Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned.

BACKGROUND: To test seven different strategies for recruitment in a randomized controlled trial, to report documented response data from each strategy, and to discuss recruitment challenges. METHODS: We used 5 opt-in (potential participants have to do something active to contact or be contacted by the researcher) and 2 opt-out (potential participants have the option to decline being contacted about a study) recruitment strategies from February 2013 until July 2014 to contact 1562 cancer patient candidates for participation in a randomized controlled trial. For each of these cancer patients a caregiver was also invited to take part in the study. RESULTS: Of the 1562 candidates, 22.6 % were ineligible on initial contact, 56.7 % declined to participate on initial contact, and 8.9 % agreed orally to participate but did not complete the enrollment. The 2 opt-out strategies, on-site recruitment and routine care letters recruitment, yielded the highest number of recruited participants with 79 dyads and 58 dyads respectively, constituting 42.7 % and 31.4 % of the total number of enrolled candidates. The 5 opt-in recruitment approaches yielded 49 dyads for the study. Almost half of these dyads were recruited using the approach termed "relying on providers at the hospital." CONCLUSIONS: In this study, opt-out recruitment strategies appeared to be the most effective. TRIAL REGISTRATION: Registration number NCT01867723 , registered February 2012.

Middle Managers' Experiences and Role in Implementing an Interactive Tailored Patient Assessment eHealth Intervention in Clinical Practice.

The role of nurse and physician managers is considered crucial for implementing eHealth interventions in clinical practice, but few studies have explored this. The aim of the current study was to examine the perceptions of nurse and physician managers regarding facilitators, barriers, management role, responsibility, and action taken in the implementation of an eHealth intervention called Choice into clinical practice. Individual qualitative interviews were conducted with six nurses and three physicians in management positions at five hospital units. The findings revealed that nurse managers reported conscientiously supporting the implementation, but workloads prevented them from participating in the process as closely as they wanted. Physician managers reported less contribution. The implementation process was influenced by facilitating factors such as perceptions of benefits from Choice and use of implementation strategies, along with barriers such as physician resistance, contextual factors and difficulties for front-line providers in learning a new way of communicating with the patients. The findings suggest that role descriptions for both nurse and physician managers should include implementation knowledge and implementation skills. Managers could benefit from an implementation toolkit. Implementation management should be included in management education for healthcare managers to prepare them for the constant need for implementation and improvement in clinical practice.

Evaluation of Sisom: A computer-based animated tool to elicit symptoms and psychosocial concerns from children with cancer.

PURPOSE: In pediatric oncology, clear communication regarding symptom occurrence between clinicians and children is essential in order to provide safe and effective care. Mobile technology provides a means to enhance the standard clinician-patient interview, particularly among children, who are well versed in the use of technology. To help children identify and voice their concerns in the health care setting, researchers created Sisom, an animated computer tool for children and young people with serious and chronic illnesses. The purposes of this study of 100 dyads of patients 7-12 years of age and their parents were to: compare participants' reports of symptom occurrence using Sisom to a standard symptom checklist and determine the time requirements, ease of use, and perceived usefulness of the Sisom tool by children with cancer and their parents. METHODS: Child and parent participants completed both Sisom and the Memorial Symptom Assessment Scale. Symptoms on the two tools were compared and 20 items were similar to allow for comparisons. RESULTS: Children reported a significantly higher number of these 20 symptoms using Sisom as compared to the MSAS (i.e., 6.8 versus 4.9 symptoms, p < 0.001). A similar pattern was noted for parental proxy reports (i.e., 8.7 versus 5.7 symptoms, p < 0.001). Sisom was completed in less than 30 min, with high ratings of ease of use and perceived usefulness from parent participants. CONCLUSIONS: Sisom provides a systematic and engaging method to elicit symptom reports from children for use in clinical care and research.

Comparing effects in regular practice of e-communication and Web-based self-management support among breast cancer patients: preliminary results from a randomized controlled trial.

BACKGROUND: While Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care. OBJECTIVE: Our aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months' follow-up data in a 12-month trial. METHODS: We recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time. RESULTS: Patients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups. CONCLUSIONS: In spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects. TRIAL REGISTRATION: Clinicaltrials.gov:NCT00971009; http://clinicaltrials.gov/show/NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y).

Health care professionals' perspectives of the experiences of family caregivers during in-patient cancer care.

Being a family member of a patient who is being treated in an acute care setting for cancer often involves a number of challenges. Our study describes Norwegian cancer care health professionals' perceptions of family members who served as family caregivers (FCs) and their need for support during the in-hospital cancer treatment of their ill family member. Focus group discussions were conducted with a multidisciplinary team of 24 experienced social workers, physicians, and nurses who were closely involved in the patients' in-hospital cancer treatment and care. Drawing on qualitative hermeneutic analysis, four main themes describe health professionals' perceptions of FCs during the patient's in-hospital cancer care: an asset and additional burden, infinitely strong and struggling with helplessness, being an outsider in the center of care, and being in different temporalities. We conclude that it is a challenge for health care professionals to support the family and create room for FC's needs in acute cancer care. System changes are needed in health care, so that the patient/FC dyad is viewed as a unit of care in a dual process of caregiving, which would enable FCs to be given space and inclusion in care, with their own needs simultaneously considered alongside those of the patient.

Supporting cancer patients in illness management: usability evaluation of a mobile app.

BACKGROUND: Mobile phones and tablets currently represent a significant presence in people's everyday lives. They enable access to different information and services independent of current place and time. Such widespread connectivity offers significant potential in different app areas including health care. OBJECTIVE: Our goal was to evaluate the usability of the Connect Mobile app. The mobile app enables mobile access to the Connect system, an online system that supports cancer patients in managing health-related issues. Along with symptom management, the system promotes better patient-provider communication, collaboration, and shared decision making. The Connect Mobile app enables access to the Connect system over both mobile phones and tablets. METHODS: The study consisted of usability tests of a high fidelity prototype with 7 cancer patients where the objectives were to identify existing design and functionality issues and to provide patients with a real look-and-feel of the mobile system. In addition, we conducted semistructured interviews to obtain participants' feedback about app usefulness, identify the need for new system features and design requirements, and measure the acceptance of the mobile app and its features within everyday health management. RESULTS: The study revealed a total of 27 design issues (13 for mobile apps and 14 for tablet apps), which were mapped to source events (ie, errors, requests for help, participants' concurrent feedback, and moderator observation). We also applied usability heuristics to identify violations of usability principles. The majority of violations were related to enabling ease of input, screen readability, and glanceability (15 issues), as well as supporting an appropriate match between systems and the real world (7 issues) and consistent mapping of system functions and interactions (4 issues). Feedback from participants also showed the cancer patients' requirements for support systems and how these needs are influenced by different context-related factors, such as type of access terminal (eg, desktop computer, tablet, mobile phone) and phases of illness. Based on the observed results, we proposed design and functionality recommendations that can be used for the development of mobile apps for cancer patients to support their health management process. CONCLUSIONS: Understanding and addressing users' requirements is one of the main prerequisites for developing useful and effective technology-based health interventions. The results of this study outline different user requirements related to the design of the mobile patient support app for cancer patients. The results will be used in the iterative development of the Connect Mobile app and can also inform other developers and researchers in development, integration, and evaluation of mobile health apps and services that support cancer patients in managing their health-related issues.

Reducing errors through a web-based self-management support system.

Web-based self-management support systems SMSS, can successfully assist a wide range of patients with information and self-management support. O or as a stand-alone service, are e-messages. This study describes how one component of a multi component SMSS, an e-message service, in which patients with breast cancer could direct questions to nurses, physicians or social workers at the hospital where they were being treated, had an influence on safety and continuity of care. Ninety-one dialogues consisting of 284 messages were analysed. The communications between patients and the healthcare team revealed that the e-messages service served as a means for quality assurance of information, for double-checking and for coordination of care. We give examples of how an e-mail service may improve patients' knowledge in a process of taking control over their own care - increasingly important in a time of growing complexity and specialization in healthcare. It remains to be tested whether an e-message service can improve continuity of care and prevent or mitigate medical mishaps.

Living close to a person with cancer: a review of the international literature and implications for social work practice.

To help family caregivers (FCs), social workers need to understand the complexity of FC's experiences and challenges. For this systematic review, several relevant, multidisciplinary electronic databases were searched. Of 1,643 titles identified, 108 articles met the inclusion criteria and are included in this review. Various experiences, symptoms, and burden related to caregiving responsibilities are described and discussed. The understanding evolving from this study about the FC's own health risk, caregiver burden, and experiences over time can enhance a social worker's awareness of an FC's challenging situation and the potential impact this has on the FC's ability to provide care to the patient.

Nurses' experiences of using an interactive tailored patient assessment tool one year past implementation.

BACKGROUND: Despite evidence of benefits, integration of patient-centered communication in clinical practice is challenging. Interactive tailored patient assessment (ITPA) tools can contribute to a more patient-centered care approach. However, little research has examined the impact of such tools on nursing care once they have been implemented. OBJECTIVE: To explore nurses' experiences of the benefits of and barriers to using an ITPA called Choice, in cancer care one year after its implementation. METHODS: This investigation is a part of a larger study examining the use of Choice in cancer care. Four focus group interviews were conducted with 20 nurses experienced in using the Choice application. The data were analyzed using qualitative content analysis. RESULTS: Three themes and nine sub-themes emerged: (1) "Choice as facilitator for shared understanding and engagement in patients' own care," with three sub-themes: preparing both patient and nurse for communication, shared engagement in care planning, and giving the patients a voice; (2) "enhancing the patients' strengths," with two sub-themes: releasing patient's internal strengths and confirming "normalcy" for the patient; and (3) "new challenges for the nurse," with four sub-themes: organizational challenges, interactions with technology, a need for training in communication skills, and new ethical challenges. CONCLUSIONS: Findings suggest that, from nurses' perspectives, integration of ITPAs such as Choice in clinical practice offers many benefits that can contribute to patient-centered care. However, to reap these benefits, use of such tools must receive equal priority as other routines, and require sufficient time, space and competence. Choice also challenged nurses' professional roles and created dilemmas such as nurses' ambivalence regarding patients' levels of disclosure of sensitive issues and the nurses' ability to respond to them. Although patient-centered care is advocated as model for good clinical practice, this is not always internalized. Tools such as Choice may help to make such a shift happen.

Evaluation of different features of an eHealth application for personalized illness management support: cancer patients' use and appraisal of usefulness.

OBJECTIVE: The purpose of this paper was to describe patients' use of a multi-component eHealth application, WebChoice, designed to support cancer patients in illness management. With WebChoice patients can monitor their symptoms, obtain individually tailored, evidence-based self-management support, ask questions to a clinical nurse specialist, communicate with other patients in a Forum, and use a diary. METHODS: To better understand what components were most helpful, we analyzed user logs of breast and prostate cancer patients who participated in the experimental arm of an RCT to test effects of WebChoice on clinical outcomes. Patients could freely use the system for one year. After 6 months into the study, participants received questionnaires asking about reasons for using the different WebChoice components and their usefulness. RESULTS: 103 (64%) patients actively used WebChoice, on average 60 times. The Forum and asking questions to the nurse were used the most, yet there were large individual variations in use patterns. Also, patients used different WebChoice components for different reasons. The e-mail communication with nurses was valued highest. DISCUSSION: Differences were found between breast and prostate cancer patients and between patients with a first time diagnosis and metastases or recurrences. The large variations among patients in their use of WebChoice components demonstrate that patients' needs for support vary. CONCLUSION: The use patterns and patients' appraisals of usefulness in this study provide important insights into cancer patients' information and communication behavior that are important for further improvements and the design of eHealth applications for illness management support.

How user characteristics affect use patterns in web-based illness management support for patients with breast and prostate cancer.

BACKGROUND: Frequently eHealth applications are not used as intended and they have high attrition rates; therefore, a better understanding of patients' need for support is warranted. Specifically, more research is needed to identify which system components target different patient groups and under what conditions. OBJECTIVE: To explore user characteristics associated with the use of different system components of a Web-based illness management support system for cancer patients (WebChoice). METHODS: For this secondary post hoc analysis of a large randomized controlled trial (RCT), in which WebChoice was tested among 325 breast cancer and prostate cancer patients who were followed with repeated measures for 1 year, usage patterns of 162 cancer patients in the intervention arm with access to WebChoice were extracted from the user log. Logistic regression was performed to identify patterns of associations between system use and patient characteristics. Latent class analyses (LCA) were performed to identify associations among the use of different system components and levels of social support, symptom distress, depression, self-efficacy, and health-related quality of life. RESULTS: Approximately two-thirds (103/162, 63.6%) of the patients logged on to WebChoice more than once, and were defined as users. A high level of computer experience (odds ratio [OR] 3.77, 95% CI 1.20-11.91) and not having other illnesses in addition to cancer (OR 2.10, 95% CI 1.02-4.34) increased the overall probability of using WebChoice. LCA showed that both men with prostate cancer and women with breast cancer who had low scores on social support accompanied with high levels of symptom distress and high levels of depression were more likely to use the e-message component. For men with prostate cancer, these variables were also associated with high use of the self-management advice component. We found important differences between men with prostate cancer and women with breast cancer when associations between WebChoice use and each user characteristic were analyzed separately. High use of all components was associated with low levels of social support among women with breast cancer, but not among men with prostate cancer. High use of e-messages, advice, and the discussion forum were associated with high levels of depression among women with breast cancer, but not among men with prostate cancer. For men with prostate cancer (but not women with breast cancer), high use of symptom assessments, advice, and the discussion forum were associated with high levels of symptom distress. However, it is unclear whether these findings can be attributed to differences related to diagnosis, gender, or both. CONCLUSIONS: This study provides evidence that different user characteristics are associated with different use patterns. Such information is crucial to target Web-based support systems to different patient groups. LCA is a useful technique to identify subgroups of users. In our study, e-messages and self-management advice were highly used components for patients who had low levels of social support and high illness burden, suggesting that patients with these characteristics may find such tools particularly useful. TRIAL REGISTRATION: ClinicalTrials.gov NCT00710658; http://clinicaltrials.gov/ct2/show/NCT00710658 (Archived by WebCite at http://www.webcitation.org/6EmEWZiwz).

Talking about feelings and worries in cancer consultations: the effects of an interactive tailored symptom assessment on source, explicitness, and timing of emotional cues and concerns.

BACKGROUND: Patients are experts of their own symptoms and worries, but tend not to express their concerns spontaneously in the consultation. Even when emotions are brought up, they are discussed briefly. OBJECTIVE: The objective of this study was to examine the impact of an interactive tailored patient assessment (Choice) on communication of emotional cues and concerns expressed by cancer patients in terms of source of initiation of cues/concern, explicitness, timing during the consultation, and consultation type (inpatient/outpatient). METHODS: We audiotaped and coded consultations between cancer patients and nurses or physicians in 1 control group (n = 99) with standard consultations and 1 intervention group (n = 97) where patients used Choice prior to the consultation. Direct and interaction effects were tested using multilevel analyses. RESULTS: In the Choice intervention group, there were significantly more frequent and more explicit expressions of cues and concerns; more clinician-initiated concerns occurred during the first 10 minutes; and it was more likely for any cue or concern to be succeeded by a subsequent one. In consultations with many cues/concerns, these were on average more emotionally descriptive or explicit and occurred somewhat earlier in the consultation in the Choice group. Furthermore, more cues/concerns were expressed in inpatient consultations with nurses than in outpatient consultations with physicians. CONCLUSION: Cancer patients' expressions of cues and concerns do not occur at random. More cues/concerns are expressed early in the consultation, in consultations with nurses, and in the Choice intervention group. IMPLICATION FOR PRACTICE: Choice may be a useful clinical tool. Use of Choice might aid cancer patients in handling their emotions.

Effects of an interactive tailored patient assessment on patient-clinician communication in cancer care.

BACKGROUND: To test the effect of Choice, an interactive tailored patient assessment (ITPA) tool on the number and types of symptoms addressed during consultations with cancer patients, cancer patients' active participation during consultation with clinicians, and clinicians' responses. METHOD: A total of 193 consultations were audio taped and coded with the task-oriented part of Roter Interactive Assessment System. In addition, we recorded the initiator of each coded utterance (clinician or patient) as defined by Verona Coding Definitions of Emotional Sequences and indicated the symptoms addressed in a list of all symptoms within the Choice ITPA. Of the 193 consultations, 99 were standard consultations that served as a control group. In the 94 intervention group consultations, patients utilized the Choice ITPA prior to the consultation, and the assessment summary was available to both patients and clinicians. We compared the two groups in both multilevel and multivariate analyses. RESULTS: We found significantly more symptoms addressed in the intervention group as compared with the control group. We also found that the patients asked more questions in the intervention group, indicating that they were more active participants when utilizing Choice. The clinicians also provided more information in the intervention group. CONCLUSION: The Choice ITPA was successful in making cancer patients more active participants in the consultation with their clinician.

Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial.

BACKGROUND: Cancer patients experience many physical and psychosocial problems for which they need support. WebChoice is an Internet-based, interactive health communication application that allows cancer patients to monitor their symptoms and problems, provides individually tailored information and self-management support, e-communication with expert cancer nurses, and an e-forum for group discussion with other patients. OBJECTIVE: The objective of this study was to examine the effects of WebChoice on symptom distress (primary outcome), depression, self-efficacy, health-related quality of life, and social support (secondary outcomes). METHODS: In this 1-year repeated-measures randomized controlled trial, 325 breast and prostate cancer patients were randomized into 1 experimental group with access to WebChoice and 1 control group who received URLs of publicly available cancer Web sites. RESULTS: Group differences on symptom distress were significant only for the global symptom distress index on the Memorial Symptom Assessment Scale (slope estimate, -0.052 [95% confidence interval, -0.101 to -0.004]; t = 4.42; P = .037). There were no significant group differences on secondary outcomes. Additional analyses showed significant within-group improvements in depression in the experimental group only. In the control group, self-efficacy and health-related quality of life deteriorated significantly over time. CONCLUSION: This randomized controlled trial is one of the first to evaluate effects of an interactive health communication application to support cancer patients in illness management on symptoms. Although only 1 hypothesis was partially supported, the combined results show a clear trend toward better scores in the intervention group on most outcome measures. IMPLICATIONS FOR PRACTICE: If findings can be supported with additional research, WebChoice may become an important tool to support nursing care that can equip cancer patients to better manage their illness.

To live close to a person with cancer--experiences of family caregivers.

The purpose of this study was to obtain a deeper understanding of the experiences of Family Caregivers (FC) living close to a patient with cancer. This article reports on the findings from individual interviews with 15 FCs of patients with cancer. The interview transcripts were analyzed using qualitative hermeneutic analysis. This study revealed that living close to a cancer patient over the course of his or her illness affected many aspects of FCs lives in significant ways. Their experiences can be summarized with two major themes: (1) living in an ever changing life world and (2) balancing between conflicting interests and dilemmas. This study contributed to deeper insights into FC's experiences than previously reported in the literature.

Cancer patients' experiences of using an Interactive Health Communication Application (IHCA).

Interactive Health Communication Applications (IHCAs) are increasingly used in health care. Studies document that IHCAs provide patients with knowledge and social support, enhance self- efficacy and can improve behavioural and clinical outcomes. However, research exploring patients' experiences of using IHCAs has been scarce. The aim of this study was to explore cancer patients' perspectives and experiences related to the use of an IHCA called WebChoice in their homes. Qualitative interviews were conducted with infrequent, medium and frequent IHCA users-six women and four men with breast and prostate cancer. The interviews were transcribed and analyzed inspired by interactionistic perspectives. We found that some patients' perceived WebChoice as a "friend," others as a "stranger." Access to WebChoice stimulated particularly high frequency users to position themselves as "information seeking agents," assuming an active patient role. However, to position oneself as an "active patient" was ambiguous and emotional. Feelings of "calmness", "normalization of symptoms", feelings of "being part of a community", feeling "upset" and "vulnerable", as well as "feeling supported" were identified. Interaction with WebChoice implied for some users an increased focus on illness. Our findings indicate that the interaction between patients and an IHCA such as WebChoice occurs in a variety of ways, some of which are ambivalent or conflicting. Particularly for frequent and medium frequency users, it offers support, but may at the same time reinforce an element of uncertainty in their life. Such insights should be taken into consideration in the future development of IHCAs in healthcare in general and in particular for implementation into patients' private sphere.

Cancer patients' expressions of emotional cues and concerns and oncology nurses' responses, in an online patient-nurse communication service.

OBJECTIVE: To (1) investigate emotional cues and concerns (C&C) of cancer patients expressed in e-mail communication with oncology nurses in an online patient-nurse communication service (OPNC), and (2) explore how nurses responded to patients' C&C. METHODS: 283 e-messages sent from 38 breast and 22 prostate cancer patients and 286 e-responses from five oncology nurses were coded with the Verona Coding Definitions of Emotional Sequences. RESULTS: We identified 102 cues and 33 concerns expressed in patients' messages. Cues indicating expression of uncertainty or hope, occurred most frequently (in 38.5% of messages), followed by concerns (in 24.4% of messages). Nurses responded to 85.2% of patients' C&Cs; more than half of patients' C&Cs were met with a mixture of information giving and empathic responses. CONCLUSION: Patients with breast and prostate cancer express many C&C in e-mail communications with oncology nurses, who demonstrated satisfactory sensitivity to patients' emotions in their responses to patients. PRACTICE IMPLICATIONS: Offering e-communication with oncology nurses to cancer patients is a promising and feasible supplement to usual care to address and relieve patients' concerns and emotional distress during illness and recovery.

Health assets in nursing documentation of cancer care.

Patients' experiences, knowledge and preferences, as well as more person-centered care need to be implemented in clinical support systems and are central values and outcomes of eHealth. Health assets represent such information. The concept of health assets was explored and described based on analysis of nursing documentation in cancer patients' records. A convenience sample from 100 records, available from a larger study, resulted in 43 records that met the inclusion criteria. These were analyzed using content analysis methods. A mean of 3.2 health assets was documented in these records, and 61% of the descriptions of assets quoted patients. Assets were found most often in the admission notes (49%), but no information was found that described or indicated an intended use or follow up in the nursing documentation.

Effects of an interactive tailored patient assessment tool on eliciting and responding to cancer patients' cues and concerns in clinical consultations with physicians and nurses.

OBJECTIVE: To test the effect of Choice, an interactive tailored patient assessment tool (ITPA), on cancer patients' expressed cues and concerns (C&Cs), and clinicians' responses to these C&Cs. METHODS: 97 experimental group consultations, where patients used the Choice ITPA to report their symptoms and problems in preparation to their consultation, were compared to 99 control group consultations. All consultations were audio-taped and coded using the Verona Coding Definitions of Emotional Sequences (VR-CoDES). RESULTS: We identified 473 cues and 109 concerns with a mean number of 3.0 (SD=3.2). The most frequent utterance was cue B (45.2%), indicating expression of uncertainty or hope. We found more C&Cs in consultations with the Choice ITPA compared to the control group (p<0.01), and in consultations with nurses compared to physicians (p<0.001). No differences in clinicians' response types in the two groups were found. However, significant differences in response type between nurses and physicians were found. CONCLUSION: The Choice ITPA was an effective tool to disclose cancer patients' cues and concerns. PRACTICE IMPLICATIONS: The Choice ITPA proved to be an effective intervention for cancer patients to express more C&Cs, but should be accompanied with communication skills training to potentially produce more patient-centered responses from the clinicians. (ClinicalTrials.gov number NCT00857103.)