NCT05213078

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

December 10, 2020

Last Update Submit

January 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 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.

    Up to 7 weeks

Study Arms (1)

Supportive Care (teaching intervention, questionnaire)

EXPERIMENTAL

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

Other: Educational InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Receive teaching intervention

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Supportive Care (teaching intervention, questionnaire)

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (teaching intervention, questionnaire)

Ancillary studies

Supportive Care (teaching intervention, questionnaire)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Inability to read and understand English

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

Lung Neoplasms

Interventions

Early Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Betty Ferrell

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2020

First Posted

January 28, 2022

Study Start

July 15, 2020

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations