Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research

Background: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. Objective: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). Methods: This paper is based on group and expert discussions, and focuses on the researchers’ perspectives after four RCTson mHealth interventions for chronic pain. Results: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. Conclusions: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention

Effects of blended learning training for oncology physicians to advise their patients about complementary and integrative therapies: results from the multicenter cluster-randomized KOKON-KTO trial

Background: Many oncology physicians are confronted with the topic of complementary and integrative medicine (CIM) by cancer patients. This study examined whether a blended learning (e-learning and a workshop) to train oncology physicians in providing advice on CIM therapies to their cancer patients, in addition to distributing an information leaflet about reputable CIM websites, had different effects on physician-reported outcomes in regard to consultations compared with only distributing the leaflet. Methods: In a multicenter, cluster-randomized trial, 48 oncology physicians were randomly allocated to an intervention group (CIM consultation and an information leaflet) or a control group (information leaflet only). After the training, the oncology physicians conducted 297 consultations with their cancer patients. Measurements were assessed at oncology physician, physician-patient-interaction (measured by external reviewers), and patient levels. This analysis focused on the physician outcomes of stress reaction and perceived consultation skill competency. In addition, qualitative interviews were conducted with a subsample of oncology physicians who experienced both, the intervention and control condition. Results: The oncology physicians in the intervention group showed a lower stress reaction in all measured dimensions after CIM consultations than those in the control group. There was no significant difference between oncology physicians in the intervention and control groups regarding the perceived consultation skill competency (overburden: intervention 1.4 [95% CI: 0.7;2.1]; control 2.1 [95% CI: 1.4;2.7], tension: 1.3 [95% CI: 0.7;2.0] vs. 1.9 [95% CI: 1.3;2.5], and discomfort with consultation situations: 1.0 [95% CI: 0.4;1.7]; vs. 1.7 [95% CI: 1.2;2.3]). The qualitative data showed that only providing the leaflet seemed impersonal to oncology physicians, while the training made them feel well prepared to conduct a full conversation about CIM and provide the information leaflet. Conclusions: In our exploratory study providing structured CIM consultations showed positive effects on the perceived stress of oncology physicians, and the training was subjectively experienced as an approach that improved physician preparation for advising cancer patients about CIM, however no effects regarding perceived consultation skill competency were found

Effects of training oncology physicians advising patients on complementary and integrative therapies on patient‐reported outcomes: A multicenter, cluster‐randomized trial

Background: Many patients with cancer do not disclose complementary medicine use but want their physician's advice on this matter. This study evaluated whether using blended learning (e-learning plus a workshop) to train oncology physicians in providing advice on complementary and integrative medicine (CIM) therapies to their patients with cancer, in addition to distributing an information leaflet on reputable CIM websites, had different effects on patient-reported outcomes for the consultation than only distributing the leaflet. Methods: In this multicenter, cluster-randomized trial, patients from private practices/hospital departments, recruited by 48 oncology physicians randomly allocated to an intervention group (CIM consultation plus information leaflet) or a control group (information leaflet), received CIM information. Patient-reported outcomes included satisfaction (Patient Satisfaction With Information on Cancer Treatment), readiness to make a decision (Preparation for Decision Making), and physician-patient communication (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and Communication 26 [EORTC QLQ-COMU26]) for the consultation. Qualitative interviews were conducted with a physician subsample. Results: A total of 291 patients (128 in the intervention group and 169 in the control group) advised by 41 physicians participated. Patients in the intervention group rated physician-patient communication higher on all EORTC QLQ-COMU26 scales (mean total score, 84.3 [95% CI, 79.5-89.2] vs 73.6 [95% CI, 69.3-78.0]; P = .002), were more satisfied with the advice (mean, 4.2 [95% CI, 4.0-4.4] vs 3.7 [95% CI, 3.5-3.8]; P < .001), and were readier to make a decision (mean, 63.5 [95% CI, 57.4-69.6] vs 53.2 [95% CI, 47.8-58.7]; P = .016) than the control group. Physicians who reported patients in both settings seemed satisfied with the advice given. Conclusions: This study evaluated a novel education intervention for training oncology physicians in providing CIM advice in routine care. Providing structured CIM consultations had positive effects on patient satisfaction, readiness to make decisions, and physician-patient communication

Training oncology physicians to advise their patients on complementary and integrative medicine: An implementation study for a manual‐guided consultation

Background: The unmonitored use of complementary medicine in patients with cancer can be associated with an increased risk of safety-related issues, such as lower adherence to conventional cancer therapies. Training oncology physicians to advise their patients about the effectiveness and safety of these therapies could improve this situation. Methods: The objective of this study was to develop and pretest a consultation framework that has high potential to be widely implemented. The framework comprises: 1) a systematically developed and tested, manualized, guided consultation; and 2) blended learning training (e-learning and communication skills training workshop) to upskill oncology physicians in advising their patients on complementary and integrative medicine (CIM). For this implementation study, mixed methods were used to develop the manual (literature review, consensus procedure, pilot testing) and the training (questionnaires and interviews with oncology physicians and patients with cancer and an examination of the skills in a setting with standardized patients). Results: The training was tested with 47 oncology physicians from across Germany. The manual-guided consultation (context: general information on the setting and communication techniques; inform: consultation duration and content; capture: previous CIM use; prioritize: focus on consultation; advise: evidence-based CIM recommendations; discuss, advise, accept, or advise against other CIM; concretize advice: summary and implementation; and monitor: documentation) was considered suitable. The structure and time frame (maximum, 20 minutes) of the consultation as well as the training were feasible and well accepted. Conclusions: The current study demonstrates that the KOKON-KTO framework (a German acronym for Competence Network for Complementary Medicine - Consultation Training for Oncology Physicians) is suitable for training oncology physicians. Its implementation can lead to better physician-patient communication about CIM in cancer

App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial

Background: Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective: The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods: Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results: We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions: The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques

Defining Criteria for Guiding Cancer Patients to Find a Reputable Complementary Medicine Provider: Results of a Literature Review and a Consensus Procedure

Purpose: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. Methods: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). Results: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. Conclusion: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients' awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology

Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research

Background: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. Objective: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). Methods: This paper is based on group and expert discussions, and focuses on the researchers' perspectives after four RCTs on mHealth interventions for chronic pain. Results: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. Conclusions: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention. Keywords: behavior change techniques (BCTs); mHealth; mobile apps; pain; recommendations

Development and Implementation of Situational Judgment Tests as an Evaluation Method for Training Oncology Physicians: Application in the KOKON-KTO Training

Situational judgment tests (SJTs) are often used in aptitude testing and present practice-specific challenges. Their implementation into online training programs provides the opportunity to assess learning progress and improve training quality. In this study, text-based SJTs for oncology physicians were developed, validated, and implemented into the KOKON-KTO training which uses a blended learning training format to teach oncology physicians how to consult cancer patients on complementary and integrative medicine (CIM). The SJT was implemented to measure the e-learning results. In the development and validation phase, a total of 15 SJTs (each SJT including 1 best choice answer based on training content and 4 distractors; 9 SJTs for oncologists and 6 SJTs for oncology gynecologists only) were developed by an interprofessional team (n=5) using real-case vignettes and applying an in-depth review process. Best answers were validated by experts (oncologists and oncology gynecologists) with experience in advising cancer patients on CIM. In the implementation and evaluation phase, SJTs were answered by KOKON-KTO training participants (n=19) pre- and post e-learning. Results were analyzed using descriptive measurements, item difficulties, and Cohen’s d for effect size pre- and post-training. The experts (n=12, 49.8% gynecologists) agreed with best choice answers (69.4% for oncology gynecology; 81.5% for oncology) in 12 out of 15 SJTs. Comparing pre- and post-training scores, KOKON-KTO training participants were able to improve knowledge substantially (effect sizes for oncologists d=1.7; oncology gynecologists d= .71). Future studies need to increase the number of experts and SJTs in order to apply further psychometric measurements. As part of the KOKON-KTO study, this project is registered as DRKS00012704 on the “German Clinical Trials Register” (Date of registration: 28.08.2017)

Effects of training oncology physicians advising patients on complementary and integrative therapies on patient‐reported outcomes: A multicenter, cluster‐randomized trial

BACKGROUND: Many patients with cancer do not disclose complementary medicine use but want their physician’s advice on this matter. This study evaluated whether using blended learning (e-learning plus a workshop) to train oncology physicians in providing advice on complementary and integrative medicine (CIM) therapies to their patients with cancer, in addition to distributing an information leaflet on reputable CIM websites, had different effects on patient-reported outcomes for the consultation than only distributing the leaflet. METHODS: In this multicenter, cluster-randomized trial, patients from private practices/hospital departments, recruited by 48 oncology physicians randomly allocated to an intervention group (CIM consultation plus information leaflet) or a control group (information leaflet), received CIM information. Patient-reported outcomes included satisfaction (Patient Satisfaction With Information on Cancer Treatment), readiness to make a decision (Preparation for Decision Making), and physician-patient communication (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and Communication 26 [EORTC QLQ-COMU26]) for the consultation. Qualitative interviews were conducted with a physician subsample. RESULTS: A total of 291 patients (128 in the intervention group and 169 in the control group) advised by 41 physicians participated. Patients in the intervention group rated physician-patient communication higher on all EORTC QLQ- COMU26 scales (mean total score, 84.3 [95% CI, 79.5-89.2] vs 73.6 [95% CI, 69.3- 78.0]; P=.002), were more satisfied with the advice (mean, 4.2 [95% CI, 4.0-4.4] vs 3.7 [95% CI, 3.5-3.8]; P<.001), and were readier to make a decision (mean, 63.5 [95% CI, 57.4-69.6] vs 53.2 [95% CI, 47.8-58.7]; P= .016) than the control group. Physicians who reported patients in both settings seemed satisfied with the advice given. CONCLUSIONS: This study evaluated a novel education intervention for training oncology physicians in providing CIM advice in routine care. Providing structured CIM consultations had positive effects on patient satisfaction, readiness to make decisions, and physician-patient communication

Training oncology physicians to advise their patients on complementary and integrative medicine: An implementation study for a manual‐guided consultation

BACKGROUND: The unmonitored use of complementary medicine in patients with cancer can be associated with an increased risk of safety-related issues, such as lower adherence to conventional cancer therapies. Training oncology physicians to advise their patients about the effectiveness and safety of these therapies could improve this situation. METHODS: The objective of this study was to develop and pretest a consultation framework that has high potential to be widely implemented. The framework comprises: 1) a systematically developed and tested, manualized, guided consultation; and 2) blended learning training (e-learning and communication skills training workshop) to upskill oncology physicians in advising their patients on complementary and integrative medicine (CIM). For this implementation study, mixed methods were used to develop the manual (literature review, consensus procedure, pilot testing) and the training (questionnaires and interviews with oncology physicians and patients with cancer and an examination of the skills in a setting with standardized patients). RESULTS: The training was tested with 47 oncology physicians from across Germany. The manual-guided consultation (context: general information on the setting and communication techniques; inform: consultation duration and content; capture: previous CIM use; prioritize: focus on consultation; advise: evidence-based CIM recommendations; discuss, advise, accept, or advise against other CIM; concretize advice: summary and implementation; and monitor: documentation) was considered suitable. The structure and time frame (maximum, 20 minutes) of the consultation as well as the training were feasible and well accepted. CONCLUSIONS: The current study demonstrates that the KOKON-KTO framework (a German acronym for Competence Network for Complementary Medicine - Consultation Training for Oncology Physicians) is suitable for training oncology physicians. Its implementation can lead to better physician-patient communication about CIM in cancer