Take the Fight in Supporting and Empowering Patients With Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies Take the Fight in supporting and empowering patients with cancer through their treatment process. Patients with cancer are faced with many obstacles created by the current state of the healthcare system. The purpose of Take the Fight is to train college students, also called patients' navigators or strategists, to assist and support patients to navigate into the healthcare system and receive the care they need. The strategists are matched with patients and attend/coordinate most patients' medical appointments. The strategists also advance communications between the patient and the medical staff to facilitate both the exchange of medical information as well as increase the patient's compliance with treatment. Take the Fight may improve the health and quality of life outcomes of cancer patients during critical treatment periods by increasing treatment compliance, eliminating barriers to better care, and increasing clinical trial participation.

Detailed Description
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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.

Official Title
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A Pilot Study of 'Take the Fight' as Community-Based Participatory Research

Conditions
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Healthy Subject, Malignant Neoplasm

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Take the Fight)<br>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. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete interviews<br>Procedure: Supportive Care<br>* Receive patient navigation via the Take the Fight strategists<br>* Other names: Therapy, Supportive;|

What is the study measuring?
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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 | 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 | 
| Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale |  | Baseline to up to 10 weeks |