Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.

PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.

PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

Undergo motivational interviewing training

Communication Skills Training

Medical Chart Review

Questionnaire Administration

Attend phone or in-person motivational interviewing coaching sessions

Tobacco Cessation Counseling

John Holland

This pilot clinical trial studies how well provider training works in increasing patient tobacco cessation counseling and referrals for patients with cancer undergoing radiation therapy. Health care provider training in motivational interviewing techniques and utilizing tobacco cessation resources may help doctors understand how health care providers can effectively increase their confidence in talking to patients about tobacco cessation counseling.

PRIMARY OBJECTIVES:

I. To determine if training providers on tobacco cessation resources increases the frequency of counseling and referrals at initial and follow-up consultations for cancer patients who use tobacco and are scheduled to receive radiation at Oregon Health and Science University (OHSU).

SECONDARY OBJECTIVES:

I. Increase provider frequency of tobacco use quantification and type. II. Increase frequency of provider assessment of tobacco cessation readiness in current users.

III. Increase frequency and types of tobacco cessation resources and medicines offered and utilized.

IV. Increase frequency and type of follow-up planned if referred to cessation resource.

OUTLINE:

MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.

PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.

PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy

Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study

Will be compared between the cohort of pre and post intervention. Will be summarized using descriptive statistics and compared using chi-square test by tumor type.

Will be summarized using descriptive statistics and compared using chi-square test by tumor type.

Will be tested using a chi-squared test. If any expected cell count in the contingency table is lower than 5, we will instead use Fisher's exact test.

Will be summarized using descriptive statistics and compared using chi-square test by tumor type. Will be tested using Z tests of proportion.

Oregon Health and Science University

OHSU Knight Cancer Institute

Associate Professor

Behaviors and Mental Disorders

Symptoms and General Pathology

Nervous System Diseases

Depressive Disorder

Depression

Low Back Pain

Back Pain

Pain

Neurologic Manifestations

Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.

Group 2 receives three decision aids. This group does not receive any feedback from the SPI.

Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.

Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.

1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.

Webinar

Participants will receive 3 decisions aids to review.

DA viewing

Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction

SPI feedback

Karen Sepucha, PhD

The Health Decision Sciences Center (HDSC) staff has deployed different approaches to training clinicians to engage patients in shared decision making for common medical tests and treatments. The purpose of the study is to compare the effectiveness of shared decision making (SDM) skills training courses using standardized patient interactions (SPI) and written evaluations.

There is limited evidence on approaches to training clinicians to engage patients in shared decision making for common medical tests and treatments. The purpose of the study is to compare the effectiveness of different approaches to shared decision making (SDM) skills training. Participants will be randomly assigned to either receive two decision aids or a webinar to review. Participants will also be randomly assigned to receive feedback on standardized patient interaction rating their shared decision making skills and highlighting opportunities for improvement or not. Clinician participants will be assigned to one of four intervention groups using a 2x2 factorial design:

Group 1: Decision aid viewing with feedback Group 2: Decision aid viewing and no feedback Group 3: webinar with feedback Group 4: webinar and no feedback

The pilot study will provide evidence on the comparative effectiveness and feasibility on training formats to determine if:

* Clinicians improved in SDM communication skills
* Clinicians have an increased confidence to use SDM with their patients
* The training is acceptable to clinicians

A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians

A Pilot Randomized Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians

Transcripts from standardized patient interactions (SPI) will be scored using Braddock's Informed Decision Making (IDM) framework to assess shared decision making skills. Scores with the Braddock's Informed Decision Making Framework range from 0 to 9; the higher scores are better. We subtracted the scores of the baseline SPI collected before the intervention from the second SPI collected 4-6 weeks later, after the intervention, to determine the change in IDM score for each participant and then compared change scores across study arms.

Partners HealthCare

Massachusetts General Hospital

Director Health Decision Sciences Center

Group 1 receives three decision aids and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.

DA viewing: Participants will receive 3 decisions aids to review.

SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction

DA Viewing With SPI Feedback

Group 2 receives three decision aids. This group does not receive any feedback from the SPI.

DA viewing: Participants will receive 3 decisions aids to review.

DA Viewing With no SPI Feedback

Group 3 receives an online, interactive webinar that focuses on SDM skills in clinical encounters and feedback on their standardized patient (SPI) interaction rating their shared decision making skills and highlighting opportunities for improvement.

Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.

SPI feedback: Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction

Webinar With SPI Feedback

Group 4 receives an online, interactive webinar that focuses on SDM skills in clinical encounters. This group does not receive any feedback from the SPI.

Webinar: 1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.

Webinar With no SPI Feedback

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Karen Sepucha

Change in Braddock's Informed Decision Making Score

Overall Study

Infections

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.

Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60- minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes.

Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics.

Undergo communication strategy intervention

Communication Intervention

Healthcare Activity

Survey Administration

Parth Shah

This trial investigates how a communication strategy works in increasing human papillomavirus (HPV) vaccines in community pharmacies among adolescents. Although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. The purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about HPV vaccination in order to increase HPV vaccination rates.

OUTLINE:

AIM 1: Participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of HPV vaccination in pharmacies.

AIM 2: Participants provide feedback on survey questions via cognitive testing. Pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing HPV vaccination to children aged 9-17 in their pharmacies. Pharmacy staff then attend two, 60-minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending HPV and other vaccines. Pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes.

Pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics.

Additionally, pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of HPV vaccination, and the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, acellular pertussis; meningococcal conjugate; influenza).

Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study

PROMOTE Pilot Study: Pharmacy Multimodal Communication Strategy to Promote HPV Vaccination

Assess experiences and perceptions among parents and pharmacy staff on the challenges of obtaining/delivering HPV vaccination in pharmacies. Assessments will be done through semi-structured interviews informed by the Theoretical Domains Framework. Qualitative data will be analyzed using framework-guided rapid analyses

Assess experiences and perceptions among parents and pharmacy staff on how pharmacies support, promote, and increase access and opportunities for HPV vaccination for children. Assessments will be done through semi-structured interviews informed by the Theoretical Domains Framework. Qualitative data will be analyzed using framework-guided rapid analyses

Obtain feedback from pharmacy staff on how the communication strategy being tested addresses barriers to obtaining/delivering HPV vaccination in pharmacies. Assessments will be done through pre and post intervention surveys.

Obtain feedback from pharmacy staff on how the communication strategy being tested can help improve obtaining/delivering HPV vaccination in pharmacies. Assessments will be done through pre and post intervention surveys.

Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the acceptability of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.

Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the appropriateness of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.

Will use adapted, validated, four-item pre/post survey measure to assess pharmacy staff's report of the feasibility of providing HPV vaccination to children and of the communication strategy to support HPV vaccination.

Will use adapted, validated pre/post survey measures to assess pharmacy staff's report of the self-efficacy (i.e., confidence in their ability) to provide HPV vaccination.

Will conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, measured as the average HPV vaccination rate per pharmacist at each pharmacy.

Will assess the impact of the communication strategy on adoption of other adolescent vaccines using pre-post data analysis methods like Wilcoxon signed-rank test or other nonparametric tests appropriate for small sample statistics.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Patients participate in a psycho-educational program focused on medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.

Participate in psycho-educational program

psychosocial assessment and care

educational intervention

communication skills training

questionnaire administration

Jeanelle Folbrecht

This pilot clinical trial studies psycho-educational program in increasing knowledge and satisfaction and decreasing distress in younger patients with cancer receiving treatment. Psycho-educational program may increase knowledge and satisfaction and decrease distress in younger patients with cancer receiving treatment

PRIMARY OBJECTIVES:

I. Providing a psycho-educational group to young adults while examining the feasibility of such a group with patients on treatment.

II. Examining effectiveness of the program through evaluating pre-post changes in participant distress, evaluating increases in participant' knowledge regarding disease issues and coping, and evaluating participant satisfaction.

OUTLINE:

Patients undergo psycho-educational program comprising medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.

After completion of study treatment, patients are followed up for 30 days.

Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment

Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction

A questionnaire was developed to measure participant satisfaction with the format and material of the psycho-educational program. Satisfaction measures will be provided for completion at the end of sessions 2 through 5 and 30 days post intervention. Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.

A questionnaire was developed based on the psycho-educational material to assess increases in knowledge and retention. The questionnaire will be administered pre-intervention and 30 days post-intervention. Additionally, relevant items from the questionnaire will be administered at the end of the relevant educational session. For instance, self image questions from the questionnaire will be administered at the end of the self-image session in addition to the pre and post administration of the entire questionnaire. Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.

City of Hope Medical Center

This group of 30 physicians will immediately attend the intervention communication skills training program (experimental group).For this experimental group, the first assessment will take place before the first training session and the second recording after the last session. This assessment involves the analyses of communicational, physiological and psychological variables recorded in the context of an encounter with a simulated advanced stage cancer patient.

This group of 30 physicians will attend the intervention communication skills training in a delayed manner (control group). For this control group, the first and the second recording will take place with a four-month interval. This assessment involves the analyses of communicational, physiological and psychological variables recorded in the context of an encounter with a simulated advanced stage cancer patient.

The general aim of the communication skills training program is to help physicians learn effective communication skills in contexts of high uncertainty. The training will last 30 hours, will be spread over 4 months. The training will be conducted by group of 3 subjects. The training will include mainly role-plays, theoretical information and modeling techniques. A training manual has been developed to increase content standardization and reduce potential group or trainee biases. The role-plays will be based on clinical cases brought up by the participants.

Communication skills training

Yves Libert, Pr.

Livia Peternelj, M.A.

Livia Peternelj

yves libert

Isabelle Merckaert, Pr.

Yves Libert

Darius Razavi

Christine Reynaert

Isabelle Bragard

Isabelle Merckaert

Background: Although previous studies have reported the efficacy of communication skills training programs (CST), specific training addressing communication about uncertainty and hope in oncology has not yet been studied. This paper describes the study protocol of a randomized controlled trial assessing the efficacy of a CST program aimed at improving physician ability to communicate about uncertainty and hope in encounters with cancer patients.

Methods: Physician participants will be randomly assigned in groups (n = 3/group) to a 30-hour CST program (experimental group) or to a waiting list (control group). The training program will include learner-centered, skills-focused, practice-oriented techniques. Training efficacy is assessed in the context of an encounter with a simulated advanced stage cancer patient at baseline and after the CST for the experimental group, and after four months for the waiting-list group. Efficacy assessments will include communicational, psychological and physiological measures. Group-by-time effects will be analyzed using a generalized estimating equation (GEE). A power analysis indicated that a sample size of 60 (30 experimental and 30 control) participants will be sufficient to detect effects.

Discussion: The current study will aid in the development of effective CST programs to improve physician ability to communicate about uncertainty and hope in encounters with cancer patients.

1. Aim of the trial A randomized longitudinal study assessing the efficacy of a CST program aimed at improving physician communication about uncertainty and hope with cancer patients will be conducted. Efficacy of the program will be assessed by the analysis of changes over time in physician communication skills and physician psychological and physiological health. These assessments will be performed in the context of an encounter with a simulated advanced-stage cancer patient.
2. Subjects Participants will be physicians that are specialists or residents, have a practice including cancer patients and speak French. The study was approved by a central ethics committee (Jules Bordet Institute, Cancer Center of the Université Libre de Bruxelles) and all participants will provide written informed consent.
3. Study Design Participating physicians will be randomly assigned to either the experimental group or the control group (Figure 1). After baseline assessment, participants in the experimental group will attend a 4-month training program followed by a post assessment. Participants in the control group will be placed on a training program waitlist after baseline assessment and will be reassessed four to five months later. The process of randomization after baseline will allow for a double-blind assessment at baseline.
4. CST Program 4.1. CST aims The aim of the CST is to improve the ability of physicians to communicate about uncertainty and hope with cancer patients.

   4.2. CST logistics The CST is a manualized program comprised of ten 3-hour sessions (30 hours) spread over four to five months. Each training group will include three physicians. The training will be conducted at locations and times choosen by the physicians within each group. The trainer of the experimental group will be an experienced facilitator who will conduct all training sessions (Y.L.). The training timetable will not include more than two 3-hours sessions in one day. Physicians will have the opportunity to register in groups of three or individually. In the latter case, physicians will be assigned to groups according to geographical proximity.

   4.3. CST Sessions The first session of the training program will include a general introduction to training and a modeling session. Sessions two to four will focus on appropriate communication skills for addressing uncertainty and hope according to a model detailed in a training manual. During sessions five to seven, participants will learn to transfer their newly-learned skills to clinical practice. Finally, during sessions eight to ten, skills learned during the training program will be consolidated.

   4.4. CST Program The CST program will include theoretical information giving about uncertainty and hope in cancer care (based on psychodynamics, cognitive-behavioral and systemic theories), modeling and role-playing.
   * Theoretical information giving The CST trainer will provide theoretical information on communication skills needed to address uncertainty and hope in encounters with cancer patients. These skills will focus on assessing patient expectations about the future and restructuring patient understandings with appropriate information when needed; and assessing patient hopes about the future and supporting those which are realistic \[47\]. All skills will be based on a collaborative and bidirectional communication process between physicians and patients on topics such as disease prognosis or expected and unexpected medical, psychological and social effects of cancer treatments. A specific algorithmic theoretical model has been designed to aid physicians in the implementation of these communication skills.
   * Modeling During the first CST session, physicians will observe a 16-minute video of a simulated interview in which the trainer acts as a physician communicating with a patient suffering from advanced cervical cancer. In the scenario, the patient has come for chemotherapy treatment and is requesting reassurance about treatment efficacy.

   The modeling session will empahsize three factors: 1) physician attitudes necessary to address uncertainty and hope, 2) patient's reactions to the discussion of uncertainty and hope and 3) the need to set up a safe and comfortable setting in which to model communication skills needed to address uncertainty and hope. After the video, physicians will be given one hour to debrief and react to the simulated interview.

   • Role-playing Throughout training, participants will be invited to participate in interactive role-playing with immediate and circular feed-backs \[48\]. Physicians will be asked to identify a clinical situation for the focus of the role-play situation. In session two to four, physicians will be asked to define a situation that would be highly uncomfortable in terms of uncertainty and hope management. In training sessions five to seven, physicians will be asked to identify clinical situations in which the transfer of learned communication skills would be difficult. Finally, in training sessions eight to ten, physicians will be asked to identify clinical situations during which the transfer of acquired skills would be uncomfortable.

   During role-play, the physician who reports the clinical situation will take on the role of the patient. This will allow role-play to be as realistic as possible. The small group context will promote an interactive session. During role-play, the "patient" will be exposed to the ways that he and his two colleagues are communicating in repeated rotations. During each rotation, the facilitator will suggest alternative strategies that were taught in the theoritical model and shown in the modeling video.

   • Transfering to clinical practice Each training session will start with a 15-minute summary of material learned since the beginning of the training program along with a debriefing from participants of attempts to transfer the learned skills to their clinical practice. Each training session will end with a 10-minute summary of the skills learned during the session, the difficulties that may have been encountered, and a proposal for the transfer of newly learned skills to future encounters with patients.
5. Assessment Procedure The performance status, disease status and communication skills among cancer patients vary widely and as such, the use of standardized encounters with simulated patients has been recommended to assess the efficacy of CST programs designed for healthcare professionals \[49\]. The assessment procedure for the current study will involve the video recording of an encounter between the participating physician and a simulated advanced stage cancer patient. Participating physicians will be assessed individually. An investigator, not involved in the training program, will present each subject with questionnaires. The assessment procedure (Figure 2) will include 7 steps: (1) continuous monitoring of heart rate, (2) relaxation exercise, (3) administration of questionnaires, (4) review of the simulated cancer patient medical chart, (5) administration of the second set of questionnaires, (6) encounter with the simulated cancer patient and (7) final set of questionnaires. Perceived stress will be measured seven times throughout the assessment procedure.

5.1. Simulated Patient Encounter The simulated patient case was written by an oncologist and a psycho-oncologist at the medical oncology unit and the psycho-oncology clinic at the Jules Bordet Institute, Cancer Center of the Université Libre de Bruxelles. The simulated patient case was developed to increase physician uncertainty about predefined medico-psycho-social components and available evidence-based treatments. The simulated patient is a 36-year-old woman with advanced cancer. She is facing a third recurrence (hepatic metastasis) of a breast cancer that had previously been treated with surgery, hormone therapy, radiation therapy and chemotherapy. She has agreed to start a new chemotherapy treatment. The scenario specifies that the patient has requested a meeting with a physician to help her cope with her treatment decision. Participants will be instructed to address and respond to the concerns of the simulated patient and to take the time they need for doing that. The simulated patient will be played by an actress experienced in simulated patient encounters and will be trained to maintain a standardized script and behavior. Regular feedback sessions will be held to help the actress maintain reproducibility \[50\]. The simulated patient encounters will take place at the Communication Laboratory (LabComm) of the Centre de Psycho-Oncologie (Brussels, Belgium).

5.2. Psychological Assessments Participating physicians will be asked to complete a set of psychological questionnaires prior to reading the patient medical file. Data on socioprofessional characteristics, practices in oncology and sense of mastery of the communication skills needed to address uncertainty and hope with cancer patients will be collected. A second set of psychological questionnaires administered immediately prior to the encounter with the simulated patient will gather information on the perceived realism of the medical chart of the simulated patient, agreement with the treatment decision, outcome expectancies on the medical, psychological and social status of the simulated patient, perceived uncertainty and hope regarding the medical, psychological and social outcomes of the simulated patient, and psychological reactions to uncertainty regarding the medical, psychological and social outcomes of the simulated patient. Finally, a third set of psychological questionnaires will be administered immediately after meeting with the simulated patient. These questions will pertain to agreement with the treatment decision, satisfaction regarding the encounter with the simulated patient, and the sense of mastery regarding the communication skills used to address uncertainty and hope with the simulated patient. These psychological questionnaires will allow the assessment of predictors and correlates of communication skill learning used to address uncertainty and hope with the simulated patient.

5.3. Communication Assessments The encounter with the simulated patient will be video recorded and transcribed. Physician communication skills will be analyzed using three tools. The French communication content analysis software, LaComm (Centre de Psycho-Oncologie, Brussels, Belgium; http://www.lacomm.be/) analyzes verbal communication (in medicine in general and in oncology in particular) and identifies turns of speech and the type and content of speech. The explanation of how this software works has been detailed in previous publications \[42, 51\]. The Multidimensional analysis of Patient Outcome Predictions (MD.POP) is a reliable tool used to measure verbal expressions that address the clinical future of a patient during medical encounters. This coding system allows one to manually identify, code, and score detailed verbal content from a medical encounter transcript that addresses a patient's clinical future. The detailed MD.POP codebook is available upon request. Finally, a specific interaction-process analysis system assessing communication skills addressing hope and uncertainty will be developed for the study \[52\].

5.4. Physiological Assessments Throughout all assessment procedures, physician heart rate will be monitored to assess the impact of the training program on the physiological arousal associated with communication about uncertainty and hope with the simulated patient. This assessment procedure has previously been used to measure the effect of CST on the physiological arousal of residents breaking bad news in a simulated task \[53\].

5.5. Statistical Analyses The primary outcome of the current study is the physicians' increased communication performance after training during this encounter. A power analysis has been performed, based on a previous longitudinal study assessing physicians' communication performance composite score in an encounter with a simulated advanced-stage cancer patient (Mean = 26; SD = 8) \[54\]. This power analysis was conducted considering 4 independent conditions according to the time (time 1 versus time 2) and the group (experimental versus control group). As there is no previous study assessing the efficacy of an intensive communication skills training program on physicians' communication about uncertainty and hope, it was hypothesized that physicians in the control group will maintain a stable performance score from time 1 to time 2. It was also hypothesized that physicians in the experimental group will improve their performance score by 20% from time 1 to time 2. Sample size calculation has been based on an 80% power, a one-sided α = 0.05 t-test and an effect size of 0.65. Considering this power analysis, 60 evaluable physicians are therefore needed for the efficacy assessment. Considering a drop-out rate of 20%, 12 physicians should be moreover recruited (72 physicians in total). It should be recalled at this level that one trainer only will conduct the training of the experimental group. Secondary, to assess also the CST program efficacy, group-by-time effects will be performed using generalized estimating equation (GEE) on psychological, physiological and communicational assessments performed during the encounter with the simulated patient.

BIBLIOGRAPHY

1. Snyder, C.R., et al., The Will and the Ways: Development and Validation of an Individual-Differences Measure of Hope. Journal of Personality and Social Psychology, 1991. 60(4): p. 570-585.
2. de Figueiredo, M.N., et al., ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training. BMC cancer, 2015. 15(1): p. 503.
3. Razavi, D., et al., Testing health care professionals' communication skills: The usefulness of highly emotional standardized role-playing sessions with simulators. Psycho-Oncology, 2000. 9(4): p. 293-302.
4. Libert, Y., et al., Predictors of physicians' satisfaction with their management of uncertainty during a decision-making encounter with a simulated advanced stage cancer patient. Patient education and counseling, 2016. 99(7): p. 1121-1129
5. Liénard, A., et al., Is it possible to improve residents breaking bad news skills? A randomised study assessing the efficacy of a communication skills training program. British Journal of Cancer, 2010. 103(2): p. 171-177.
6. Gibon, A.-S., et al., Development of the LaComm 1.0, A French medical communication analysis software: A study assessing its sensitivity to change. Patient Education and Counseling, 2016.
7. Ménard C., et al., Development of the Multi-Dimensional Analysis of Patient Outcome Predictions during Medical Encounters. Patient Education and Counseling, Submitted.
8. Meunier, J., et al., The effect of communication skills training on residents' physiological arousal in a breaking bad news simulated task. Patient Education Counseling, 2013. 93(1): p. 40-7.

Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program

Communication About Uncertainty and Hope: A Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program for Physicians Caring for Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy	NCT03135782	Breast Carcinom... Caregiver Head and Neck C... Lung Carcinoma Prostate Carcin... Tobacco Use	Communication S... Medical Chart R... Questionnaire A... Tobacco Cessati...	-	OHSU Knight Cancer Institute
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians	NCT02871739	Depression Low Back Pain	Webinar DA viewing SPI feedback	18 Years -	Massachusetts General Hospital
Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study	NCT04660331	Human Papilloma...	Communication I... Communication S... Healthcare Acti... Healthcare Acti... Survey Administ...	18 Years -	Fred Hutchinson Cancer Center
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment	NCT01817335	Malignant Neopl... Psychosocial Ef...	psychosocial as... educational int... communication s... questionnaire a...	18 Years - 30 Years	City of Hope Medical Center
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians	NCT02871739	Depression Low Back Pain	Webinar DA viewing SPI feedback	18 Years -	Massachusetts General Hospital
A Trial Comparing Approaches to Shared Decision Making Skills Training for Clinicians	NCT02871739	Depression Low Back Pain	Webinar DA viewing SPI feedback	18 Years -	Massachusetts General Hospital
Randomized Controlled Trial Assessing the Efficacy of a Communication Skills Training Program	NCT02836197	Physician Patie...	Communication s...	18 Years - 85 Years	Jules Bordet Institute

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