Improving Evidence-Based Care for Cancer Patients

Breast Cancer Clinical Trial

Official title:

Improving Evidence-Based Care for Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03207594
• Other study ID #: 102472
• Status: Active, not recruiting
• Start date: September 1, 2016
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gynecologic Cancer
• Head and Neck Cancer
• Lung Cancer
• Prostate Cancer

Intervention

Other:
• Survey
Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.
• Saliva sample
Subjects will have saliva collected by a member of the study team using a cotton swab.
• Smoking Status questions
Subjects will be asked to complete an assessment asking questions about his/her current smoking status

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with biochemically confirmed smoking cessation	Biochemical confirmation will be determined by saliva samples	4 weeks after enrollment
Primary	Number of patient who self-report smoking cessation	Self-reported smoking cessation will be documented via smoking assessment questionnaire	4 weeks after enrollment
Secondary	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.	up to 62 weeks
Secondary	Number of patients who participate in smoking cessation	Completing one in-person visit where an individualized smoking cessation treatment plan is developed and implemented.	up to 12 months after completion of RT.
Secondary	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	up to 12 weeks after completion of RT