Improving Evidence-Based Care for Cancer Patients

NCT03207594 | Completed DMC

• 1 other identifier: 102472
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Prostate Cancer; Breast Cancer; Lung Cancer; Gynecologic Cancer; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Average weekly smoke exposure

  up to 62 weeks

• Number of patients who participate in smoking cessation

  up to 12 months after completion of RT.

• Compliance with smoking cessation

  up to 12 weeks after completion of RT

Study Arms (1)

Arm 1

Current smokers with cancer who are planning to get radiation therapy at MUSC.

Other: Survey; Other: Saliva sample; Other: Smoking Status questions

Interventions

Survey OTHER

Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.

Arm 1

Saliva sample OTHER

Subjects will have saliva collected by a member of the study team using a cotton swab.

Arm 1

Smoking Status questions OTHER

Subjects will be asked to complete an assessment asking questions about his/her current smoking status

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosed with head/neck, lung, breast, prostate, gastrointestinal or gynecologic cancer
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Graham Warren, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: July 5, 2017
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)