cancer
  • Stage IIIA Uterine Sarcoma
  • Stage IIIB Cervical Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Rectal Cancer
  • Stage IIIB Uterine Sarcoma
  • Stage IIIC Colon Cancer
  • Stage IIIC Gastric Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Rectal Cancer
  • Stage IIIC Uterine Sarcoma
  • Stage IV Bladder Cancer
  • Stage IV Gastric Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Pancreatic Cancer
  • Stage IV Renal Cell Cancer
  • Stage IV Urethral Cancer
  • Stage IVA Cervical Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVA Uterine Sarcoma
  • Stage IVB Cervical Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Stage IVB Uterine Sarcoma
  • Ureter Cancer
  • Stage IIA Lung Carcinoma
  • Stage IIB Lung Carcinoma
  • Stage IIIA Lung Carcinoma
  • Stage IIIB Lung Carcinoma

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Official Information

Name: Betty Ferrell

Role: Principal Investigator

Affiliation: City of Hope Medical Center

Location

Facility Status Contact
City of Hope Medical Center
Duarte, California 91010
United States
Recruiting Betty Ferrell
800-826-4673
bferrell@coh.org