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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by City of Hope Medical Center
Sponsor:
Collaborators:
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: June 12, 2014
Last verified: June 2014
  Purpose

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, and urologic 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, no Evidence of Disease
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
Other: educational intervention
Behavioral: telephone-based intervention
Procedure: quality-of-life assessment
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A descriptive analysis of family caregivers' costs will be conducted.


Estimated Enrollment: 200
Study Start Date: October 2013
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, and urologic 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, and urologic 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 rational 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, or urinary cancers who are entering the City of Hope for treatment or follow-up
  • Primary family caregivers of cancer patients whoa re 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
American Cancer Society (ACS) National Office
Investigators
Principal Investigator: Betty Ferrell City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01846520     History of Changes
Other Study ID Numbers: 08176, NCI-2013-00839
Study First Received: May 1, 2013
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Adnexal Diseases
Colonic Diseases
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Genital Diseases, Female
Gonadal Disorders
Intestinal Diseases
Kidney Diseases
Ovarian Diseases
Pancreatic Diseases
Rectal Diseases
Stomach Diseases
Ureteral Diseases
Urethral Diseases
Urinary Bladder Diseases
Urologic Diseases
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Colonic Neoplasms
Germinoma
Kidney Neoplasms
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014