Cancer-related fatigue: benefits of information booklets to improve patients' knowledge and empowerment.

PURPOSE: To investigate cancer patients' knowledge and attitudes regarding fatigue and the potential benefits and acceptability of a brief information booklet. METHODS: The CARPE DIEM study assessed knowledge and attitudes regarding fatigue in a diverse group of 50 cancer patients before (T0) and about one (T1) and four months (T2) after reading the booklet. At T1, participants additionally rated its usefulness. RESULTS: At baseline, 37.5% of respondents did not know the term "fatigue" or what it meant. Those who already knew something about fatigue mainly had obtained their information from booklets, books, or articles (63.3%) and/or the internet (46.7%). Overall, knowledge gaps existed, particularly about potential fatigue treatment options and whether fatigue is an indicator of cancer progression. Furthermore, 56.4% felt poorly informed, and 46.1% reported feeling helpless in the face of fatigue. Lower knowledge at baseline was significantly associated with lower education and older age. At T1 and T2, there were significant improvements in several knowledge questions and attitudes. Patient-reported benefits included getting new information about fatigue (91.1%), awareness of not being alone with their problems (89.7%), taking appropriate actions (72.9%), and encouragement to talk about their fatigue with family/friends (55.3%) or with a health professional (52.7%). CONCLUSIONS: Specific gaps were identified in the provision of information and education for cancer patients about fatigue. A low-cost intervention asking to read a brief information booklet was associated with improved knowledge. This could be considered as a first step offered as part of a bundle of further efforts to improve knowledge and care of fatigue.

Suicidal ideation in patients with cancer: Its prevalence and results of structural equation modelling.

OBJECTIVE: Patients with cancer have a higher risk of suicidal ideation (SI) and suicidality than the general population. This study was designed to investigate the prevalence of SI and its association with psychosocial and sociodemographic factors and tumour entity. METHODS: In this observational cross-sectional study, 4372 adult patients with different cancer entities were enrolled. We assessed the outcome variables (i.e. SI, depressive and anxiety symptoms, mental and physical fatigue and sociodemographic data) using self-report questionnaires. Data were analysed via descriptive statistics, binomial logistic regression and structural equation modelling (SEM). RESULTS: Among all patients, 627 (14.3%) reported SI, of whom 12.8% reported SI on several days, 0.9% on half of the days and 0.6% nearly every day. Age, anxiety, mental fatigue and the Patient Health Questionnaire-9 items 'feeling down, depressed and hopeless', 'feeling bad about oneself' and 'slowing or agitation' were significant predictors of SI. SEM, including all significant predictors with a latent depressiveness-demoralisation variable, explained 30.3% variance of SI, showing a good fit. CONCLUSIONS: Our results showed that a significant number of patients with cancer show SI. Future long-term studies are needed to address the differential contribution of depression and demoralisation on SI in patients with cancer.

Acceptability and Feasibility of a Guided Biopsychosocial Online Intervention for Cancer Patients Undergoing Chemotherapy.

Chemotherapy is a physically and psychologically highly demanding treatment, and specific Internet-based interventions for cancer patients addressing both physical side effects and emotional distress during chemotherapy are scarce. This study examined the feasibility and acceptability of a guided biopsychosocial online intervention for cancer patients undergoing chemotherapy (OPaCT). A pre-post, within-participant comparison, mixed-methods research design was followed. Patients starting chemotherapy at the outpatient clinic of the National Center for Tumor Diseases in Heidelberg, Germany, were enrolled. Feasibility and acceptability were evaluated through intervention uptake, attrition, adherence and participant satisfaction. As secondary outcomes, PHQ-9, GAD-7, SCNS-SF34-G and CBI-B-D were administered. A total of N = 46 patients participated in the study (female 76.1%). The age of participants ranged from 29 to 70 years (M = 49.3, SD = 11.3). The most prevalent tumour diseases were breast (45.7%), pancreatic (19.6%), ovarian (13.1%) and prostate cancer (10.8%). A total of N = 37 patients (80.4%) completed the OPaCT intervention. Qualitative and quantitative data showed a high degree of participant satisfaction. Significant improvements in the SCNS-SF34 subscale 'psychological needs' were found. Study results demonstrate the feasibility and acceptability of the intervention. The results show that OPaCT can be implemented well, both in the treatment process and in participants' everyday lives. Although it is premature to make any determination regarding the efficacy of the intervention tested in this feasibility study, these results suggest that OPaCT has the potential to reduce unmet psychological care needs of patients undergoing chemotherapy.

Heidelberg Neuro-Music Therapy for chronic-tonal tinnitus - treatment outline and psychometric evaluation.

INTRODUCTION: Musical training positively influences the cortical plasticity of the brain and has proven to be effective in treating chronic tinnitus. OBJECTIVES: A neuro-music therapy concept, the "Heidelberg Neuro-Music Therapy" treatment was developed and evaluated. DESIGN: A prospective, cross-sectional design was used. MATERIALS AND METHODS: N = 135 patients (mean age 47 years) with chronic, tonal tinnitus attended a standardized protocol for Neuro-Music Therapy (either "standard therapy" ST or "compact therapy" CT). The results were compared to a cognitive behavioral placebo music therapy procedure (PT). Tinnitus distress was assessed using the German version of the Tinnitus-Questionnaire (TQ) at admission, at discharge and six months after therapy. Changes were assessed statistically and by means of clinical significance. RESULTS: TQ scores significantly improved - independent of group allocation. But more than 80% of the music therapy patients (both ST and CT) revealed a reliable improvement ("responder") compared to 44% in the PT group. Therapy impact seems to be lasting since TQ scores remained stable until follow-up at six months. CONCLUSIONS: The "Heidelberg Neuro-Music Therapy" is a method with fast onset and long lasting effect for patients with "tonal" tinnitus. A number of potential working factors accounting for the treatment success are highlighted.

Feasibility study of a self-guided internet-based intervention for family caregivers of patients with cancer (OAse).

Despite high levels of distress, family caregivers of patients with cancer rarely seek psychosocial support and Internet-based interventions (IBIs) are a promising approach to reduce some access barriers. Therefore, we developed a self-guided IBI for family caregivers of patients with cancer (OAse), which, in addition to patients' spouses, also addresses other family members (e.g., adult children, parents). This study aimed to determine the feasibility of OAse (recruitment, dropout, adherence, participant satisfaction). Secondary outcomes were caregivers' self-efficacy, emotional state, and supportive care needs. N = 41 family caregivers participated in the study (female: 65%), mostly spouses (71%), followed by children (20%), parents (7%), and friends (2%). Recruitment (47%), retention (68%), and adherence rates (76% completed at least 4 of 6 lessons) support the feasibility of OAse. Overall, the results showed a high degree of overall participant satisfaction (96%). There were no significant pre-post differences in secondary outcome criteria, but a trend toward improvement in managing difficult interactions/emotions (p = .06) and depression/anxiety (p = .06). Although the efficacy of the intervention remains to be investigated, our results suggest that OAse can be well implemented in caregivers' daily lives and has the potential to improve family caregivers' coping strategies.

Patient expectations are better for immunotherapy than traditional chemotherapy for cancer.

PURPOSE: The main aim of the study was to explore the expectations and knowledge of advanced-stage cancer patients about immunotherapy. METHODS: This mixed methods study included 53 cancer patients on immune checkpoint inhibitors (ICIs), 55 cancer patients undergoing chemotherapy (CT), and 53 non-cancer patients. Participants' expectations about ICIs and CT were compared. Additional qualitative data were derived from semi-structured interviews. RESULTS: Among patients who did not receive ICIs, 63 (58%) had never heard of ICIs and 94 (87%) had large gaps in their knowledge of ICIs. Among ICI patients, 33 (62%) simply described ICIs without errors. ICI perception was positive, regardless of whether respondents received or had heard of ICIs, which became particularly evident when compared to CT. ICIs were rated as more promising, and all adverse effects were expected to be significantly lower than those of CT. Knowledge about ICIs was also limited in the interviewed ICI patients. Some patients reported adverse effects of ICIs that were mostly mild and well-tolerated or easily treated. CONCLUSIONS: The lack of understanding of ICIs should be improved by activities to increase the knowledge of ICI patients and the general population. In contrast to CT, ICIs invoked fewer negative associations with efficacy and toxicity. Therefore, attention should be paid to risk awareness when educating patients. (Clinical trial registration number: DRKS00011868) Trial Registration: German clinical trials register, www.germanctr.de , number DRKS00011868.

Screening for depression in cancer patients using the PHQ-9: The accuracy of somatic compared to non-somatic items.

BACKGROUND: The PHQ-9 is a standard screening tool for depressive disorders in cancer patients. As for the frequently reported symptom overlap with somatic disease, it has been debated whether somatic items are suitable for identifying depressive disorders in cancer patients. Thus, this study examines the diagnostic accuracy of somatic versus cognitive-emotional PHQ-9 items. METHODS: The routine data of 4,705 patients, screened at the National Center for Tumor Diseases in Heidelberg between 2011 and 2016, was analyzed. For the single PHQ-9 items, receiver operating characteristics (ROC), sensitivity, specificity, positive, and negative predictive values (PPV and NPV), the Youden Index (YI), and the Clinical Utility Index (UI+/UI-) were applied for the diagnoses of major depressive disorder (MDD) and any depressive disorder (ADD). RESULTS: The non-somatic items played a pivotal role in the diagnosis of MDD, whereas the diagnostic accuracy of the somatic items increased in the diagnosis of ADD. For both MDD and ADD, the best performance was achieved by the non-somatic items "little interest" and "feeling down." LIMITATIONS: In this study, only one self-reported instrument was used (i.e., the PHQ-9). In other words, the diagnoses were not validated by clinical interviews or other self-reported instruments. CONCLUSION: The somatic PHQ-9 items showed less discriminatory value than the non-somatic items. However, they may be useful as screening mechanisms for identifying at-risk cancer patients with mild/moderate depression. Disregarding the somatic items would lead to an underestimation of depressive syndromes and inadequate treatment of somatic symptoms.

Heidelberg Neuro-Music Therapy Restores Attention-Related Activity in the Angular Gyrus in Chronic Tinnitus Patients.

Background: Tinnitus is the perception of a phantom sound without external acoustic stimulation. Recent tinnitus research suggests a relationship between attention processes and tinnitus-related distress. It has been found that too much focus on tinnitus comes at the expense of the visual domain. The angular gyrus (AG) seems to play a crucial role in switching attention to the most salient stimulus. This study aims to evaluate the involvement of the AG during visual attention tasks in tinnitus sufferers treated with Heidelberg Neuro-Music Therapy (HNMT), an intervention that has been shown to reduce tinnitus-related distress. Methods: Thirty-three patients with chronic tinnitus, 45 patients with recent-onset tinnitus, and 35 healthy controls were tested. A fraction of these (21/21/22) were treated with the "compact" version of the HNMT lasting 1 week with intense treatments, while non-treated participants were included as passive controls. Visual attention was evaluated during functional Magnet-Resonance Imaging (fMRI) by a visual Continous Performance Task (CPT) using letter-based alarm cues ("O" and "X") appearing in a sequence of neutral letters, "A" through "H." Participants were instructed to respond via button press only if the letter "O" was followed by the letter "X" (GO condition), but not to respond if a neutral letter appeared instead (NOGO condition). All participants underwent two fMRI sessions, before and after a 1-week study period. Results: The CPT results revealed a relationship between error rates and tinnitus duration at baseline whereby the occurrence of erroneous "GO omissions" and the reaction time increased with tinnitus duration. Patients with chronic tinnitus who were treated with HNMT had decreasing error rates (fewer GO omissions) compared to treated recent-onset patients. fMRI analyses confirmed greater activation of the AG during CPT in chronic patients after HNMT treatment compared to treated recent-onset patients. Conclusions: Our findings suggest that HNMT treatment helps shift the attention from the auditory phantom percept toward visual cues in chronic tinnitus patients and that this shift in attention may involve the AG.

Heidelberg Neuro-Music Therapy Enhances Task-Negative Activity in Tinnitus Patients.

Background: Suffering from tinnitus causes mental distress in most patients. Recent findings point toward a diminished activity of the brain's default-mode network (DMN) in subjects with mental disorders including depression or anxiety and also recently in subjects with tinnitus-related distress. We recently developed a therapeutic intervention, namely the Heidelberg Neuro-Music Therapy (HNMT), which shows an effective reduction of tinnitus-related distress following a 1-week short-term treatment. This approach offers the possibility to evaluate the neural changes associated with the improvements in tinnitus distress. We previously reported gray matter (GM) reorganization in DMN regions and in primary auditory areas following HNMT in cases of recent-onset tinnitus. Here we evaluate on the same patient group, using functional MRI (fMRI), the activity of the DMN following the improvements tinnitus-related distress related to the HNMT intervention. Methods: The DMN activity was estimated by the task-negative activation (TNA) during long inter-trial intervals in a word recognition task. The level of TNA was evaluated twice, before and after the 1-week study period, in 18 treated tinnitus patients ("treatment group," TG), 21 passive tinnitus controls (PTC), and 22 active healthy controls (AC). During the study, the participants in TG and AC groups were treated with HNMT, whereas PTC patients did not receive any tinnitus-specific treatment. Therapy-related effects on DMN activity were assessed by comparing the pairs of fMRI records from the TG and PTC groups. Results: Treatment of the TG group with HNMT resulted in an augmented DMN activity in the PCC by 2.5% whereas no change was found in AC and PTC groups. This enhancement of PCC activity correlated with a reduction in tinnitus distress (Spearman Rho: -0.5; p < 0.005). Conclusion: Our findings show that an increased DMN activity, especially in the PCC, underlies the improvements in tinnitus-related distress triggered by HNMT and identify the DMN as an important network involved in therapeutic improvements.

Cortical reorganization in recent-onset tinnitus patients by the Heidelberg Model of Music Therapy.

Pathophysiology and treatment of tinnitus still are fields of intensive research. The neuroscientifically motivated Heidelberg Model of Music Therapy, previously developed by the German Center for Music Therapy Research, Heidelberg, Germany, was applied to explore its effects on individual distress and on brain structures. This therapy is a compact and fast application of nine consecutive 50-min sessions of individualized therapy implemented over 1 week. Clinical improvement and long-term effects over several years have previously been published. However, the underlying neural basis of the therapy's success has not yet been explored. In the current study, the therapy was applied to acute tinnitus patients (TG) and healthy active controls (AC). Non-treated patients were also included as passive controls (PTC). As predicted, the therapeutic intervention led to a significant decrease of tinnitus-related distress in TG compared to PTC. Before and after the study week, high-resolution MRT scans were obtained for each subject. Assessment by repeated measures design for several groups (Two-Way ANOVA) revealed structural gray matter (GM) increase in TG compared to PTC, comprising clusters in precuneus, medial superior frontal areas, and in the auditory cortex. This pattern was further applied as mask for general GM changes as induced by the therapy week. The therapy-like procedure in AC also elicited similar GM increases in precuneus and frontal regions. Comparison between structural effects in TG vs. AC was calculated within the mask for general GM changes to obtain specific effects in tinnitus patients, yielding GM increase in right Heschl's gyrus, right Rolandic operculum, and medial superior frontal regions. In line with recent findings on the crucial role of the auditory cortex in maintaining tinnitus-related distress, a causative relation between the therapy-related GM alterations in auditory areas and the long-lasting therapy effects can be assumed.

The effectiveness of neuro-music therapy according to the Heidelberg model compared to a single session of educational counseling as treatment for tinnitus: a controlled trial.

OBJECTIVES: Tinnitus is a very common symptom, yet the quest for an effective treatment is challenging. Results from several clinical trials support the notion that neuro-music therapy is an effective means to reduce tinnitus distress with short duration and long lasting effect. However, until now, the effectiveness has not been tested in a controlled trial against an active comparator. METHODS: The trial was designed as two-center, parallel intervention group controlled study with two intervention groups: Counseling (50minute individualized personal instruction) or neuro-music therapy (counseling plus eight 50-minute sessions of individualized music therapy). Data of n=290 patients suffering from chronic tinnitus were analyzed. Outcome measure was the change in Tinnitus Questionnaire Total Scores (TQ) from baseline (admission) to end of treatment. RESULTS: Both treatment groups achieved a statistically relevant reduction in TQ scores, though 66% of patients in the music therapy group attained a clinically meaningful improvement compared to 33% in the counseling group. A binary logistic regression revealed two variables significantly influencing therapy outcome: initial tinnitus score and type of therapy with an OR for the music therapy compared to the counseling of 4.34 (CI 2.33-8.09). CONCLUSIONS: Counseling is an appropriate treatment option with well above chance of improvement. The neuro-music therapy outperformed the counseling. This treatment targets the tinnitus sound itself, is short in duration, intrinsically motivating and easy to operate and thus presents a possible complement to the therapeutic spectrum in chronic tinnitus. The trial was registered at the ClinicalTrials.gov registry (ID: NCT01845155).

Music therapy for chronic tinnitus: variability of tinnitus pitch in the course of therapy.

BACKGROUND: In general, tinnitus pitch has been observed to be variable across time for most patients experiencing tinnitus. Some tinnitus therapies relate to the dominant tinnitus pitch in order to adjust therapeutic interventions. As studies focusing on tinnitus pitch rarely conduct consecutive pitch matching in therapeutic settings, little is known about the course and variability of tinnitus pitch during therapeutic interventions. PURPOSE: The purpose of this study was to investigate the variability and development of tinnitus pitch in the course of therapeutic interventions. Tinnitus pitch was suspected to be highly variable. RESEARCH DESIGN: The researchers conducted a descriptive, retrospective analysis of data. STUDY SAMPLE: A total of 175 adult patients experiencing chronic tinnitus served as participants. All patients had received a neuro-music therapy according to the "Heidelberg Model of Music Therapy for Chronic Tinnitus." DATA COLLECTION AND ANALYSIS: During therapeutic interventions lasting for 5 consecutive days, the individual tinnitus frequency was assessed daily by means of a tinnitus pitch-matching procedure. The extent of variability in tinnitus pitch was calculated by mean ratios of frequencies between subsequent tinnitus measurements. Analysis of variance of repeated measures and post hoc paired samples t-tests were used for comparison of means in tinnitus frequencies, and the test-retest reliability of measurements was obtained by the Pearson product-moment correlation coefficient. RESULTS: Tinnitus pitch displayed a variability of approximately 3/5 to 4/5 octaves per day. Overall, the mean frequency declined in the course of the therapy. Detailed analysis revealed three groups of patients with diverging tinnitus progression. The test-retest reliability between assessments turned out to be robust (r = 0.74 or higher). CONCLUSIONS: Considerable variation in tinnitus pitch was found. Consequently, a frequent rechecking of tinnitus frequency is suggested during frequency-specific acoustic stimulation in order to train appropriate frequency bands.

Music therapy as an early intervention to prevent chronification of tinnitus.

In the present study a music therapeutic intervention according to the 'Heidelberg Model' was evaluated as a complementary treatment option for patients with acute tinnitus whom medical treatment only brought minimal or no improvement. The central question was if music therapy in an early phase of tinnitus was able to reduce tinnitus symptoms and to prevent them from becoming chronical. 23 patients with acute tinnitus (6-12 weeks) were included in this study and took part in our manualized short term music therapeutic treatment which lasted ten consecutive 50-minutes sessions of individualized therapy. Tinnitus severity and individual tinnitus related distress were assessed by the Tinnitus Beeinträchtigungs-Fragebogen (i.e. Tinnitus Impairment Questionnaire, TBF-12) at baseline, start of treatment, and end of treatment. Score changes in TBF-12 from start to end of the treatment showed significant improvements in tinnitus impairment. This indicates that this music therapy approach applied in an initial stage of tinnitus can make an important contribution towards preventing tinnitus from becoming a chronic condition.

Long-term effects of the "Heidelberg Model of Music Therapy" in patients with chronic tinnitus.

OBJECTIVE: The "Heidelberg Model of Music Therapy for Chronic Tinnitus" is a manualized short term treatment (nine 50-minutes sessions of individualized therapy on five consecutive days). It has proven to be efficient in reducing tinnitus symptoms in the short run. Now the long-term impact of the treatment after up to 5.4 years should be explored. MATERIALS AND METHODS: 206 patients who had attended the neuro-music therapy were addressed in a structured follow-up questionnaire survey. 107 complete questionnaires entered analysis. Follow-up time was 2.65 (SD 1.1) years. RESULTS: 76% of the patients achieved a reliable reduction in their tinnitus scores, the overall tinnitus distress as measured by the Mini-TQ diminished from 11.9 (SD = 4.9) to 7.4 (SD = 5.2) points, 87% of the patients were satisfied by the way they were treated during therapy, and 71% of the patients did not undergo any further treatment after. Evaluation of therapeutic elements displays, that only music therapy specific interventions were rated helpful by the patients. Tinnitus related factors (such as tinnitus pitch or loudness, time since onset) did not influence therapy outcome but female gender, positive therapeutic relationship, and higher initial Mini-TQ scores became apparent as factors predicting better chances for greater therapy success. DISCUSSION: The "Heidelberg Model of Music Therapy for Chronic Tinnitus" seems to be effective in the long run. The outcome effect size of d' = 0.89, can be accounted for as "large" effect and falls into the upper range value compared to established treatments.