Improving Evidence-Based Care for Cancer Patients

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Head and Neck Cancer; Gynecologic Cancer; Lung Cancer; Prostate Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Other: Survey; Other: Saliva sample; Other: Smoking Status questions

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; Current smokers with cancer who are planning to get radiation therapy at MUSC.	Other: Survey; Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.; Other: Saliva sample; Subjects will have saliva collected by a member of the study team using a cotton swab.; Other: Smoking Status questions; Subjects will be asked to complete an assessment asking questions about his/her current smoking status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with biochemically confirmed smoking cessation	Biochemical confirmation will be determined by saliva samples	4 weeks after enrollment
Number of patient who self-report smoking cessation	Self-reported smoking cessation will be documented via smoking assessment questionnaire	4 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Graham Warren, MD, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 102472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO