Clincosm LogoSign in Get a demo

Family Caregivers in Underserved Populations Providing Complex Cancer Care

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05213078
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial develops and tests a model of family caregiver education focused on the role of underserved family caregivers as providers of complex care in the home. Cancer patients have symptoms from their cancer or treatment and are then supported by family caregivers at home with tasks requiring technical skill. Family caregivers are often asked to provide complex care whether it involves decisions about managing symptoms or providing technical care for ports/pumps, tubes, or devices. Family caregivers often are not given enough information on how to provide care for patients at home needing complex care. The results from this study may help researchers refine and improve the intervention for caregivers through future research for caregivers on a much larger scale.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. Develop methods of assessing and supporting family caregiving skills in providing complex care.

  2. Develop family caregiver (FCG) teaching materials and methods of instruction to enhance skills preparedness.

  3. Pilot test the intervention in a cohort of underserved FCGs.

OUTLINE:

Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Family Caregivers in Underserved Populations Providing Complex Cancer Care
Actual Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (teaching intervention, questionnaire)

Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.

Other: Educational Intervention
Receive teaching intervention
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in Family caregiver distress scale [up to 7 weeks]

      Descriptive statistics will be used to summarize the distress scale. Analysis of variance (ANOVA) will be used to compare scores at the three points of baseline, 3 weeks, and 7 weeks.

    2. Change in Quality of life (QOL) scale [Up to 7 weeks]

      Descriptive statistics will be used to summarize the Caregiver QOL scale. ANOVA will be used to compare scores at the three points of baseline, 3 weeks, and 7 weeks.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • PATIENT: Diagnosis of any stage lung or gynecologic (gyn) cancer

    • PATIENT: Read and understand English

    • PATIENT: Requires either complex physical care or complex decision making regarding symptoms

    • PATIENT: Age 18 years or older

    • FCG: Designated by the patient as their caregiver

    • FCG: Read and understand English

    • FCG: Age 18 years or older

    • FCG: Providing complex care and/or complex decision-making

    Exclusion Criteria:
    • Inability to read and understand English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Betty Ferrell, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT05213078
    Other Study ID Numbers:
    • 20137
    • NCI-2020-11090
    • 20137
    • P30CA033572
    First Posted:
    Jan 28, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Genital Neoplasms, Female

    Study Results

    No Results Posted as of Jun 8, 2022