https://clinicaltrials.gov/ct2/show/NCT00028249
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Process and Outcomes of Pain Management
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Purpose
This study will investigate the most effective approach for managing pain and providing palliative care (lessening of pain or symptoms).
Patients with advanced cancer who are enrolled in a National Cancer Institute (NCI) protocol and will undergo major surgery as part of their treatment may be eligible for this study.
Participants will be randomly assigned to pain management provided by either 1) their attending physician or 2) the Clinical Center's Pain and Palliative Care Service. Patients in the first group may be reassigned to the Pain and Palliative Care Service at any time during the study.
Participants will be interviewed every 3 months for as long as 1 year about their pain, its effect on several areas of their lives, changes in their needs, and how well they think their pain is being managed.. As the patients progress through the NCI study, they will meet regularly and as often as needed with either their attending physician or the Pain and Palliative Care team. Each interview will last about 20 to 30 minutes. With the patient's permission, the interviews will be tape recorded.
| Condition |
|---|
| Pain Neoplasm |
| Study Type: | Observational |
| Official Title: | A Randomized Study Evaluating the Process and Outcomes of the Pain and Palliative Care Team Intervention |
| Estimated Enrollment: | 298 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | December 2005 |
Pain is multidimensional. It is more than simply a physiologic or sensory response. Pain management programs are best developed by selecting interventions based on the individual's pain experience. Strategies with several mechanisms of action that complement each other might be selected to work together, thereby maximizing pain relief. The goal of palliative care is to achieve the highest possible quality of life for patients and their families through symptom control and attention to the whole patient, where physical, psychosocial, emotional, and spiritual dimensions are addressed. Provision of relief from pain and distressing symptoms is best served by a specialized interdisciplinary team with a comprehensive approach. The continuity of care for the patient and family is supported by communication and a strong partnership with the primary biomedical research team and the palliative care team.
Despite a number of descriptive studies exploring the effectiveness of specialized pain and palliative care teams, the paucity of good evaluations, with any comparative design, urgently needs to be addressed. This is a randomized, repeated measures, evaluation study to explore the effectiveness of the inpatient Pain and Palliative Care Service intervention. The data collected during this study will not only include outcomes of the intervention, but also patient and family perceptions of the care delivery process including issues surrounding communication with health care providers. Patients with advanced malignancies who are currently participating in NCI Surgery Branch protocols will be asked to participate in a pain and symptoms management evaluation study. Each patient and a designated family member will be asked to complete a series of questionnaires over time exploring physical, psychosocial and emotional correlates of pain and symptom management. Data will be analyzed using multivariate statistics.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients with advanced malignancies who are currently undergoing major surgical procedures in NCI Surgery Branch will be recruited to participate in a pain and symptoms management evaluation study.
Inclusion criteria are stated in the parent protocols.
Although each patient will be asked to identify a family member/significant other to participate in the study, patients will be eligible for inclusion regardless of whether they identify a family member for participation in the family questionnaires.
EXCLUSION CRITERIA:
All exclusions are stated in the NCI Surgery Branch parent protocols.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028249
| United States, Maryland | |
| National Institutes of Health Clinical Center (CC) | |
| Bethesda, Maryland, United States, 20892 | |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00028249 History of Changes |
| Other Study ID Numbers: | 020053 02-CC-0053 |
| Study First Received: | December 17, 2001 |
| Last Updated: | March 3, 2008 |
Keywords provided by National Institutes of Health Clinical Center (CC):
| Patient Satisfaction Self Efficacy Social Support |
Symptom Management Advanced Malignancies Pain Intervention |
ClinicalTrials.gov processed this record on April 06, 2017
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In addition to many well-known, established treatments, such as non-narcotic drugs (acetaminophen, aspirin and ibuprofen, for example) and narcotic medications (such as morphine and methadone), several newer methods are being used to treat chronic pain, with varying degrees of success.
a transcutaneous electrical nerve stimulation(TENS) device, which delivers a small electrical current to the skin surrounding the painful area(s).
marijuana for medical purposes
Spinal cord stimulation (SCS) involves implanting a small device beneath the skin that creates small electrical impulses near the base of the spine. Sometimes called a "pain pacemaker," SCS devices can now work via remote control, which allows the patient to adjust the level of the electrical signals in response to increasing or decreasing pain.
a "pain pump" or "drug pump" is a device implanted beneath the skin but this unit actually delivers medication directly to the fluid surrounding the spinal cord.
Use of a pain pump is not widespread because of the expense involved, but for certain patients, these devices have proven effective because the amount of medication needed is lower, which can reduce the negative side effects experienced with other drug-delivery techniques.
Unconventional treatments for chronic pain have grown significantly in the past two decades due to the growing acceptance of non-conventional medical methods, such as herbal supplements, yoga, meditation, etc. These various processes are collectively referred to as CAM, or complementary and alternative medicine. Briefly, a complementary technique will be used along with other pain-control treatments, while an alternative method is used in lieu of another type of treatment.
The list of CAM treatment types is long, but includes massage therapy, acupuncture, hypnosis, magnetic therapy, tai chi, and herbal or dietary supplements, to name a few.
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1. Growth in alternative therapies: While alternative therapies are certainly not new, they are an emerging trend in the U.S. as consumers embrace a natural lifestyle approach to health and wellness. The strong relief ratio achieved by these providers provides fuel to this trend and the popularity of these healthcare specialists will likely continue to grow. As of 2016, roughly 23% of adults trust homeopathic medicine, and 22% prefer alternative medicine to standard medical practices.
Further, Packaged Facts' survey found that among adults who suffered from debilitating pain within the past year, 68% visited a traditional healthcare professional, such as a family/general practice doctor or specialized doctor. However, nearly four out of 10 sufferers visited an alternative healthcare provider, such as an acupuncturist, chiropractor, massage therapist, etc.—a point that shows strong acceptance of alternative methods, whether used in place of traditional healthcare or in tandem.
2. Heavier focus on health and diet: Health and diet considerations play a key role in helping consumers manage their pain. Indeed, food and diet are considered part of 45% of pain sufferers' preferred approach to managing minor everyday pain, and 23% of their preferred approach to managing the "worst pain imaginable."
Further, consumers are hungry for information and tools that can help them lead healthier, more productive, more fulfilled lives—a hunger that only increases among those challenged by illness and pain because they are that much further removed from those intuitively human goals. Health and diet tools—ranging from vitamins and supplements to functional foods and beverages to organic and natural and beyond—have a significant role to play in satiating that hunger and achieving the universal goal of a more fulfilled life.
3. Exercise and weight management part of broader treatment: While weight management is a challenge for many, it is more prevalently so among those challenged by pain-centric illnesses and conditions. Illness and the pain associated with it can curtail activity, from everyday functions to specific behaviors closely associated with health and wellness. Exercising regularly takes a hit, as does the ability to control weight, and the likelihood of being overweight skyrockets.
Nevertheless, when paired with diet and healthy lifestyle efforts, incorporating moderate bouts of exercise to manage weight can be part of a broader pain management treatment strategy as excess weight can compound or exacerbate already existing pain.
4. Rising interest in homeopathic and functional pain medication: Consumers want products to be multi-functional, and pain relievers are no different. Pain sufferers exhibit significant interest in retail products that can help treat their pain while featuring value-added functional claims.
Makers and marketers should consider adding homeopathic or herbal qualities that can help users feel like they are doing something healthy for their entire body and not just eradicating their pain. The aromatherapy and essential oils market has gathered steam from the natural health and wellness megatrend.
5. Caffeine for more than just coffee: While the power of caffeine continues to drive sales of coffee and energy drinks, sating the appetites of consumers seeking an energy boost, it is also recognized as a pain remedy, particularly for migraines. For example, consider Excedrin Extra Strength, which promises that its "combination of active ingredients – Acetaminophen, Aspirin and Caffeine – offer a fast-acting, non-prescription headache pain reliever alternative."
Studies also suggest that caffeine has a broader scope of pain reduction potential, ranging from serving as a useful complement to opioid analgesic use among patients with advanced cancer to complementing acetaminophen in addressing acute back pain.
About the Report
Pain Management in the U.S.: Consumer Strategies, the first in a new segment for Packaged Facts, provides industry participants with an organized, insight-driven roadmap to navigating consumers' pain treatment and management strategies, helping to leverage market opportunity. The report focuses on how adults approach and treat their physical pain, emphasizing consumer survey analysis, including trends over time. The report studies two distinct groups: pain sufferers and adults who have selected illnesses/conditions strongly associated with physical pain and pain management. Demographic analysis of these groups is woven into report analysis. Content is further segmented by the nature of consumers' physical pain and chosen pain treatment methods and outcomes.
For additional information about Pain Management in the U.S.: Consumer Strategies, including purchase options, the abstract, table of contents, and related reports click: http://www.packagedfacts.com/Pain-Management-Consumer-10595686/.
About Packaged Facts
Packaged Facts, a division of MarketResearch.com, publishes market intelligence on a wide range of consumer market topics, including consumer demographics and shopper insights, consumer financial products and services, consumer goods and retailing, consumer packaged goods, and pet products and services. Packaged Facts also offers a full range of custom research services. Reports can be purchased at our company website and are also available through MarketResearch.com.
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Press Contact:
Daniel Granderson
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dgranderson@marketresearch.com
