Pain in Cancer Survivors
| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | January 25, 2012 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581724 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pain in Cancer Survivors | ||||
| Official Title ICMJE | Pain in Cancer Survivors | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | 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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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | January 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00581724 | ||||
| Other Study ID Numbers ICMJE | 07-068 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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