Take the Fight in Supporting and Empowering Patients With Cancer

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02729883
• Other study ID #: IRB00037093
• Secondary ID: NCI-2016-00384CC
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete interviews

Procedure:
• Supportive Care
Receive patient navigation via the Take the Fight strategists

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale		Baseline to up to 10 weeks