Breast CancerNCT00581724
Pain in Cancer Survivors
An observational study of Breast Cancer and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Telephone interview or self report survey.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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.
- Being tested
- Telephone interview or self report survey.
- Keywords
- breast cancer, Colorectal cancer, Prostate cancer, Head and Neck cancer, Lung cancer, cancer survivors, 07-068, quality of life, Pain in cancer survivors
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interview or self report survey.Behavioural
We estimate that the completion time for the telephone interview or self-report survey will be 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telephone interview or self report survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistics will be generated to describe the prevalence of pain and its psychosocial correlates.
Measured: 1 to 10 years post-treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Medical Center, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Steven Passik, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581724
- Sponsor's protocol ID
- 07-068
- Status last verified
- Jan 2012
- First submitted
- 21 Dec 2007
- Last updated
- 26 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Cancer Survivors
- ClinicalTrials.gov ID
- NCT00581724
- Acronym / sponsor ID
- 07-068
- Keywords
- breast cancer, Colorectal cancer, Prostate cancer, Head and Neck cancer, Lung cancer, cancer survivors, 07-068, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Beth Israel Medical Center, Vanderbilt University
- Study start
- May 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Telephone interview or self report survey.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
Primary outcome
Descriptive statistics will be generated to describe the prevalence of pain and its psychosocial correlates.
Time frame: 1 to 10 years post-treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Passik, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.