Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial

Abstract Background Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. Methods Family-SCOUT is a project supported by the German Innovation Fund (https://innovationsfonds.g-ba.de/). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. Discussion The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. Trial registration ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.

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Comprehensive support for families with parental cancer – Family-SCOUT: study protocol for the evaluation of a complex intervention

10.21203/rs.3.rs-401056/v1 ◽

2021 ◽

Author(s):

Marc Dohmen ◽

Andrea Petermann-Meyer ◽

Daniel Blei ◽

Rebecca Bremen ◽

Evamarie Brock-Midding ◽

...

Keyword(s):

Health Insurance ◽

Minimal Important Difference ◽

Depression Scale ◽

Control Group ◽

Parental Cancer ◽

Primary Analysis ◽

Insurance Funds ◽

Health Insurance Funds ◽

And Control

Abstract Background: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information and care on an emotional, psycho-social and communicative level during and after the cancer experience and across healthcare sectors.Methods: Family-SCOUT is a project supported by the German Innovation Fund (https://innovationsfonds.g-ba.de/). The evaluation is based on a mixed method quasi-experimental design with intervention and control group. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months follow-up; T2: 9 months follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. Study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. Discussion: Results will allow to test the effectiveness and efficiency of the intervention for the target group. First experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as basis to assess the need of including the intervention in the catalogue of services of the statutory health insurance funds in Germany. Trial registration: ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.

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Mamma Mia – A randomized controlled trial of an internet-based intervention for perinatal depression

Psychological Medicine ◽

10.1017/s0033291718002544 ◽

2018 ◽

Vol 49 (11) ◽

pp. 1850-1858 ◽

Cited By ~ 11

Author(s):

Silje Marie Haga ◽

Filip Drozd ◽

Carina Lisøy ◽

Tore Wentzel-Larsen ◽

Kari Slinning

Keyword(s):

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Control Group ◽

Group Data ◽

Perinatal Depressive Symptoms ◽

Group 2 ◽

And Control

AbstractBackgroundStudies suggest that 10–15% of perinatal women experience depressive symptoms. Due to the risks, problems with detection, and barriers to treatment, effective universal preventive interventions are needed. The aim of this study was to assess the effectiveness of an automated internet intervention (‘Mamma Mia’) on perinatal depressive symptoms. Mamma Mia is tailored specifically to the perinatal phase and targets risk and protective factors for perinatal depressive symptoms.MethodsA total of 1342 pregnant women were randomized to an intervention (‘Mamma Mia’) and control group. Data were collected at gestational week (gw) 21–25, gw37, 6 weeks after birth, and 3 and 6 months after birth. We investigated whether (1) the intervention group displayed lower levels of depressive symptoms compared with the control group, (2) the effect of Mamma Mia changed over time, (3) the effect on depressive symptoms was moderated by baseline depressive symptoms, previous depression, and parity, and (4) this moderation changed by time. Finally, we examined if the prevalence of mothers with possible depression [i.e. Edinburgh Postnatal Depression Scale (EPDS)-score ⩾10] differed between the intervention and control group.ResultsParticipants in the Mamma Mia group displayed less depressive symptoms than participants in the control group during follow-up [F(1) = 7.03, p = 0.008]. There were indications that the effect of Mamma Mia was moderated by EPDS score at baseline. The prevalence of women with EPDS-score ⩾10 was lower in the Mamma Mia group at all follow-up measurements.ConclusionsThe study demonstrated the effects of the automated web-based universal intervention Mamma Mia on perinatal depressive symptoms.

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Longitudinal measurement invariance of the patient health questionnaire in a German sample

BMC Psychiatry ◽

10.1186/s12888-021-03390-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anne Moehring ◽

Diana Guertler ◽

Kristian Krause ◽

Gallus Bischof ◽

Hans-Juergen Rumpf ◽

...

Keyword(s):

Factor Structure ◽

Trial Registration ◽

Patient Health Questionnaire ◽

Control Group ◽

Health Questionnaire ◽

Baseline Assessment ◽

Link Type ◽

Patient Health ◽

And Control

Abstract Background The Patient Health Questionnaire-8 (PHQ-8) is a screening questionnaire of depressive symptoms. However, it is unknown whether it is equivalent across time and between groups of individuals. The aim of our paper was to test whether the PHQ-8 has the same meaning in two groups of individuals over time. Methods Primary care patients were proactively recruited from three German cities. PHQ-8 data from a baseline assessment (n = 588), two assessments during the intervention (n = 246/225), and a six (n = 437) and 12 months (n = 447) follow-up assessment were first used to examine the factor structure of the PHQ-8 by confirmatory factor analysis (CFA). The best fitting factor solution was then used to test longitudinal invariance across time and between intervention and control group by Multiple Group CFA. Results A two-factor structure consistently showed the best model fit. Only configural longitudinal invariance was evidenced when the baseline assessment was included in the analysis. Without the baseline assessment, strict longitudinal invariance was shown across the intervention and the follow-up assessments. Scalar invariance was established between the intervention and control group for the baseline assessment and strict invariance between groups and across the 6- and 12-month follow-up assessments. Conclusions The lack of longitudinal invariance might be attributed to various differences between the baseline assessments and all following assessments, e.g., assessment mode (iPad vs telephone), potential changes in symptom perception, and setting. Trial registration DRKS00011635, date of trial registration: 20.01.2017; DRKS00011637, date of trial registration: 25.01.2017.

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Impact of type 2 diabetes on the association between neurodegenerative diseases and cancer in elderly Koreans: a 10-year retrospective cohort study using the National Health Insurance Service Database

10.21203/rs.3.rs-844820/v1 ◽

2021 ◽

Author(s):

Hee-Cheol Kim ◽

Ji-Hun Kim ◽

Ho-Jun Lee ◽

Yang-Tae Kim ◽

Byeong-Churl Jang

Keyword(s):

Type 2 Diabetes ◽

Health Insurance ◽

National Health Insurance ◽

Cancer Incidence ◽

Control Group ◽

Newly Diagnosed ◽

Control Groups ◽

And Control

Abstract Background Some studies suggest that cancer and type 2 diabetes (T2D), as well as neurodegenerative disease (ND), are related to protein misfolding and possibly to each other. This study aimed to investigate the association between NDs and cancer to evaluate the impact of T2D on the association between NDs and cancer. Methods A population-based 10-year follow-up study was conducted using the Korean National Health Insurance Service Database between 2002 and 2015. The study population included an ND group (n = 9,292) and control group (n = 46,742), aged ≥ 60 years. A multivariable Cox proportional hazards regression model was used to evaluate the hazard ratio (HR) and 95% confidence interval (CI) for cancer risk. Results Various NDs and/or T2D were newly diagnosed in ND and control groups during the 10-year follow-up periods. Newly developed ND cases before cancer onset were 2,412 (26.0%) in the ND group and 15,435 (33.0%) in the control group (χ2 = 178.19, p < 0.01). Newly developed T2D cases before cancer onset were 4,691 (50.5%) and 25,695 (55.0%) in the ND and control groups, respectively (χ2 = 62.89, p < 0.01). As of December 31, 2015 (the end of the observation period), the number of cancer patients in the ND group was 2,040 (22.0%) and that in the control group was 8,628 (18.5%) (χ2 = 61.45, p < 0.01). The ND group was associated with an increased risk of cancer (HR, 1.25; 95% CI, 1.19–1.31). In both groups, newly diagnosed ND and T2D patients showed an additive effect on cancer incidence during the follow-up period. The additional effect on cancer incidence was higher in T2D than in ND. Conclusion This study showed a positive association between NDs and cancer, and an additive effect of T2D on this association. Further replication studies are needed to address the association among NDs, cancer, and T2D.

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Impact of Type 2 Diabetes on the Association Between Neurodegenerative Diseases and Cancer in Elderly Koreans: A 10-year Retrospective Cohort Study Using the National Health Insurance Service Database

10.21203/rs.3.rs-844820/v2 ◽

2021 ◽

Author(s):

Hee-Cheol Kim ◽

Ji-Hun Kim ◽

Ho-Jun Lee ◽

Yang-Tae Kim ◽

Byeong-Churl Jang

Keyword(s):

Type 2 Diabetes ◽

Health Insurance ◽

National Health Insurance ◽

Additive Effect ◽

Control Group ◽

Newly Diagnosed ◽

Control Groups ◽

And Control

Abstract BackgroundSome studies suggest that cancer and type 2 diabetes (T2D), as well as neurodegenerative diseases (NDs), are related to protein misfolding and possibly to each other. This study aimed to investigate the association between NDs and cancer, and to determine the impact of T2D on the association between NDs and cancer.MethodsA population-based 10-year follow-up study was conducted using the Korean National Health Insurance Service Database between 2002 and 2015. The study population included an ND group (n = 9,292) and control group (n = 46,742), aged ≥60 years. A multivariable Cox proportional hazards regression model was used to evaluate the hazard ratio (HR) and 95% confidence interval (CI) for cancer risk.ResultsVarious another NDs and/or T2D were newly diagnosed in ND and control groups during the 10-year follow-up periods. Newly developed another ND cases before cancer onset were 2,412 (26.0%) in the ND group and 15,435 (33.0%) in the control group (χ2 = 178.19, p < 0.01). Newly developed T2D cases before cancer onset were 4,691 (50.5%) and 25,695 (55.0%) in the ND and control groups, respectively (χ2 = 62.89, p < 0.01). As of December 31, 2015 (the end of the observation period), the number of cancer patients in the ND group was 2,040 (22.0%) and that in the control group was 8,628 (18.5%) (χ2 = 61.45, p < 0.01). The ND group was associated with an increased risk of cancer (HR, 1.25; 95% CI, 1.19–1.31). In both groups, newly diagnosed another NDs and T2D showed an additive effect on cancer incidence during the follow-up period. The additive effect on cancer incidence was higher in T2D than in ND.ConclusionThis study showed a positive association between NDs and cancer, and an additive effect of T2D on this association. Further replication studies are needed to address the association among NDs, cancer, and T2D.

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Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00788-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Laura Williams ◽

Charlotte L. Hall ◽

Sue Brown ◽

Boliang Guo ◽

Marilyn James ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Medication Management ◽

Control Group ◽

Global Functioning ◽

Children And Young People ◽

Link Type ◽

Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

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Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receiving Bad News: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2013.51.2756 ◽

2014 ◽

Vol 32 (20) ◽

pp. 2166-2172 ◽

Cited By ~ 91

Author(s):

Maiko Fujimori ◽

Yuki Shirai ◽

Mariko Asai ◽

Kaoru Kubota ◽

Noriyuki Katsumata ◽

...

Keyword(s):

Communication Skills ◽

Patient Preferences ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Skills Training ◽

Control Group ◽

Communication Skills Training ◽

Communication Performance

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Charter of the Kazan Society of Physicians for the provision of medical care to participants in the sickness funds established by law on June 3, 1912

Kazan medical journal ◽

10.17816/kazmj48887 ◽

1913 ◽

Vol 13 (2) ◽

pp. 91-110

Keyword(s):

Health Insurance ◽

Medical Care ◽

Insurance Fund ◽

Health Insurance Fund ◽

Medical Assistance ◽

Medical Aid ◽

Insurance Funds ◽

The Law ◽

Health Insurance Funds ◽

The City

The Kazan Society of Physicians for the Provision of Medical Aid to the Participants of the Health Insurance Funds Established on the Basis of the Law of June 23, 1912 "has the goal of providing medical assistance to the participants of the Health Insurance Fund established on the basis of the Law of June 23, 1912 in the city of Kazan and its environs.

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Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽

10.1161/circ.125.suppl_10.ap186 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jaime Céspedes ◽

German Briceño ◽

Michael Farkouh ◽

Rajesh Vedanthan ◽

Martha Leal ◽

...

Keyword(s):

Educational Intervention ◽

Cardiovascular Health ◽

Controlled Trial ◽

Intervention Group ◽

Educational Programs ◽

Control Group ◽

Active Lifestyle ◽

And Control ◽

The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

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