Sangchoon Jeon

Effect of a Cognitive Behavioral Intervention on Reducing Symptom Severity During Chemotherapy

PURPOSE To describe a randomized trial of a cognitive behavioral intervention on reducing symptom severity among patients diagnosed with solid tumors and undergoing a first course of chemotherapy and to determine whether the intervention had an additive or interactive effect on symptom severity in the presence of supportive care medications. PATIENTS AND METHODS Patients (N = 237) were accrued from comprehensive and community cancer centers, interviewed, and randomly assigned to either the experimental intervention (n = 118) or conventional care (n = 119). A symptom severity index, based on summed severity scores across 15 symptoms, was the primary outcome. Each patients site of cancer, stage at diagnosis, chemotherapy protocols, and use of supportive medications were learned from medical records. RESULTS Groups were equivalent at baseline, and attrition by characteristics by group was not different. The proportion of patients not receiving chemotherapy at 10 and 20 weeks did not differ by group. At the 10- and 20-week observations, there was a significant interaction between the experimental group and baseline symptom severity. Patients in the experimental group who entered the trial with higher symptom severity reported significantly lower severity at 10 and 20 weeks. Controlling for chemotherapy treatment status at follow-up and supportive care medications did not alter the effect of the experimental intervention. CONCLUSION Compared with conventional care alone, the experimental intervention was effective among patients who entered the trial with higher levels of symptom severity. Age, sex, site or stage of cancer, and supportive medications did not modify the effect of this cognitive behavioral intervention on symptom severity.

Internet Psycho-Education Programs Improve Outcomes in Youth With Type 1 Diabetes

OBJECTIVE The purpose of this study was to determine the efficacy of two Internet-based psycho-educational programs designed to improve outcomes for youth with type 1 diabetes transitioning to adolescence. RESEARCH DESIGN AND METHODS The study was a multisite clinical trial of 320 youth (aged 11–14 years; 37% minority; 55% female) randomized to one of two Internet-based interventions: TeenCope or Managing Diabetes. Primary outcomes were HbA1c and quality of life (QOL). Secondary outcomes included coping, self-efficacy, social competence, self-management, and family conflict. Data were collected at baseline and after 3, 6, and 12 months online. Youth were invited to cross over to the other program after 12 months, and follow-up data were collected at 18 months. Analyses were based on mixed models using intent-to-treat and per-protocol procedures. RESULTS Youth in both groups had stable QOL and minimal increases in HbA1c levels over 12 months, but there were no significant differences between the groups in primary outcomes. After 18 months, youth who completed both programs had lower HbA1c (P = 0.04); higher QOL (P = 0.02), social acceptance (P = 0.01), and self-efficacy (P = 0.03) and lower perceived stress (P = 0.02) and diabetes family conflict (P = 0.02) compared with those who completed only one program. CONCLUSIONS Internet interventions for youth with type 1 diabetes transitioning to adolescence result in improved outcomes, but completion of both programs was better than only one, suggesting that these youth need both diabetes management education and behavioral interventions. Delivering these programs via the Internet represents an efficient way to reach youth and improve outcomes.

Detecting a Clinically Meaningful Change in Tic Severity in Tourette Syndrome: A Comparison of Three Methods

OBJECTIVE To compare three statistical strategies for classifying positive treatment response based on a dimensional measure (Yale Global Tic Severity Scale [YGTSS]) and a categorical measure (Clinical Global Impression-Improvement [CGI-I] scale). METHOD Subjects (N=232; 69.4% male; ages 9-69years) with Tourette syndrome or chronic tic disorder participated in one of two 10-week, randomized controlled trials comparing behavioral treatment to supportive therapy. The YGTSS and CGI-I were rated by clinicians blind to treatment assignment. We examined the percent reduction in the YGTSS-Total Tic Score (TTS) against Much Improved or Very Much Improved on the CGI-I, computed a signal detection analysis (SDA) and built a mixture model to classify dimensional response based on the change in the YGTSS-TTS. RESULTS A 25% decrease on the YGTSS-TTS predicted positive response on the CGI-I during the trial. The SDA showed that a 25% reduction in the YGTSS-TTS provided optimal sensitivity (87%) and specificity (84%) for predicting positive response. Using a mixture model without consideration of the CGI-I, the dimensional response was defined by 23% (or greater) reduction on the YGTSS-TTS. The odds ratio (OR) of positive response (OR=5.68, 95% CI=[2.99, 10.78]) on the CGI-I for behavioral intervention was greater than the dimensional response (OR=2.86, 95% CI=[1.65, 4.99]). CONCLUSION A 25% reduction on the YGTSS-TTS is highly predictive of positive response by all three analytic methods. For trained raters, however, tic severity alone does not drive the classification of positive response. Clinicaltrials.gov identifiers: NCT00218777; NCT00231985.

Coping skills training for parents of children with type 1 diabetes: 12-month outcomes.

Background:Although it is recognized that caring for a child with Type 1 diabetes (T1D) is stressful for parents, few interventions have been developed and tested for this population. Objectives:The aim of this study was to compare a group educational intervention for parents of children with T1D to a coping skills training intervention. Methods:Parents of children with T1D were randomized to the group educational (n = 106) or coping skills training (n = 75) conditions. Parents completed measures of family conflict, responsibility for treatment, coping, and quality of life at baseline and at 3, 6, and 12 months postintervention. Clinical data (i.e., HbA1c) were collected from childrens medical records preintervention and postintervention. Results:There were no significant treatment effects 12 months postintervention, but parents in both groups reported improved coping (p < .001), less responsibility for treatment management (p < .001), and improved quality of life (p = .005). While childrens metabolic control worsened over time, mean values at 12 months were still within the recommended levels in this well-controlled sample (HbA1c <8%). Discussion:Group-based interventions for parents of children with T1D may lessen the impact of treatment management, improving coping and quality of life.

An internet coping skills training program for youth with type 1 diabetes: six-month outcomes.

Background:Managing Type 1 diabetes (T1D) during adolescence can be challenging, and there is a need for accessible interventions to help adolescents cope with diabetes-related stress. Objectives:The aim of this study was to compare an Internet coping skills training (TEENCOPE) intervention to an Internet educational intervention (Managing Diabetes) for adolescents with T1D. Moderators of program efficacy were evaluated. Methods:The study was a multisite clinical trial (n = 320) with data collected at baseline, 3 months, and 6 months. Data were collected on the primary outcomes of physiologic (A1C) and psychosocial (quality of life) and on the secondary outcomes of behavioral (self-management) and psychosocial (stress, coping self-efficacy, social competence, family conflict) variables consistent with the conceptual framework. Data were analyzed using mixed-model analyses with an intent-to-treat approach. Results:There were no significant between-group treatment effects 6 months postintervention on primary outcomes. The Managing Diabetes youth showed a significant increase in social competence compared to the TEENCOPE youth. There were significant time effects for TEENCOPE (decreased stress and increased coping) and Managing Diabetes (improved diabetes quality of life). Discussion:Youth with T1D transitioning to adolescence may need both structured diabetes education and coping skills to improve health outcomes. There may be a higher potential to reach adolescents with Type 1 diabetes of varying race and ethnicity via Internet interventions.

Response analysis for multiple symptoms revealed differences between arms of a symptom management trial.

OBJECTIVE To describe the methodology of evaluating the response of cancer patients to interventions directed at lowering severity of multiple symptoms, and to compare two arms of a symptom management trial to determine factors associated with response and time to response. STUDY DESIGN AND SETTING Randomized trial comparing a nurse-assisted symptom management (NASM) cognitive-behavioral intervention with an automated telephone symptom management (ATSM). Patients in both arms received six intervention contacts over 8 weeks. Analyses of the intervention contact data for 190 patients in NASM arm and 164 patients in the ATSM arm were conducted. Severities of 15 cancer-related symptoms were assessed at each intervention contact, and an anchor-based definition of response was adopted. Analyses were carried out using generalized estimating equations and Cox marginal proportional hazard models. RESULTS When compared with patients in the NASM, patients in the ATSM had better response to manage anxiety, depression, poor appetite, cough, and fatigue. NASM was more successful in managing cancer pain. Response and time to response were associated with several patient and disease characteristics. CONCLUSION The approach described here presents an analytic and clinical improvement over methods that examine each symptom separately or use summed scores of severity.

Deconstruction of Nurse-Delivered Patient Self-Management Interventions for Symptom Management: Factors Related to Delivery Enactment and Response

This research examines the processes by which patient self-management interventions are related to symptom responses among cancer patients. A total of 333 patients from two randomized clinical trials were combined. Each patient received a six-contact 8-week patient self-management intervention delivered by a nurse to address symptoms. Nurses’ decisions to deliver the strategies, patient enactment of strategies, and their success were investigated using patient- and symptom-level characteristics. Generalized estimating equation modeling accounted for clustering of symptoms and strategies delivered for each symptom within patient. Patient self-management intervention strategies were classified into four classes. Strategies were delivered by nurses for symptoms with higher interference and longer duration. Patient and symptom factors were related to enactment strategies. Symptom responses were related to number of strategies tried by patients. Delivery and enactment of strategies were related to both patient and symptom characteristics.

Exploring the relationship between spiritual well-being and quality of life among patients newly diagnosed with advanced cancer

OBJECTIVE In our context, existential plight refers to heightened concerns about life and death when people are diagnosed with cancer. Although the duration of existential plight has been proposed to be approximately 100 days, evidence from longitudinal studies raises questions about whether the impact of a diagnosis of advanced cancer may require a longer period of adjustment. The purpose of our study was to examine spiritual well-being (SpWB) and quality of life (QoL) as well as their interrelationship in 52 patients with advanced cancer after 100 days since the diagnosis at one and three months post-baseline. METHOD The study was designed as a secondary data analysis of a cluster randomized clinical trial involving patients with stage 3 or 4 cancer undergoing treatment. SpWB was measured using the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12); common factor analyses revealed a three-factor pattern on the FACIT-Sp-12. Quality of life was measured with the Functional Assessment of Cancer Therapy-General (FACT-G). We limited our sample to participants assigned to the control condition (n = 52). RESULTS SpWB and QoL remained stable between one and three months post-baseline, which were a median of 112 and 183 days after diagnosis, respectively. SpWB was found to be associated with QoL more strongly than physical and emotional well-being. Peace and Meaning each contributed unique variance to QoL, and their relative importance shifted over time. Faith was positively related to QoL initially. This association became insignificant at three months post-baseline. SIGNIFICANCE OF RESULTS This study underscores the significance of SpWB for people newly diagnosed with advanced cancer, and it highlights the dynamic pattern of Peace, Meaning, and Faith in association with QoL. Our results confirm that patients newly diagnosed with advanced cancer experience an existential crisis, improve and stabilize over time. Future studies with larger samples over a longer period of time are needed to verify these results.

Differential symptom reporting by mode of administration of the assessment: automated voice response system versus a live telephone interview.

Background:Automated voice response (AVR) systems have been used to collect patient-reported outcome data. Mode of administration of the assessment may affect patient reporting. Objective:To evaluate if there is a differential reporting of symptoms by the mode of assessment: AVR versus a live telephone interview among cancer patients with solid tumors undergoing chemotherapy. Research Design:Randomized clinical trial comparing a nurse-assisted symptom management with an automated telephone symptom management. After completing intake telephone interview administered by a person, patients were randomized to either nurse arm or AVR arm to receive a 6-contact 8-week symptom management intervention. Patients in the nurse arm were called by specially trained nurses, and patients in the AVR arm were contacted via automated system to assess their symptoms and deliver symptom management strategies. Subjects:Two hundred patients in nurse arm, and 186 patients in the AVR arm completed the first intervention contact. Measures:Severities of 14 cancer-related symptoms were rated by patients at intake interview and at first intervention contact before the receipt of any interventions. Results:When compared with patients contacted by a nurse, patients contacted by the AVR reported higher severity of nausea and vomiting, diarrhea, poor appetite, constipation, diarrhea, pain, and alopecia controlling for prior intake symptom assessment that was free of mode effect. Symptom reporting varied by age, with the oldest group of patients reporting higher severity to the nurse. Conclusion:Mode effect needs to be considered in designing trials for symptom management and in symptom monitoring in clinical practice.

Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure.

BACKGROUND Chronic insomnia is common among patients with heart failure (HF) and may contribute to fatigue and poor function. However, to date there have been no randomized controlled trials focused on treatment of insomnia or daytime symptoms in this population. OBJECTIVES The purpose of this study was to examine the preliminary efficacy, feasibility, and acceptability of a self-management intervention (cognitive behavioral therapy [CBT-I]) for insomnia among patients with stable HF. METHODS We conducted a pilot randomized controlled trial (RCT) in which patients with stable Class I-III HF (n = 25/52.1% women; mean age = 59 ± 14.8 years) were randomized in groups to CBT-I (n = 29) or an attention control condition (HF self-management with sleep hygiene; n = 19). Participants completed 2 weeks of wrist actigraphy, the insomnia severity index, and measures of fatigue, depression, sleepiness, and functional performance at baseline and follow-up. We computed the size of the effects on the dependent variables and used MANOVA to evaluate the effects of CBT-I on insomnia and fatigue. RESULTS CBT-I was feasible and acceptable and had a statistically significant effect on insomnia and fatigue, while controlling for the effects of comorbidity and age. CONCLUSIONS CBT-I has short-term efficacy as a treatment for chronic insomnia among patients with stable HF. Future studies are needed to address its sustained effects.