Head and Neck CancerNCT03207594
Improving Evidence-Based Care for Cancer Patients
An observational study of Head and Neck Cancer and Prostate Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer, Prostate Cancer, Breast Cancer
- What is being tested?
- Survey, Saliva sample and Smoking Status questions
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 1 Mar 2020
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who have been diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancers that are 21 years of age or older. Patients must have been referred to MUSC radiation oncology for treatment with curative radiation therapy
Who may be able to join
- Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer
- 21 years of age or older at time of study registration
- Must have been referred to MUSC radiation oncology for treatment with curative radiation therapy
- Must report current smoking defined as self-reporting smoking within the past 30 days using a structured intake questionnaire.
Who cannot join
- Patients with primary central nervous system malignancies will be excluded.
- Patients that have other cancer disease types will be excluded due to either significant differences in standard radiation therapy approaches or rarity of disease required radiation.
- Patients who are currently participating in the Medical University of South Carolina Hollings Cancer Center smoking cessation program
- Patients who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care.
- Conditions
- Head and Neck Cancer, Prostate Cancer, Breast Cancer, Lung Cancer, Gynecologic Cancer, Gastrointestinal Cancer
- Being tested
- Survey, Saliva sample, Smoking Status questions
- Medical subject headings
- Head and Neck Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.
Saliva sampleOther
Subjects will have saliva collected by a member of the study team using a cotton swab.
Smoking Status questionsOther
Subjects will be asked to complete an assessment asking questions about his/her current smoking status
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Current smokers with cancer who are planning to get radiation therapy at MUSC. Receives: Other: Survey; Other: Saliva sample; Other: Smoking Status questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with biochemically confirmed smoking cessation
Biochemical confirmation will be determined by saliva samples
Measured: 4 weeks after enrollment
Number of patient who self-report smoking cessation
Self-reported smoking cessation will be documented via smoking assessment questionnaire
Measured: 4 weeks after enrollment
Secondary outcomes (3)
Average weekly smoke exposure
reported cigarettes per day multiplied by the number of days smoked during radiation therapy (RT), summed over a period of time and normalized to yield an average weekly smoke exposure during RT.
Measured: up to 62 weeks
Number of patients who participate in smoking cessation
Completing one in-person visit where an individualized smoking cessation treatment plan is developed and implemented.
Measured: up to 12 months after completion of RT.
Compliance with smoking cessation
Two binary measure of compliance:
- - completing at least three in person visits within 6 weeks of starting an individualized cessation treatment plan
- - completing at least one in-person visit and at least two phone-based communications
Measured: up to 12 weeks after completion of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Sep 2016
- Primary completion1 May 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Graham Warren, MD, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207594
- Sponsor's protocol ID
- 102472
- Status last verified
- Jan 2025
- First submitted
- 22 Mar 2017
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Evidence-Based Care for Cancer Patients
- ClinicalTrials.gov ID
- NCT03207594
- Acronym / sponsor ID
- 102472
- Conditions
- Head and Neck Cancer, Prostate Cancer, Breast Cancer, Lung Cancer, Gynecologic Cancer, Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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.
The purpose of this study is to improve cancer care and the delivery of cancer care. Researchers are interested in studying patient reported information and examining how different factors may impact cancer care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Survey, Other: Saliva sample, Other: Smoking Status questionsCurrent smokers with cancer who are planning to get radiation therapy at MUSC. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who have been diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancers that are 21 years of age or older. Patients must have been referred to MUSC radiation oncology for treatment with curative radiation therapy
Key inclusion criteria (4 listed)
- Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer
- 21 years of age or older at time of study registration
- Must have been referred to MUSC radiation oncology for treatment with curative radiation therapy
- Must report current smoking defined as self-reporting smoking within the past 30 days using a structured intake questionnaire.
Key exclusion criteria (4 listed)
- Patients with primary central nervous system malignancies will be excluded.
- Patients that have other cancer disease types will be excluded due to either significant differences in standard radiation therapy approaches or rarity of disease required radiation.
- Patients who are currently participating in the Medical University of South Carolina Hollings Cancer Center smoking cessation program
- Patients who are unable to provide informed consent
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 |
|---|---|---|
| SurveySubjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life. | Other | Arm 1 |
| Saliva sampleSubjects will have saliva collected by a member of the study team using a cotton swab. | Other | Arm 1 |
| Smoking Status questionsSubjects will be asked to complete an assessment asking questions about his/her current smoking status | Other | Arm 1 |
Primary outcome
Number of patients with biochemically confirmed smoking cessation
Time frame: 4 weeks after enrollment
Biochemical confirmation will be determined by saliva samples
Number of patient who self-report smoking cessation
Time frame: 4 weeks after enrollment
Self-reported smoking cessation will be documented via smoking assessment questionnaire
3 secondary outcomes
Average weekly smoke exposure
Time frame: up to 62 weeks
Number of patients who participate in smoking cessation
Time frame: up to 12 months after completion of RT.
Compliance with smoking cessation
Time frame: up to 12 weeks after completion of RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Not yet recruitingPhase 3
Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
Esophageal Cancer
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
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.
Graham Warren, MD, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Prostate Cancer, run by Medical University of South Carolina 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with biochemically confirmed smoking cessation (time frame: 4 weeks after enrollment). 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 31 Jan 2025.