Examples

Development and Validation of a Variant of the Treatment Outcomes in Pain Survey (TOPS) in Patients with Cancer-Related Pain

Student

Aimee L. Smith, Class of 2005, Box 215
Email: als268@psu.edu

Faculty Advisor

Rosemary Polomano, PhD, RN, FAAN
Assistant Professor, Department of Anesthesiology
Assistant Professor, Department of Neuroscience & Anatomy
Senior Researcher, Department of Nursing
Penn State College of Medicine
717-531-4085
rpolomano@psu.edu

Research Period

May 27- August 2, 2002

Objectives

  1. Assess reliability and validity of the TOPS instrument and subscale variability in chronic cancer pain patients.
  2. Determine the effect of various treatments on The Treatment Outcomes Pain Survey (TOPS).

 

Background

Cancer patients are almost inevitably ailed with chronic pain. It has been estimated that approximately sixty-seven percent of patients with metastatic cancer experience pain (Cleveland, 1994). Even more astonishing is the World Health Organization Cancer Pain Relief Program report that approximately 5 million people worldwide experience pain relating to cancer on a daily basis, with 25% of them dying without relief from their pain. Investigators have concluded that with 27-74% of patients receiving inadequate cancer pain treatment, the heterogeneity of patient groups and treatment regimens may account for the insufficiency in assessing and treating cancer-related pain (de Wit, 1999). Because pain is a subjective experience, each individual is influenced differently by psychosocial factors such as age, sex, culture, and personality. These factors each must be assessed adequately in order to measure the effectiveness of a pain treatment regimen.

Adequate treatment of chronic pain in cancer patients is necessary to ensure that patients are able to continue to improve their quality of life and function in society. In order to treat chronic pain successfully there must be adequate ways to measure the effectiveness of treatments in reducing pain and symptoms relating to the impairments caused by chronic pain. To date most assessment tools used by physicians have been shown to be effective in measuring pain intensity (a unidimensional construct), but fail to adequately measure the many other 'multi-dimensional' facets of pain. The Medical Outcomes Study (SF-36), has been validated to measure pain in large populations that do not show a preponderance of one single medical condition. But the SF-36 has been shown ineffective in tracking pain in patients with specific conditions. The SF-36 is also ineffective in tracking pain during the course of pain treatments (Rogers, 2000).

The Treatment Outcomes Pain Survey (TOPS) is an extension of the SF-36 and has been validated as multi-dimensional pain measure for patients with chronic nonmalignant pain (Rogers, 2000). The TOPS survey adequately assesses the multidisciplinary treatments relating to chronic pain. Previously, it has been shown that the effectiveness of treatments for cancer-related pain was more determined by the choice of assessment tool, rather than the choice of pain treatment itself (de Wit, 1999). With the ever-increasing need for more successful measures of effectiveness of cancer-related pain treatments, it is our hope to validate the TOPS in patients with cancer-related pain.

Methods

Informed consent will be obtained from all eligible subjects. Subjects will be 200 new adult (18+) patients presenting to the Outpatient Hematology-Oncology, Chronic Pain Management Clinic, and Radiation Therapy at the Hershey Medical Center with cancer-related pain who are regularly taking analgesics will be asked to complete the TOPS on their initial or a subsequent follow-up visit. Any patient whose attending physician feels should not participate will be excluded. An interim analysis will be conducted to determine if the sample size requires expansion.

Instructions as to how to complete the TOPS form will be provided during the initial interview. Data on demographic variables, cancer diagnosis, pain sites associated with metastatic disease, cancer treatment, current analgesic therapy, and average pain intensity (Numeric Rating Scale (0-10) will be collected. Subjects will be asked to complete the questionnaire (estimated completion time: 30-60 minutes). Patients will be instructed that if there is any information requested on the questionnaire that they do not feel comfortable providing, they may decline to answer any question.

Correlation statistics will be used to describe relationships among variables. It is anticipated that approximately 30 subjects per subscale will be required to independently validate the 14 subscales using a factor analysis. Information collected and analyzed will be sent to the New England Medical Center to Daniel Carr, MD and William Rogers, PhD and shared with Allen Burton, MD, M.D. Anderson Cancer Center, Houston TX without patient identification information. All survey questionnaires will remain at this facility and will stored in a locked investigator office.

Student's Responsibilities

  1. Review literature on current measurements of cancer pain and their effectiveness on designing treatment regimens.
  2. Screen subjects.
  3. Obtain informed consent and administer surveys to subjects as outlined in Methods Section.
  4. Participate with primary investigator, in statistical analysis of results using SPSS.
  5. Prepare draft and final MSR paper.

 

Sponsor's Responsibilities

  1. Provide information and guidance in subject screening and survey distribution.
  2. Provide access to necessary equipment and resources.
  3. Perform statistical analysis on obtained results.
  4. Review draft and final MSR paper.

 

References

Cleeland CS, Gonin R, Hatfield AK, et al. Pain and its treatment in outpatients with metastatic cancer. New England Journal of Medicine 1994;330:592-596.

Daly L. Cancer pain assessment. Australian Nursing Journal 1999;6(10):C1-C4.

De Wit R, Van Dam F, Huijer Abu-Saad H, Loonstra S, Zanelt L, Van Buuren A, Van der Heijden K. Empirical comparison of frequently used measures to evaluate pain treatment in cancer patients with chronic pain. J Clin Oncol 1999b;17:1280-1287.

De Wit R, Van Dam F, Loonstra S, Zandbelt L, Van Buuren A, Van der Heijden K, Leenhouts G, Huijer Abu-Saad H. The amsterdam pain management index compared to eight frequently used outcome measures to evaluate the adequacy of pain treatment in cancer patients with chronic pain. Pain 2001;91:339-349.

Rogers W, Wittink H, Wagner A, Cynn D, Carr D. Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented sf-36. Pain Medicine 2000;1:44-54.

Rogers W, Wittink H, Ashburn M, Cynn D, Carr D. Using the "TOPS," an outcomes instrument for multidisciplinary outpatient pain treatment. Pain Medicine 2000;1:55-67.

Turk D, Sist T, Okifuji A, Miner M, Florio G, Harrison P, Massey J, Lema M, Zevon M. Adaptation to metastatic caner pain, regional/local cancer pain and non-cancer pain: role of psychological and behavioral factors. Pain 1998;74:247-256.