Pain in Cancer Survivors

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Medical Center
Vanderbilt University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581724
First received: December 21, 2007
Last updated: January 25, 2012
Last verified: January 2012

December 21, 2007
January 25, 2012
May 2007
January 2012   (final data collection date for primary outcome measure)
Descriptive statistics will be generated to describe the prevalence of pain and its psychosocial correlates. [ Time Frame: 1 to 10 years post-treatment completion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581724 on ClinicalTrials.gov Archive Site
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Pain in Cancer Survivors
Pain in Cancer Survivors

The purpose of this study is to find out about the pain and quality of life of individuals who are adult cancer survivors. By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. In addition, learning about pain will help us to develop new services for adult cancer survivors.

The main objective of the proposed study is to identify the prevalence of persistent pain in a sample of adult cancer survivors. Currently, there is a lack of comprehensive information about pain in the cancer survivor population. Although prior studies have assessed pain syndromes in breast and lung cancer survivors (e.g., post-mastectomy and post-thoracotomy pain), there is a lack of information about the prevalence and characteristics of post-treatment pain in other subpopulations of survivors. To address this knowledge gap, a random sample of cancer survivors who are from 1 to 10 years post-treatment completion and who were treated at Memorial Sloan-Kettering Cancer Center will complete a telephone-administered pain interview and assessment battery focusing on pain, quality of life, and psychological distress. Our initial recruitment and evaluation will begin in 50 breast cancer survivors and then will expand 50 survivors in each of the other services Colorectal, Genitourinary, Head and Neck, and Thoracic in allotments of 50 participants each. We estimate that the completion time for the interview and assessment battery will range from 45 to 60 minutes. This telephone-based survey will identify vulnerable subgroups of patients with persistent pain and provide a knowledge base for future research on the prevalence and risk factors for post-treatment pain in the cancer survivor population.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Adult cancer survivors that were treated for cancer at Memorial Sloan-Kettering Cancer Center (MSKCC) and it has been at least a year since you completed treatment.

  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Head and Neck Cancer
  • Lung Cancer
Behavioral: Telephone interview or self report survey.
We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.
1

First 50 breast cancer survivors and then after demonstrating feasibility of the study design in the first 50 participants, recruitment will be opened to the other services Colorectal, Genitourinary, Head and Neck, and Thoracic.

Participants will be recruited in allotments of 50 patients from each service.

Intervention: Behavioral: Telephone interview or self report survey.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cancer treatment at MSKCC
  • Are from 1 to 10 years post-treatment completion at the time of study recruitment
  • No evidence of disease (NED) at the time of assessment;
  • Over 18 years of age
  • Can be reached by telephone
  • Able to provide informed consent
  • Able to speak and read English
  • Cancer survivors who received adjuvant therapies outside MSKCC will be asked to self-report the type and duration of cancer treatments received.

Exclusion Criteria:

  • Undergoing active cancer treatment (ongoing tamoxifen use, hormone replacement therapy or use of biologics are permitted)
  • Evidence of encephalopathy, psychotic illness or cognitive impairment severe enough to preclude giving informed consent to the study staff, or completing the survey instruments of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581724
07-068
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Beth Israel Medical Center
  • Vanderbilt University
Principal Investigator: Steven Passik, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP