Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database.

BACKGROUND: Hopefulness, whether inherently present (dispositional hope) or augmented (by enhancement techniques), may affect outcomes. This study was performed to determine the association of dispositional hope with survival among patients diagnosed with advanced cancer. METHODS: Data from ENABLE (Educate, Nurture, Advise, Before Life Ends), a palliative care intervention, were reanalyzed to determine the association of higher dispositional hope and patient survival. This was a secondary analysis of data combined from the ENABLE II and ENABLE III randomized controlled trials (RCTs) with respect to dispositional hope and survival. A dispositional hope index was created from 3 hope items from 2 validated baseline questionnaires. Dispositional hope and survival data were collected during the 2 RCTs. In ENABLE II, participants were randomly assigned to the ENABLE intervention or to usual care. In ENABLE III, participants were randomly assigned to receive the intervention immediately or 12 weeks after enrollment. RESULTS: In all, 529 persons were included in Cox proportional hazards regression analyses to model the effects of dispositional hope on survival. An initial analysis without covariates yielded a significant effect of hope (Wald statistic, 8.649; hazard ratio, 0.941; confidence interval, 0.904-0.980; P = .003), such that higher dispositional hope was associated with longer survival. In a subsequent analysis that included all covariates, the effect of dispositional hope approached statistical significance (Wald statistic, 2.96; hazard ratio, 0.933; confidence interval, 0.863-1.010; P = .085). CONCLUSIONS: Higher levels of dispositional hope were associated with longer survival in patients with advanced cancer. Prospective trials are needed to determine the effects of dispositional and augmented hope on the outcomes of patients with advanced cancer.

Health Through Activity: Initial Evaluation of an In-Home Intervention for Older Adults With Cancer.

OBJECTIVE: The objective of this study was to assess the feasibility of conducting a future full-scale trial to test the efficacy of an in-home occupational therapy intervention designed to reduce disability in older adult cancer survivors. METHOD: Participants reporting activity limitations during or after cancer treatment were enrolled in a Phase 1 pilot randomized controlled trial comparing the 6-wk intervention (n = 30) to usual care (n = 29). Descriptive data on retention rates were collected to assess feasibility of intervention and study procedures. Potential efficacy was explored through participants' self-reported disability, quality of life, activity level, and behavioral activation at 0, 8, and 16 wk after enrollment. RESULTS: Retention rates were high regarding completion of the intervention (90%) and outcome assessments (90% of usual-care participants and 80% of intervention participants). Outcomes consistently favored the intervention group, although group differences were small. CONCLUSION: The procedures were feasible to implement and acceptable to participants.

Metaanalysis of the relationship between violent video game play and physical aggression over time.

To clarify and quantify the influence of video game violence (VGV) on aggressive behavior, we conducted a metaanalysis of all prospective studies to date that assessed the relation between exposure to VGV and subsequent overt physical aggression. The search strategy identified 24 studies with over 17,000 participants and time lags ranging from 3 months to 4 years. The samples comprised various nationalities and ethnicities with mean ages from 9 to 19 years. For each study we obtained the standardized regression coefficient for the prospective effect of VGV on subsequent aggression, controlling for baseline aggression. VGV was related to aggression using both fixed [ß = 0.113, 95% CI = (0.098, 0.128)] and random effects models [ß = 0.106 (0.078, 0.134)]. When all available covariates were included, the size of the effect remained significant for both models [ß = 0.080 (0.065, 0.094) and ß = 0.078 (0.053, 0.102), respectively]. No evidence of publication bias was found. Ethnicity was a statistically significant moderator for the fixed-effects models (P ≤ 0.011) but not for the random-effects models. Stratified analyses indicated the effect was largest among Whites, intermediate among Asians, and nonsignificant among Hispanics. Discussion focuses on the implications of such findings for current debates regarding the effects of violent video games on physical aggression.

The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer.

OBJECTIVE: Randomized controlled trials (RCTs) of early palliative care interventions in advanced cancer have positively impacted patient survival, yet the mechanisms remain unknown. This secondary analysis of 2 RCTs assessed whether an early palliative care intervention moderates the relationship between depressive symptoms and survival. METHOD: The relationships among mood, survival, and early palliative care intervention were studied among 529 advanced cancer patients who participated in 2 RCTs. The first (N = 322) compared intervention versus usual care. The second (N = 207) compared early versus delayed intervention (12 weeks after enrollment). The interventions included an in-person consultation, weekly nurse coach-facilitated phone sessions, and monthly follow-up. Mood was measured using the Center for Epidemiologic Studies-Depression (CES-D) scale. Cox proportional hazard analyses were used to examine the effects of baseline CES-D scores, the intervention, and their interaction on mortality risk while controlling for demographic variables, cancer site, and illness severity. RESULTS: The combined sample was 56% male (M = 64.7 years). Higher baseline CES-D scores were significantly associated with greater mortality risk (hazard ratio [HR] = 1.042, 95% confidence interval [CI] [1.017, 1.067], p = .001). However, participants with higher CES-D scores who received the intervention had a lower mortality risk (HR = .963, CI [0.933, 0.993], p = .018) even when controlling for demographics, cancer site, and illness-related variables. CONCLUSION: This study is the first to demonstrate that patients with advanced cancer who also have depressive symptoms benefit the most from early palliative care. Future research should be devoted to exploring the mechanisms responsible for these relationships. (PsycINFO Database Record

Family Caregiver Depressive Symptom and Grief Outcomes From the ENABLE III Randomized Controlled Trial.

CONTEXT: Little is known about whether early palliative care (EPC) support for family caregivers (CGs) impacts depressive symptoms and grief after care recipients die. OBJECTIVES: To assess after-death CG depressive symptom and grief scores for early compared to delayed group CGs. METHODS: We conducted a randomized controlled trial (10/2010-9/2013) of an EPC telehealth intervention for CGs (n = 123) initiated at the time of care recipients' advanced cancer diagnosis (early group) or 12 weeks later (delayed group) in a rural comprehensive cancer center, affiliated clinics, and a Veterans Administration medical center. The ENABLE [Educate, Nurture, Advise, Before Life Ends] CG intervention consisted of three weekly sessions, monthly follow-up, and a bereavement call. CGs completed the Center for Epidemiological Study-Depression (CES-D) scale and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients' deaths. Crude and covariate-adjusted between-group differences were estimated and tested using general linear models. RESULTS: For care recipients who died (n = 70), 44 CGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depressive symptom scores (CES-D) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean complicated grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Adjusted between-group differences were not statistically significant (CES-D: d = 0.07, P = 0.88; PG13: d = -0.21, P = 0.51). CONCLUSION: CGs' depressive symptom and complicated grief scores 8-12 weeks after care recipients' deaths were not statistically different based on the timing of EPC support. The impact of timing of CG EPC interventions on CGs bereavement outcomes requires further investigation.

Associations between advanced cancer patients' survival and family caregiver presence and burden.

We conducted a randomized controlled trial (RCT) of an early palliative care intervention (ENABLE: Educate, Nurture, Advise, Before Life Ends) for persons with advanced cancer and their family caregivers. Not all patient participants had a caregiver coparticipant; hence, we explored whether there were relationships between patient survival, having an enrolled caregiver, and caregiver outcomes prior to death. One hundred and twenty-three patient-caregiver dyads and 84 patients without a caregiver coparticipant participated in the ENABLE early versus delayed (12 weeks later) RCT. We collected caregiver quality-of-life (QOL), depression, and burden (objective, stress, and demand) measures every 6 weeks for 24 weeks and every 3 months thereafter until the patient's death or study completion. We conducted survival analyses using log-rank and Cox proportional hazards models. Patients with a caregiver coparticipant had significantly shorter survival (Wald = 4.31, HR = 1.52, CI: 1.02-2.25, P = 0.04). After including caregiver status, marital status (married/unmarried), their interaction, and relevant covariates, caregiver status (Wald = 6.25, HR = 2.62, CI: 1.23-5.59, P = 0.01), being married (Wald = 8.79, HR = 2.92, CI: 1.44-5.91, P = 0.003), and their interaction (Wald = 5.18, HR = 0.35, CI: 0.14-0.87, P = 0.02) were significant predictors of lower patient survival. Lower survival in patients with a caregiver was significantly related to higher caregiver demand burden (Wald = 4.87, CI: 1.01-1.20, P = 0.03) but not caregiver QOL, depression, and objective and stress burden. Advanced cancer patients with caregivers enrolled in a clinical trial had lower survival than patients without caregivers; however, this mortality risk was mostly attributable to higher survival by unmarried patients without caregivers. Higher caregiver demand burden was also associated with decreased patient survival.

Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial.

PURPOSE: To determine the effect of early versus delayed initiation of a palliative care intervention for family caregivers (CGs) of patients with advanced cancer. PATIENTS AND METHODS: Between October 2010 and March 2013, CGs of patients with advanced cancer were randomly assigned to receive three structured weekly telephone coaching sessions, monthly follow-up, and a bereavement call either early after enrollment or 3 months later. CGs of patients with advanced cancer were recruited from a National Cancer Institute cancer center, a Veterans Administration Medical Center, and two community outreach clinics. Outcomes were quality of life (QOL), depression, and burden (objective, stress, and demand). RESULTS: A total of 122 CGs (early, n = 61; delayed, n = 61) of 207 patients participated; average age was 60 years, and most were female (78.7%) and white (92.6%). Between-group differences in depression scores from enrollment to 3 months (before delayed group started intervention) favored the early group (mean difference, -3.4; SE, 1.5; d = -.32; P = .02). There were no differences in QOL (mean difference, -2; SE, 2.3; d = -.13; P = .39) or burden (objective: mean difference, 0.3; SE, .7; d = .09; P = .64; stress: mean difference, -.5; SE, .5; d = -.2; P = .29; demand: mean difference, 0; SE, .7; d = -.01; P = .97). In decedents' CGs, a terminal decline analysis indicated between-group differences favoring the early group for depression (mean difference, -3.8; SE, 1.5; d = -.39; P = .02) and stress burden (mean difference, -1.1; SE, .4; d = -.44; P = .01) but not for QOL (mean difference, -4.9; SE, 2.6; d = -.3; P = .07), objective burden (mean difference, -.6; SE, .6; d = -.18; P = .27), or demand burden (mean difference, -.7; SE, .6; d = -.23; P = .22). CONCLUSION: Early-group CGs had lower depression scores at 3 months and lower depression and stress burden in the terminal decline analysis. Palliative care for CGs should be initiated as early as possible to maximize benefits.

Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial.

PURPOSE: Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use. PATIENTS AND METHODS: Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location). RESULTS: Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60). CONCLUSION: Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.

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.

A longitudinal study of risk-glorifying video games and behavioral deviance.

Character-based video games do more than allow one to practice various kinds of behaviors in a virtual environment; they allow one to practice being a different kind of person. As such, we propose that games can alter self-perceptions of personal characteristics, attitudes, and values with broad consequences for behavior. In a multiwave, longitudinal study of adolescents, we examined the extent to which play of mature-rated, risk-glorifying (MRRG) games was associated with increases in alcohol use, cigarette smoking, aggression, delinquency, and risky sex as a consequence of its effects on personality, attitudes, and affiliations indicative of increased tolerance of deviance. Participants were selected with random-digit-dial procedures and followed for 4 years. Data were analyzed with linear mixed modeling to assess change over time and structural equation modeling with latent variables to test hypothesized mediational processes. Among those who play video games, playing MRRG games was associated with increases in all measures of behavioral deviance. Mediational models support the hypothesis that these effects are in part a consequence of the effects of such gameplay on sensation seeking and rebelliousness, attitudes toward deviant behavior in oneself and others, and affiliation with deviant peers. Effects were similar for males and females and were strongest for those who reported heavy play of mature-rated games and games that involved protagonists who represent nonnormative and antisocial values. In sum, the current research supports the perspective that MRRG gameplay can have consequences for deviant behavior broadly defined by affecting the personality, attitudes, and values of the player.

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial.

Computer-based depression interventions lacking live therapist support have difficulty engaging users. This study evaluated the usability, acceptability, credibility, therapeutic alliance and efficacy of a stand-alone multimedia, interactive, computer-based Problem Solving Treatment program (ePST™) for depression. The program simulated live treatment from an expert PST therapist, and delivered 6 ePST™ sessions over 9weeks. Twenty-nine participants with moderate-severe symptoms received the intervention; 23 completed a minimally adequate dose of ePST™ (at least 4 sessions). Program usability, acceptability, credibility, and therapeutic alliance were assessed at treatment midpoint and endpoint. Depressive symptoms and health-related functioning were assessed at baseline, treatment midpoint (4weeks), and study endpoint (10weeks). Depression outcomes and therapeutic alliance ratings were also compared to previously published research on live PST and computer-based depression therapy. Participants rated the program as highly usable, acceptable, and credible, and reported a therapeutic alliance with the program comparable to that observed in live therapy. Depressive symptoms improved significantly over time. These findings also provide preliminary evidence that ePST™ may be effective as a depression treatment. Larger clinical trials with diverse samples are indicated.

Reliability and validity of the valued activity inventory for adults with cancer.

The authors assessed the psychometric properties of the Valued Activity Inventory for Adults With Cancer (VAI-AC), a self-report instrument that measures activity limitations. Participants included 50 older adults undergoing chemotherapy who completed the VAI-AC and measures of physical and mental function, symptom intensity, and mood 3 days before and the day of chemotherapy. Test-retest reliability was assessed by determining the average number of items for which the importance of an activity was rated consistently and by calculating the intraclass correlation coefficient (ICC) for the first and second VAI-AC scores. Convergent validity was assessed by correlating the VAI-AC scores with the other measures. Participants consistently rated the importance of 90% of the items. The 72-hour test-retest reliability ICC was 0.67. Participants with fewer activity limitations indicated better physical function (r = 0.58, p < .001), better mental function (r = 0.55, p < .001), lower symptom intensity (r = -0.57, p < .001), and fewer depressive symptoms (r = -0.68, p < .001). The VAI-AC demonstrated evidence of test-retest reliability and convergent validity in this convenience sample of older adults undergoing chemotherapy for cancer.

Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy.

OBJECTIVE: Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. METHODS: A pilot RCT of a telephone-delivered Problem-solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n = 15) and usual care (n = 16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 and 12 weeks. RESULTS: Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life, and emotional state favored the PST-OT condition. CONCLUSION: This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state.

A pilot study of activity engagement in the first six months after stem cell transplantation.

UNLABELLED: PRPOSE/OBJECTIVES: to describe the natural pace and pattern of activity resumption in the first six months after stem cell transplantation (SCT). DESIGN: longitudinal, descriptive survey. SETTING: bone marrow transplantation program of a National Cancer Institute-designated comprehensive cancer center in the northeastern United States. SAMPLE: 18 men and 18 women who underwent either autologous (83%) or allogeneic (17%) transplantation. METHODS: participants were surveyed 30 days, 100 days, and six months after SCT. Descriptive statistics were followed by exploratory linear mixed modeling with factors of time, gender, and the interaction between time and gender. MAIN RESEARCH VARIABLES: a modified checklist version of the Activity Card Sort was used to measure activity retention. FINDINGS: participants generally were performing 49% of their usual activities 30 days after transplantation, 70% of their premorbid activities 100 days after transplantation, and 77% of their premorbid activities six months after transplantation. Level of activity engagement increased over time, with the greatest changes observed from 30-100 days after SCT. Men retained more of their activities than women in the domains of low physical-demand leisure and social activities. CONCLUSIONS: rehabilitation screening may be most helpful in the period from 100 days to six months, when activity levels begin to plateau. Activity recovery may differ for men and women; future research should explore how this could affect rehabilitation needs. IMPLICATIONS FOR NURSING: nurses can use structured surveys to explore and promote patients' satisfaction with and ability to engage in daily activities and ensure appropriate referrals to rehabilitation during recovery from SCT.

Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer.

OBJECTIVE: Caregivers of patients with advanced cancer experience physical and emotional strain that can raise their own risk for morbidity and mortality. This analysis was performed to determine whether ENABLE II, a patient-focused palliative care intervention that increased patients' quality of life, reduced symptom intensity, and lowered depressed mood compared to usual care, would affect caregiver burden. METHOD: Caregivers of patients with advanced cancer from the parent study completed a caregiver burden scale and patients completed quality of life, symptom intensity, and depressed mood measures. Data were collected at baseline, 1 month, and every 3 months thereafter until patient death or the study ended. Decedents' caregivers were asked to complete an after-death interview regarding the quality of care that the patient received. RESULTS: There were no significant differences in caregiver burden between intervention and usual care conditions. Follow-up analyses showed that higher caregiver objective burden and stress burden were related to lower patient quality of life, higher symptom intensity, and higher depressed mood. Caregivers who perceived that patients had unmet needs at end of life reported higher objective burden, and those who perceived that patients were not treated with respect reported higher demand burden. SIGNIFICANCE OF RESULTS: The results indicate that a successful patient-focused intervention did not have a similar beneficial effect on caregiver burden. Future interventions should focus on caregivers as well as patients, with particular attention to caregivers' perceptions of patient care, and seek to change both negative and positive effects of informal caregiving.

Practical Interests, Relevant Alternatives, and Knowledge Attributions: an Empirical Study.

In defending his interest-relative account of knowledge, Jason Stanley relies heavily on intuitions about several bank cases. We experimentally test the empirical claims that Stanley seems to make concerning our common-sense intuitions about these cases. Additionally, we test the empirical claims that Jonathan Schaffer seems to make, regarding the salience of an alternative, in his critique of Stanley. Our data indicate that neither raising the possibility of error nor raising stakes moves most people from attributing knowledge to denying it. However, the raising of stakes (but not alternatives) does affect the level of confidence people have in their attributions of knowledge. We argue that our data impugn what both Stanley and Schaffer claim our common-sense judgments about such cases are.

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.

Problem-solving treatment and coping styles in primary care for minor depression.

Research was undertaken to compare problem-solving treatment for primary care (PST-PC) with usual care for minor depression and to examine whether treatment effectiveness was moderated by coping style. PST-PC is a 6-session, manual-based, psychosocial skills intervention. A randomized controlled trial was conducted in 2 academic, primary care clinics. Those subjects who were eligible were randomized (N = 151), and 107 subjects completed treatment (57 PST-PC, 50 usual care) and a 35-week follow-up. Analysis with linear mixed modeling revealed significant effects of treatment and coping, such that those in PST-PC improved at a faster rate and those initially high in avoidant coping were significantly more likely to have sustained benefit from PST-PC.

Watchful waiting for minor depression in primary care: remission rates and predictors of improvement.

OBJECTIVES: The objectives of this study were to determine remission rates and predictors of improvement for minor depression following a 1-month watchful waiting period in primary care and to describe the watchful waiting processes. METHODS: Prior to randomization into a clinical trial for minor depression, 111 participants were entered into a 1-month watchful waiting period. Depression severity and predictors of improvement were measured at the start of watchful waiting. At the end of watchful waiting, remission rates were calculated and predictor variables were analyzed for their contribution toward predicting improvement. RESULTS: Remission rates were low, ranging from 9% to 13%, depending on the measure. Avoidant coping style and frequency of engaging in active pleasant events at baseline accounted for the majority of change in depression. During watchful waiting, about one fifth of the sample (21%) had at least one contact with their physician and 27% reported using self-initiated treatments. CONCLUSIONS: There is a low likelihood of spontaneous remission for treatment-seeking samples with minor depression in primary care. An avoidant coping style seriously interferes with remission, and engaging in regular active pleasant events confers an advantage. Feasible interventions for primary care that promote activity and decrease avoidant coping styles may improve outcomes. These findings may not generalize to community and non-treatment-seeking samples.