- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213078
Family Caregivers in Underserved Populations Providing Complex Cancer Care
Study Overview
Status
Conditions
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Malignant Female Reproductive System Neoplasm
- 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 IIIC Lung Cancer AJCC v8
- Stage 0 Lung Cancer AJCC v8
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Ancillary studies
Other Names:
Ancillary studies
Receive teaching intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Family caregiver distress scale
Time Frame: 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.
|
up to 7 weeks
|
Change in Quality of life (QOL) scale
Time Frame: 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.
|
Up to 7 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Betty Ferrell, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Lung Neoplasms
- Genital Neoplasms, Female
Other Study ID Numbers
- 20137 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2020-11090 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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