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

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

A Randomized Trial of a Family Caregiver Palliative Care Intervention

NCT01846520•City of Hope Medical Center

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

May 23, 2019

Completion Date

May 23, 2019

Last Updated

January 23, 2020

Enrollment

200

ESTIMATED participants

Conditions

Healthy SubjectLocalized Transitional Cell Cancer of the Renal Pelvis and UreterMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterPsychosocial Effects of Cancer and Its TreatmentRecurrent Bladder CancerRecurrent Cervical CancerRecurrent Colon CancerRecurrent Gastric CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Uterine SarcomaRegional Transitional Cell Cancer of the Renal Pelvis and UreterStage II Bladder CancerStage II Renal Cell CancerStage II Urethral CancerStage IIA Cervical CancerStage IIA Colon CancerStage IIA Gastric CancerStage IIA Ovarian Epithelial CancerStage IIA Ovarian Germ Cell TumorStage IIA Pancreatic CancerStage IIA Rectal CancerStage IIA Uterine SarcomaStage IIB Cervical CancerStage IIB Colon CancerStage IIB Gastric CancerStage IIB Ovarian Epithelial CancerStage IIB Ovarian Germ Cell TumorStage IIB Pancreatic CancerStage IIB Rectal CancerStage IIB Uterine SarcomaStage IIC Colon CancerStage IIC Ovarian Epithelial CancerStage IIC Ovarian Germ Cell TumorStage IIC Rectal CancerStage III Bladder CancerStage III Pancreatic CancerStage III Renal Cell CancerStage III Urethral CancerStage IIIA Cervical CancerStage IIIA Colon CancerStage IIIA Gastric CancerStage IIIA Ovarian Epithelial CancerStage IIIA Ovarian Germ Cell TumorStage IIIA Rectal CancerStage IIIA Uterine SarcomaStage IIIB Cervical CancerStage IIIB Colon CancerStage IIIB Gastric CancerStage IIIB Ovarian Epithelial CancerStage IIIB Ovarian Germ Cell TumorStage IIIB Rectal CancerStage IIIB Uterine SarcomaStage IIIC Colon CancerStage IIIC Gastric CancerStage IIIC Ovarian Epithelial CancerStage IIIC Ovarian Germ Cell TumorStage IIIC Rectal CancerStage IIIC Uterine SarcomaStage IV Bladder CancerStage IV Gastric CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Renal Cell CancerStage IV Urethral CancerStage IVA Cervical CancerStage IVA Colon CancerStage IVA Rectal CancerStage IVA Uterine SarcomaStage IVB Cervical CancerStage IVB Colon CancerStage IVB Rectal CancerStage IVB Uterine SarcomaUreter CancerStage IIA Lung CarcinomaStage IIB Lung CarcinomaStage IIIA Lung CarcinomaStage IIIB Lung Carcinoma

Interventions

educational intervention

OTHER

telephone-based intervention

BEHAVIORAL

quality-of-life assessment

PROCEDURE

questionnaire administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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