Janette L. Seville

Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer: The Project ENABLE II Randomized Controlled Trial

CONTEXT There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00253383.

A Controlled Trial of Methods for Managing Pain in Primary Care Patients With or Without Co-Occurring Psychosocial Problems

PURPOSE Pain, a common reason for visits to primary care physicians, is often not well managed. The objective of this study was to determine the effectiveness of pain management interventions suitable for primary care physicians. METHODS Patients from 14 rural primary care practices (47 physicians) who reported diverse pain problems with (n = 644) or without (n = 693) psychosocial problems were randomized to usual-care or intervention groups. All patients in the intervention group received information tailored to their problems and concerns (INFO). These patients’ physicians received feedback about their patients’ problems and concerns (FEED). A nurse-educator (NE) telephoned patients with pain and psychosocial problems to teach problem-solving strategies and basic pain management skills. Outcomes were assessed with the Medical Outcomes Study 36-Item Short-Form and the Functional Interference Estimate at baseline, 6 months, and 12 months. RESULTS Patients with pain and psychosocial problems randomized to INFOFEED+NE significantly improved on the bodily pain (P = .011), role physical (P = .025), vitality (P <.001), role emotional (P = .048), and the Functional Interference Estimate (P = .027) scales compared with usual-care patients at 6 months. These improvements were maintained at the 12-month assessment even though these patients had received, on average, only 3 telephone calls. Compared with usual-care patients, at 6 months patients who received INFOFEED alone experienced minimal improvements that were not sustained at the 12-month assessment. CONCLUSIONS For patients with pain and psychosocial problems, telephone-based assistance resulted in significant, sustained benefit in pain and psychosocial problems.

Panel-based pain management in primary care. a pilot study.

Although pain is an extremely common symptom presenting to primary care physicians, it frequently is not optimally managed. The purpose of this feasibility study was to develop and pilot-test an efficient, rapid assessment and management approach for pain in busy community practices. The intervention utilized the Dartmouth COOP Clinical Improvement System (DCCIS) and a telephone-based, nurse-educator intervention. Patients from four primary care practices in rural New Hampshire and Vermont were screened by mail for the presence of persistent pain. Patients with mild to severe pain were randomized to either the usual care control group (n = 383) or the intervention group (n = 320). Patients who reported pain but no psychosocial problems received a summary of identified problems and targeted educational material via mail (DCCIS). Patients who reported pain and psychosocial problems received the DCCIS intervention and calls from a nurse-educator who provided pain self-management strategies and a problem-solving approach for psychosocial problems. Post-treatment evaluation revealed that patients in the intervention group scored significantly better on the Pain, Physical, Emotional, and Social subscales of the SF-36 and on the total score of the Functional Interference Scale, as compared to a usual care control group. Feasibility and acceptability of the approach were demonstrated; however, the conclusions based on analyses of the post-treatment outcomes were tempered by baseline imbalances across groups.

Development and initial evaluation of a telephone-delivered, behavioral activation, and problem-solving treatment program to address functional goals of breast cancer survivors.

The purpose of this research was to develop and pilot test an intervention to optimize functional recovery for breast cancer survivors. Over two studies, 31 women enrolled in a goal-setting program via telephone. All eligible women enrolled (37% of those screened) and 66% completed all study activities. Completers were highly satisfied with the intervention, using it to address, on average, four different challenging activities. The longitudinal analysis showed a main effect of time for overall quality of life (F(5, 43.1) = 5.1, p = 0.001) and improvements in active coping (F (3, 31.7) = 4.9, p = 0.007), planning (F (3, 36.0) = 4.1, p = 0.01), reframing (F (3, 29.3) = 8.5, p < 0.001), and decreases in self-blame (F (3,31.6) = 4.3, p = 0.01). The intervention is feasible and warrants further study to determine its efficacy in fostering recovery and maximizing activity engagement after cancer treatment.

Ongoing Distress from Emotional Trauma Is Related to Pain, Mood, and Physical Function In a Primary Care Population

The relationship of trauma history to physical and emotional functioning in primary care pain patients was examined. Data were drawn from a mailed screening questionnaire for a larger study designed to evaluate an intervention for improving pain management in primary care. Results indicated that 50.4% of the pain patients reported experiencing at least one previous emotionally traumatic event. Further, 31% of patients with trauma history continued to be bothered by that experience. Finally, patients who continued to be significantly bothered by the trauma reported more pain, emotional distress, poorer social functioning, and more difficulty with engaging in their daily activities than did patients with either no trauma history or who had a trauma history but did not have bothersome thoughts of the trauma. These preliminary findings suggest that the experience of trauma alone was not related to additional impairments in physical and psychosocial functioning. However, the report that one continued to be bothered by thoughts of a trauma was associated with greater impairments in functioning.

Assessing functional impairment in elderly patients with chronic pain

This review focuses on assessment of chronic pain-related functional impairment in the elderly. The epidemiology of chronic pain and several factors that may effect impairment assessment in the elderly are addressed. Finally a number of specific functional assessment methods are described and critically evaluated.