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Trial record 7 of 36 for:    complementary and alternative medicine AND Survey

Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01823549
Recruitment Status : Active, not recruiting
First Posted : April 4, 2013
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

March 28, 2013
April 4, 2013
May 24, 2018
October 2011
September 2014   (Final data collection date for primary outcome measure)
  • Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation. [ Time Frame: Up to 1 year ]
    Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation therapy at The James Cancer Hospital and Solove Research Institute. Nutrient supplements and alternative medication use is the primary focus of the assessment.
  • Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment. [ Time Frame: Up to 1 year ]
  • Assess quality of life using validated instruments during radiation therapy and determine if there is a correlation between CAM use and quality of life. [ Time Frame: Up to 1 year ]
  • Assess radiation therapy toxicity using standardized criteria from the Oncology Nursing Society and determine if there is a correlation between CAM use and measures of toxicity. [ Time Frame: Up to 1 year ]
  • To determine predictive factors for CAM and nutritional supplement use, such as age, race, income, education, marital status, or tobacco/alcohol use. [ Time Frame: Up to 1 year ]
  • Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation. [ Time Frame: Up to 1 year ]
    Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation therapy at The James Cancer Hospital and Solove Research Institute. Nutrient supplements and alternative medication use is the primary focus of the assessment.
  • Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment. [ Time Frame: Up to 1 year ]
  • Assess quality of life using validated instruments during radiation therapy and determine if there is a correlation between CAM use and quality of life. [ Time Frame: Up to 1 year ]
  • Assess radiation therapy toxicity using standardized criteria from the Oncology Nursing Society and determine if there is a correlation between CAM use and quality of life. [ Time Frame: Up to 1 year ]
  • To determine predictive factors for CAM and nutritional supplement use, such as age, race, income, education, marital status, or tobacco/alcohol use. Study Plan: [ Time Frame: Up to 1 year ]
Complete list of historical versions of study NCT01823549 on ClinicalTrials.gov Archive Site
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Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients
Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
This study was a survey to determine the frequency of Complementary and Alternative Medicine (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting radiation therapy. The survey was repeated at three time points to assess changes in CAM use over time.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Men with clinically localized prostate cancer that have chosen external beam irradiation or brachytherapy or a combination for their treatment and women with localized breast cancer who are scheduled to begin external beam radiation therapy as a component of their primary or adjuvant therapy.
  • Prostate Cancer
  • Breast Cancer
Other: questionnaire administration
Ancillary studies
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Same as current
February 2019
September 2014   (Final data collection date for primary outcome measure)

Inclusion/Exclusions

  • Men that have histologically proven carcinoma of the prostate and have chosen some form of radiation therapy as their primary therapy for prostate cancer.
  • Women who are undergoing external beam radiation therapy to the breast as primary or adjuvant therapy are eligible.
  • All participants must be able to read and write.
  • Subjects with dementia and mental retardation that complicates completing the questionnaires will not be enrolled.
  • Subjects with known metastatic disease will be excluded.
  • There are no age restrictions for this study.
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01823549
OSU-0240
Yes
Not Provided
Not Provided
Steven Clinton, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Steven Clinton, MD Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
May 2018