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OpenTrials
Completed

NCT Number: NCT03207594

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.

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Key information

Conditions

Head and Neck Cancer Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gynecologic Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

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

Saliva Sample

Other

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

Smoking Status questions

Other

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

Primary outcomes

  1. Number of patients with biochemically confirmed smoking cessation

    Time frame: 4 weeks after enrollment

    Biochemical confirmation will be determined by saliva samples

  2. 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

Secondary outcomes

  1. Average weekly smoke exposure

    Time frame: up to 62 weeks

    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.

  2. Number of patients who participate in smoking cessation

    Time frame: up to 12 months after completion of RT.

    Completing one in-person visit where an individualized smoking cessation treatment plan is developed and implemented.

  3. Compliance with smoking cessation

    Time frame: up to 12 weeks after completion of RT

    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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 5, 2017
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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