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Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by City of Hope Medical Center
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society (ACS) National Office
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01846520
First received: May 1, 2013
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
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 Other: educational intervention Behavioral: telephone-based intervention Procedure: quality-of-life assessment Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of a Family Caregiver Palliative Care Intervention

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden [ Time Frame: Up to 6 months ]
    Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).

  • Effects of FCPCI on caregiving skills preparedness [ Time Frame: Up to 6 months ]
    ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.

  • Effects of FCPCI on Quality Of Life (QOL) [ Time Frame: Up to 6 months ]
    ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.

  • Effects of FCPCI on psychological distress [ Time Frame: Up to 6 months ]
    ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.


Secondary Outcome Measures:
  • Caregiver's self-care behavior [ Time Frame: Up to 6 months ]
    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.

  • Caregivers' resource use [ Time Frame: Up to 6 months ]
    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.

  • Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics [ Time Frame: 3 months ]
    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.

  • Family caregivers' satisfaction with the FCPCI [ Time Frame: 6 months ]
    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.

  • Caregiver out-of-pocket costs [ Time Frame: Up to 6 months ]
    A descriptive analysis of family caregivers' costs will be conducted.


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (FCPCI)
Participants receive FCPCI with an 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.
Other: educational intervention
Receive FCPCI home education sessions
Other Name: intervention, educational
Behavioral: telephone-based intervention
Receive FCPCI telephone support sessions and 24 hour telephone support
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
No Intervention: Arm II (usual care)
Participants receive usual care.

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846520

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Betty Ferrell    800-826-4673    bferrell@coh.org   
Principal Investigator: Betty Ferrell         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
American Cancer Society (ACS) National Office
Investigators
Principal Investigator: Betty Ferrell City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01846520     History of Changes
Other Study ID Numbers: 08176
NCI-2013-00839 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: May 1, 2013
Last Updated: February 8, 2017

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Pancreatic Neoplasms
Sarcoma
Stomach Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Carcinoma, Renal Cell
Lung Neoplasms
Germinoma
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 21, 2017