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OpenTrials
Completed

NCT Number: NCT05213078

Family Caregivers in Underserved Populations Providing Complex Cancer Care

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive teaching intervention

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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