- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729883
Take the Fight in Supporting and Empowering Patients With Cancer
A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Delineate the benefits of and limitations to having Take the Fight strategists, performing as lay-navigators, as perceived by both the patients and the students.
SECONDARY OBJECTIVES:
I. Investigate changes in self-reported outcomes for patients and the Take the Fight strategists.
OUTLINE:
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks. Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
After completion of study, patients and strategists are followed up for 8-10 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Comprehensive Cancer Center of Wake Forest University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PATIENTS ELIGIBILITY CRITERIA
- Have histologically confirmed cancer
- Karnofsky performance scale (KPS) score of >= 60
- The ability to understand and be willing to sign an informed consent document
- Willing to undergo a form of cancer therapy and subsequent follow-up care
- STRATEGISTS INCLUSION CRITERIA
- Age >= 18 years
- Wake Forest University student
- Have volunteered as a student strategist at Comprehensive Cancer Center of Wake Forest University (CCCWFU); all strategists are required to have gone through Take the Fight (TTF) training prior to their volunteer work
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 (Take the Fight)
Patients receive patient navigation via strategists from the Take the Fight for 8 weeks.
Patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance.
Strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy.
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Ancillary studies
Other Names:
Complete interviews
Receive patient navigation via the Take the Fight strategists
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patients self-reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Cancer 30 (QLQ-C30) questionnaire
Time Frame: Baseline to up to 18 weeks
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Descriptive statistics will be measured, including frequencies, percentages, means and standard deviations of patient self-report measures will be calculated.
Ninety-five percent confidence intervals will also be calculated for the outcomes measures at each time point.
|
Baseline to up to 18 weeks
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Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
Time Frame: Baseline to up to 10 weeks
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Baseline to up to 10 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stefan Grant, Wake Forest University Health Sciences
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 (Estimate)
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
Other Study ID Numbers
- IRB00037093
- P30CA012197 (U.S. NIH Grant/Contract)
- NCI-2016-00384 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CCCWFU 99216 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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