Clinical trial NCT02729883: Take the Fight in Supporting and Empowering Patients With Cancer
Official title: A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Subject
Malignant Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-06
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in patients self-reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Cancer 30 (QLQ-C30) questionnaire
timeFrame: Baseline to up to 18 weeks
measure: Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
timeFrame: Baseline to up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stefan Grant
role: PRINCIPAL_INVESTIGATOR
References: