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
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Prostate Cancer
Head and Neck Cancer
Lung Cancer
Behavioral: Telephone interview or self report survey.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pain in Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: May 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581724

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Beth Israel Medical Center
Vanderbilt University
Investigators
Principal Investigator: Steven Passik, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581724     History of Changes
Other Study ID Numbers: 07-068
Study First Received: December 21, 2007
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
breast cancer
Colorectal cancer
Prostate cancer
Head and Neck cancer
Lung cancer
cancer survivors
07-068
quality of life
Pain in cancer survivors

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014