NCT01846520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

May 1, 2013

Last Update Submit

January 21, 2020

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

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Caregiver's self-care behavior

    Up to 6 months

  • Caregivers' resource use

    Up to 6 months

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

    3 months

  • Family caregivers' satisfaction with the FCPCI

    6 months

  • Caregiver out-of-pocket costs

    Up to 6 months

Study Arms (2)

Arm I (FCPCI)

EXPERIMENTAL

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 interventionBehavioral: telephone-based interventionProcedure: quality-of-life assessmentOther: questionnaire administration

Arm II (usual care)

NO INTERVENTION

Participants receive usual care.

Interventions

educational interventionOTHER

Receive FCPCI home education sessions

Also known as: intervention, educational
Arm I (FCPCI)
telephone-based interventionBEHAVIORAL

Receive FCPCI telephone support sessions and 24 hour telephone support

Arm I (FCPCI)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (FCPCI)
questionnaire administrationOTHER

Ancillary studies

Arm I (FCPCI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsColonic NeoplasmsStomach NeoplasmsCarcinoma, Ovarian EpithelialPancreatic NeoplasmsRectal NeoplasmsCarcinoma, Renal CellUrethral NeoplasmsUreteral NeoplasmsLung Neoplasms

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesRectal DiseasesAdenocarcinomaKidney NeoplasmsKidney DiseasesUrethral DiseasesUreteral DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Betty Ferrell

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 3, 2013

Study Start

October 1, 2013

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

US(1)