Malignant Female Reproductive System NeoplasmNCT05213078
Family Caregivers in Underserved Populations Providing Complex Cancer Care
A study testing Educational Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm and Stage 0 Lung Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Stage 0 Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8
- What is being tested?
- Educational Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 9 Mar 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- 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
- Being tested
- Educational Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive teaching intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Jul 2020
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Betty Ferrell, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213078
- Sponsor's protocol ID
- 20137
- Other IDs
- NCI-2020-11090, 20137, P30CA033572
- Status last verified
- Jan 2024
- First submitted
- 10 Dec 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No