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Family Caregivers in Underserved Populations Providing Complex Cancer Care

Primary Purpose

Malignant Female Reproductive System Neoplasm, Stage 0 Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Female Reproductive System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (teaching intervention, questionnaire)

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Family caregiver distress scale
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.
Change in Quality of life (QOL) scale
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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2020
Last Updated
February 15, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05213078
Brief Title
Family Caregivers in Underserved Populations Providing Complex Cancer Care
Official Title
Family Caregivers in Underserved Populations Providing Complex Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. Develop methods of assessing and supporting family caregiving skills in providing complex care. II. Develop family caregiver (FCG) teaching materials and methods of instruction to enhance skills preparedness. III. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm, Stage 0 Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (teaching intervention, questionnaire)
Arm Type
Experimental
Arm Description
Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive teaching intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Family caregiver distress scale
Description
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.
Time Frame
up to 7 weeks
Title
Change in Quality of life (QOL) scale
Description
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.
Time Frame
Up to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Ferrell
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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Family Caregivers in Underserved Populations Providing Complex Cancer Care

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