- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581724
Pain in Cancer Survivors
January 25, 2012 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Descriptive statistics will be generated to describe the prevalence of pain and its psychosocial correlates.
Time Frame: 1 to 10 years post-treatment completion
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1 to 10 years post-treatment completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Passik, PhD, Memorial Sloan Kettering Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
January 26, 2012
Last Update Submitted That Met QC Criteria
January 25, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Prostatic Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Head and Neck Neoplasms
- Prostatic Neoplasms
- Colorectal Neoplasms
Other Study ID Numbers
- 07-068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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