Healthy SubjectNCT02729883
Take the Fight in Supporting and Empowering Patients With Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Supportive Care in people with Healthy Subject and Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Malignant Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Supportive Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Healthy Subject, Malignant Neoplasm
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Supportive Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete interviews
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive patient navigation via the Take the Fight strategists
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (Take the Fight) | Experimental | 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 18 weeks
Change in strategists self-reported outcomes using Caregiver Quality of Life Index-Cancer (CQOLC, McMillian, 1996) scale
Measured: Baseline to up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Funding Issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stefan Grant, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729883
- Sponsor's protocol ID
- IRB00037093
- Other IDs
- NCI-2016-00384, CCCWFU 99216, P30CA012197
- Status last verified
- Jun 2018
- First submitted
- 28 Mar 2016
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 'Take the Fight' as Community-Based Participatory Research
- ClinicalTrials.gov ID
- NCT02729883
- Acronym / sponsor ID
- IRB00037093
- Conditions
- Healthy Subject, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Issue
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (Take the Fight) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Supportive CarePatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (Take the Fight) |
| Questionnaire AdministrationComplete interviews | Other | Supportive care (Take the Fight) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive patient navigation via the Take the Fight strategists | Procedure or surgery | Supportive care (Take the Fight) |
Primary outcome
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
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.
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
Results and safety
The study was stopped early (reason given: Funding Issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Related trials for Healthy Subject
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Grant principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Supportive Care in people with Healthy Subject and Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding Issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline to up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.