Pain in Cancer Survivors

NCT ID: NCT00581724

Last Updated: 2012-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-01-31

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.

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.

Conditions

Breast Cancer; Colorectal Cancer; Prostate Cancer; Head and Neck Cancer; Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Telephone interview or self report survey.

Intervention Type: BEHAVIORAL

We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Medical Center

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Passik, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

07-068

Identifier Type: -

Identifier Source: org_study_id