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.

Using Self-Guided Treatment Software (ePST) to Teach Clinicians How to Deliver Problem-Solving Treatment for Depression.

Problem-solving treatment (PST) offers a promising approach to the depression care; however, few PST training opportunities exist. A computer-guided, interactive media program has been developed to deliver PST electronically (ePST), directly to patients. The program is a six-session, weekly intervention modeled on an evidence-based PST protocol. Users are guided through each session by a clinician who is presented via hundreds of branching audio and video clips. Because expert clinician behaviors are modeled in the program, not only does the ePST program have the potential to deliver PST to patients but it may also serve as a training tool to teach clinicians how to deliver PST. Thirteen social workers and trainees used ePST self-instructionally and subsequently attended a day-long workshop on PST. Participants' PST knowledge level increased significantly from baseline to post-ePST (P = .001) and did not increase significantly further after attending the subsequent workshop. Additionally, attending the workshop did not significantly increase the participants' skill at performing PST beyond the use of the ePST program. Using the ePST program appears to train novices to a sufficient level of competence to begin practicing PST under supervision. This self-instructional training method could enable PST for depression to be widely disseminated, although follow-up supervision is still required.

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.

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.

OBJECTIVE: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS: Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. SIGNIFICANCE OF RESULTS: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

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.

Psychometric update of the Functional Interference Estimate: a brief measure of pain functional interference.

The Functional Interference Estimate (FIE) is a brief, 5-item self-report measure that assesses the degree to which pain interferes with daily functioning. While the FIE has demonstrated reliability and validity with a small normative sample, not much is known about its reliability and validity with a broad sample of individuals with pain. The current study presents FIE score means, variability estimates, reliability and validity data based on a large sample (n = 1,337) of primary care patients who report problematic pain. The FIE has excellent internal consistency and appears to have strong convergent validity with other well-established measures of function (e.g., SF-36 and Dartmouth COOP Charts). Because of its brevity and flexibility, the FIE may be a useful self-report measure of pain functional interference in clinical research on pain.

Training residents in problem-solving treatment of depression: a pilot feasibility and impact study.

BACKGROUND AND OBJECTIVES: Primary care patients with depression may prefer or require a non-pharmacological treatment such as counseling. We investigated the feasibility of teaching family medicine residents an evidence-based brief counseling intervention for depression (Problem-solving Treatment of Depression for Primary Care [PST-PC]). METHODS: Eleven residents over 3 consecutive years were provided a brief training program in PST-PC. Residents were evaluated for skill acquisition, changes in self efficacy, intentions to improve their care for depression, and post-residency integration of PST-PC into their daily practice. RESULTS: Trainees met established criteria for competency to administer PST-PC. They improved to moderate-to-high levels of self efficacy for treating depression, including for their counseling skills, and in their intentions to improve their depression management. At up to 3 years post residency, 90% indicated they were using PST-PC, often in a modified form, and also for illnesses other than depression. They indicated they would recommend the training to new residents. CONCLUSIONS: The PST-PC training program evaluated in this study is feasible in residency training and appears to influence practice post residency. These findings warrant continued investigation of this training program with a larger sample of residents and evaluation of outcomes with depressed patients treated with PST-PC in real-world practice settings.

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.