Patients' and physicians' disagreement on patients' understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements.

BACKGROUND: Informed consent is a prerequisite for patients included in clinical trials. Trial design, inclusion criteria and legal requirements are increasingly complex. This complexity challenges design and delivery of written and oral trial information to ensure understandable information. To evaluate the level of concordance between patients' and informing physicians' assessments regarding patient understanding of trial information, we carried out a study based on paired questionnaire data from patients and their physicians. These assessments of patient understanding were further correlated with patients' factual knowledge of the information provided. METHODS: This pilot study included patients and physicians immediately after the patients had received information on one of 23 ongoing phase III randomised cancer trials at two Swedish sites. In total, 46 patients and 17 physicians contributed data based on two new questionnaires with seven mirroring questions, where concordance was analysed with McNemar's test. These assessments of patients' self-estimated understanding were further correlated with the Patient Understanding of Research (Q-PUR) questionnaire that assesses factual knowledge of the information provided. RESULTS: For each question, 47-61% of the patient-physician pairs were in concordance regarding their assessments of patients' 'fully understanding' or 'not fully understanding' various aspects of the trial information. For the discordant pairs, the physicians rated patient understanding lower than the patients themselves, for all seven questions. This difference was significant for five of the questions (P ≤ 0.017). The median Q-PUR knowledge score was 11 out of 12, but this score did not significantly correlate with the assessments, either from patients or from physicians. CONCLUSIONS: This study demonstrated a trend for physicians to rate the level of understanding of trial information among potential trial patients lower than the patients themselves. Application of Q-PUR revealed high knowledge scores, but without correlation to the assessments. These findings need validation in an independent setting, with an improved instrument with mirroring questions, and a better-matched measurement of patients' factual knowledge. These results suggest that physicians need to improve their ability to assess patient understanding of clinical trial information, in order to be able to tailor the patients' information individually.

Patients' reasoning regarding the decision to participate in clinical cancer trials: an interview study.

BACKGROUND: Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about participation. The inclusion process is complex, including both oral and written information about the trial. The process of patients' decision-making regarding clinical cancer trials has not yet been sufficiently studied. This interview study aims to explore the process of patients' reasoning regarding the decision to participate in a clinical cancer trial. METHODS: The study is based on 27 individual face-to-face interviews with patients who had decided to participate in a clinical cancer trial. The interviews were audio-recorded and transcribed verbatim and then analysed using inductive content analysis. RESULTS: Content analysis revealed 17 subthemes grouped into five themes: (1) an unhesitating decision to participate; (2) a decision based on flimsy grounds and guided by emotion; (3) feeling safe and secure with my decision; (4) faced with a choice versus what choice do I have? and (5) hoping for help while helping others. The decision to participate in a clinical cancer trial was often immediate and guided by emotions, based on a trusting relationship with healthcare personnel rather than on careful reading of written information. Palliative patients, in particular, sometimes had unrealistic beliefs about the effectiveness of the trial treatment. CONCLUSIONS: It is vital that the decision to participate in a clinical cancer trial is preceded by an honest dialogue about possible positive and negative effects of the trial treatments, including other options such as supportive care in the palliative setting. Our findings also raise the questions of how important written information is for the decision-making process and also whether genuine informed consent is possible. To reach a higher degree of informed consent, it is most important that the oral information is given in a thorough and unbiased manner.

The national program on standardized cancer care pathways in Sweden: Observations and findings half way through.

In 2015, the Swedish government initiated a national cancer reform program to standardize cancer care pathways. Primary aims included shortened waiting times among patients with suspected cancer, increased patient satisfaction and reduced regional variation. The implementation phase of the program is now more than half way through and both achievements and challenges have been identified. The ongoing evaluation demonstrates that professional engagement and adjustments on the meso- and micro-level of the system are essential to achieving sustainable improvements. Waiting times have shortened for the pathways launched first, and patients are satisfied with a more transparent process. Physicians in primary care are satisfied to inform patients about the pathways but point out problems with comorbidity and complicated diagnostic procedures related to unspecific symptoms. Mechanisms and ethical considerations behind possible crowding-out effects need to be thoroughly highlighted and discussed with staff and management. The results so far appear promising but meso- and micro-levels of the system need to be more involved in the design processes.

The 2015 National Cancer Program in Sweden: Introducing standardized care pathways in a decentralized system.

Starting in 2015, the Swedish government has initiated a national reform to standardize cancer patient pathways and thereby eventually speed up treatment of cancer. Cancer care in Sweden is characterized by high survival rates and a generally high quality albeit long waiting times. The objective with the new national program to standardize cancer care pathways is to reduce these waiting times, increase patient satisfaction with cancer care and reduce regional inequalities. A new time-point for measuring the start of a care process is introduced called well-founded suspicion, which is individually designed for each cancer diagnosis. While medical guidelines are well established earlier, the standardisation is achieved by defining time boundaries for each step in the process. The cancer reform program is a collaborative effort initiated and incentivized by the central government while multi-professional groups develop the time-bound standardized care pathways, which the regional authorities are responsible for implementing. The broad stakeholder engagement and time-bound guidelines are interesting approaches to study for other countries that need to streamline care processes.

Patient representatives' views on patient information in clinical cancer trials.

BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. RESULTS: Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Balancing life with an increased risk of cancer: lived experiences in healthy individuals with Lynch syndrome.

Possibilities to undergo predictive genetic testing for cancer have expanded, which implies that an increasing number of healthy individuals will learn about cancer predisposition. Knowledge about how an increased risk of disease influences life in a long-term perspective is largely unknown, which led us to explore lived experiences in healthy mutation carriers with Lynch syndrome. Individual interviews were subjected to descriptive phenomenological analysis. Four constitutions, namely, family context, interpretation and transformation, approach to risk and balancing life at risk were identified and formed the essence of the phenomenon "living with knowledge about risk." Family context influences how experiences and knowledge are interpreted and transformed into thoughts and feelings, which relates to how risk is approached and handled. The constitutions influence each other in a dynamic relationship and create a balancing act between anxiety and worry and feelings of being safe and in control.

Sense of coherence and self-concept in Lynch syndrome.

OBJECTIVE: Most individuals who learn about hereditary cancer manage well, but identification of subgroups who find this knowledge burdening would allow psychosocial intervention. The objective of the study was to assess sense of coherence (SOC) in individuals with Lynch syndrome with comparison to a general population and correlation to self-concept. METHODS: A total of 345 individuals with Lynch syndrome completed the 13-item SOC scale and the 20-item Lynch syndrome self-concept scale. SOC scores were compared to a general Danish population and were correlated to self-concept estimates in individuals with Lynch syndrome. Characteristics of subgroups with adverse scores were described. RESULTS: Individuals with Lynch syndrome reported SOC scores similar to the general population. SOC and self-concept correlated well with a correlation coefficient of -0.51. Subsets with convergent and divergent scores, which may reflect different effects from knowledge about hereditary cancer, were identified. CONCLUSION: Individuals with Lynch syndrome report SOC scores similar to the general population. SOC and self-concept correlate well but allow identification of subset who report adverse outcome and may be relevant for targeted intervention.

Family perspectives in lynch syndrome becoming a family at risk, patterns of communication and influence on relations.

BACKGROUND: A growing number of individuals are diagnosed with hereditary cancer. Though increased levels of anxiety and depression have been demonstrated around the time of genetic counselling, most individuals handle life at increased risk well. Data have, however, been collected on individual basis, which led us to focus on family perspectives of hereditary cancer. METHODS: Lynch syndrome represents a major type of hereditary colorectal and gynaecological cancer. We preformed open-ended interviews with 27 informants from 9 Lynch syndrome families. Inductive content analysis revealed three major themes: transition to a risk family, patterns of communication and influence on family relations and individual roles. RESULTS: Family members described how learning about Lynch syndrome shifted focus from daily issues to concerns about cancer. Changes in communication related to difficulties in talking to children about heredity and informing new family members and distant relatives about an increased risk of cancer. Influence on relations was exemplified by family members taking on different roles, e.g. females often being responsible for coordinating information about heredity and providing support. Families in which members had experienced cancer at young age typically informed children soon after learning about heredity and at young age, whereas families with experience of cancer at higher age postponed information and thereby also genetic counselling. CONCLUSIONS: Three major family perspectives are described in Lynch syndrome families; becoming a risk family, patterns of communication and influence on family relations. Since these issues are central, our findings suggests that such family perspectives should be considered during genetic counselling in order to contribute to information spread, help family members cope with the increased risk, and motivate family members at risk to undergo surveillance.

Limited impact on self-concept in individuals with Lynch syndrome; results from a national cohort study.

An increasing number of individuals seek genetic counseling and hereby learn about hereditary cancer in the family. Lynch syndrome is associated with an inherited high risk for colorectal and gynecological cancer, but knowledge about how family members at risk perceive their situation is limited. We used the national Danish HNPCC register to collect data on self-concept from 413 individuals with Lynch syndrome. The recently developed Lynch syndrome self-concept scale contains 20 items within two subscales related to stigma-vulnerability and bowel symptom-related anxiety. Significantly higher total scores, indicating a greater impact on self-concept, were reported by females and by individuals with experience from cancer in close relatives, whereas individuals with less formal education scored significantly higher on the stigma and vulnerability subscale. Scores in the upper quartile were more often reported by women (odds ratio 1.8) and by individuals with less education (OR 1.8). This study provides the first extended use of the Lynch syndrome self-concept scale and suggests that the majority of the Danish mutation carriers adapt well to the situation, though knowledge about the increased risk of cancer seem to have a greater impact in females, individuals with less education and those with experience of cancer in close relatives.

Validation of a self-concept scale for Lynch syndrome in different nationalities.

Learning about hereditary cancer may influence an individual's self-concept, which otherwise represents a complex but stable cognitive structure. Recently, a 20-statement self-concept scale, with subscales related to stigma-vulnerability and bowel symptom-related anxiety, was developed for Lynch syndrome. We compared the performance of this scale in 591 mutation carriers from Denmark, Sweden and Canada. Principal component analysis identified two sets of linked statements-the first related to feeling different, isolated and labeled, and the second to concern and worry about bowel changes. The scale performed consistently in the three countries. Minor differences were identified, with guilt about passing on a defective gene and feelings of losing one's privacy being more pronounced among Canadians, whereas Danes more often expressed worries about cancer. Validation of the Lynch syndrome self-concept scale supports its basic structure, identifies dependence between the statements in the subscales and demonstrates its applicability in different Western populations.

Knowledge about hereditary nonpolyposis colorectal cancer; mutation carriers and physicians at equal levels.

BACKGROUND: Identification and adequate management of individuals at risk for hereditary nonpolyposis colorectal cancer (HNPCC) is crucial since surveillance programmes reduce morbidity and mortality. We investigated knowledge about key features of HNPCC in at risk individuals and physicians in surgery, gynecology and oncology. METHODS: Data were collected using a questionnaire which was answered by 67 mutation carriers and 102 physicians from the southern Swedish health care region. The statements were related to colorectal cancer, heredity and surveillance and the physicians were also asked questions about cancer risks and surveillance strategies. RESULTS: Both groups answered questions on colorectal cancer risk, surveillance and genetic testing well, whereas answers about inheritance and risks for HNPCC associated cancer were less accurate. Only half of the family members and one third of the physicians correctly estimated the risk to inherit an HNPCC predisposing mutation. Among family members, young age (<57 years), female sex and recent genetic counseling significantly correlated with better results. Physicians generally underestimated the risk of HNPCC associated cancers and three out of four suggested a later starting age for surveillance than recommended. CONCLUSION: The finding of similar levels of knowledge about key features of HNPCC in at risk individuals and physicians reflect the challenge physicians face in keeping up to date on hereditary cancer and may have implications for the clinical management and professional relations with HNPCC family members.

Discrepancies between estimated and perceived risk of cancer among individuals with hereditary nonpolyposis colorectal cancer.

Communicating cancer risk and recommending adequate control programs is central for genetic counseling. Individuals affected by hereditary nonpolyposis colorectal cancer (HNPCC) are at about 80% life-time risk of colorectal cancer and for female carriers 40-60% risk of endometrial cancer and 10-15% risk of ovarian cancer. The perceived risk among mutation carriers may, however, deviate from the risk communicated and has been demonstrated to influence adherence to control programs. We investigated the perceived cancer risk among HNPCC mutation carriers (n = 47) and correlated the findings to individual characteristics. A perceived risk of colorectal cancer above 60% was reported by 22/45 individuals, and only one out of five mutation carriers reported a perceived risk > 80%. Female mutation carriers, individuals below age 50, and individuals who received their oncogenetic counseling within 1 year prior to the study reported higher, albeit not significantly, perceived risks of colorectal cancer. Higher perceived risks were also reported by individuals who had lost a parent to HNPCC-related cancer at early age, whereas individuals with a personal history of cancer did not report a higher perceived risk. Regarding gynecological cancer, 6/18 females reported a perceived risk of 40-60% for endometrial cancer, whereas the remaining women both underestimated and overestimated their risk, and none of the women referred to the risk of ovarian cancer. We conclude that despite educational efforts and an increasing amount of data on the cancer risk in HNPCC, a minority of the mutation carriers report a perceived risk at the same level as that communicated during oncogenetic counseling.

Captured voices in cancer: experiences from networking between individuals with experiential and professional knowledge.

BACKGROUND: Patients needs and experiences attract increasing attention within health care. In order to generate knowledge about the voices that emerge from collaborative experiences between members of patient associations for cancer patients (PACP) and health care professionals (HCPs), we studied a permanent network aimed at improving cancer care through increased attention to the cancer patients' view and experiences. METHODS: Open-ended interviews were carried out with 16 individuals; 6 PACP members and 10 HCPs, and after transcription the texts were analysed by inductive content analysis. RESULTS: Four voices, which represent various experiences from networking, were identified; the hesitant voice, the enlightened voice, the liberated voice, and the representative voice. The hesitant voice reflects uncertainty experienced when the participants were exposed to different views and opinions within the network. The enlightened voice reflects new points of view and gain of knowledge. The liberated voice signifies trust, balance, and confidence related to individual experiences and responsibilities being viewed in a broader perspective. The representative voice is derived from the transformation of experiences and responsibilities through insight, understanding, and new perspectives. CONCLUSION: Networking between representatives for PACPs and HCPs may help the participants manage uncertainty, strengthen the patient's perspective and provide new views on common issues. The different voices identified in this study demonstrate that both PACP members and HCPs distanced themselves from their individual experiences in order to be perceived as unselfish and knowledgeable within the network. Although the climate was characterized by trustfulness, the members' unique positions need to be defined in order to obtain an optimal balance between the groups and prevent members' patient experiences of losing their character by learning to much from the HCPs. Increased understanding of the hesitant, the enlightened, the liberated, and the representative voices, and awareness of experiential versus professional knowledge of cancer may facilitate and probably improve future networking efforts.

Benefits from membership in cancer patient associations: relations to gender and involvement.

Cancer patient associations report a growing number of members and increasing possibilities to influence health care, but knowledge about the members' views on the benefit of involvement is scarce. We therefore investigated how members (n = 1742) of Swedish patient associations for breast cancer and prostate cancer rate the benefit of membership for their physical and psychological well-being and social adjustment to cancer. Using a scoring scale, 2/3 of the members reported that membership had benefit for psychological well-being, whereas half of the members reported benefit for physical well-being and social adjustment. Individuals who had been actively involved in board work and/or contact person activities within the associations reported significantly more benefit for all three parameters. Gender differences were observed with men, represented by individuals affected by prostate cancer, reporting greater benefit for all three parameters, although especially evident for psychological well-being. Individuals who obtained membership within two years of diagnosis reported greater benefit for psychological well-being and social adjustment compared to those who became members later. In conclusion, members in patient associations for cancer report benefit particularly for their psychological well-being and actively involved members and men affected by prostate cancer perceive the greatest benefit from membership.

Patients' involvement in improving cancer care: experiences in three years of collaboration between members of patient associations and health care professionals.

OBJECTIVE: The aim of this study was to explore how members of patient associations (PACPs) and health care professionals (HCPs) experience collaboration in a network initiated by the health care system and aimed at improving cancer care. METHODS: The participants were asked to describe, after 1 and 3 years, their experiences of collaboration. Data collected were in the form of a written answer to a single, open-ended question, and the answers were analysed using inductive content analysis. RESULTS: The analysis revealed four themes: the impact of processes that occur within the network, the impact of learning, the impact of innovation and development in cancer care, and the impact of PACP members' personal cancer experience. Statements about the impact of the processes that occur within the network dominated at both occasions. CONCLUSION: This study of experiences of collaboration provides new data on the importance ascribed to such efforts between patients in an organised association and HCPs. PRACTICE IMPLICATIONS: We suggest that differences in perceptions and expectations should be taken into account in future collaborations between representatives of patient associations and of health care systems in order to reach out and to influence developments in cancer care.

Supporter or obstructer; experiences from contact person activities among Swedish women with breast cancer.

BACKGROUND: Swedish patient associations for breast cancer patients (PABCPs) offer patients with breast cancer unlimited meetings with a breast cancer survivor, a contact person (CP). We applied the voluntary action perspective in this interview study with members of Swedish PABCPs in order to explore how women with breast cancer experienced their contact with a CP from a PABCP. METHODS: Audio-taped narratives from 8 women were analysed using Reissman's monitoring and Gee's analysis structure. RESULTS: Three themes appeared: 1. Shared experiences give new perspectives on having cancer, 2. Feelings of isolation are a part of the identity of the illness and 3. Relations with others enable self-help. However, the relationship with the CP is sensitive to timing, correct information and understanding. CONCLUSIONS: CPs act as sounding boards and should optimally have capacity for listening, gives support and act as partner in this conversation. On the other hand, CPs should be aware that their presence and limited general medical knowledge could at times disturb the patient's psychological recovery and strengthen feelings of isolation. Thus, PABCPs must be careful in selecting CPs and offer relevant educational activities related to the themes identified herein.

Motives for becoming and remaining member of patient associations: a study of 1,810 Swedish individuals with cancer associations.

Patient associations for cancer patients (PACPs) are increasing in number as well as in the number of members. We utilised a questionnaire to investigate how members of 13 PACPs motivated their memberships. The study included 1,810 individuals who had been treated for breast cancer, gynaecological cancer, or prostate cancer. Through questionnaires these individuals were asked to articulate why they became and chose to remain members. Descriptive statistics and content analyses were used to analyse the open and structured questions. Motives for membership reflected both benefits for the individuals and the welfare of others; themes such as 'needs related to having cancer' (reported by 33% as motives for becoming members; 14% for remaining members), 'wanted to use the PACP's information and activities' (24%; 38%) and 'wanted to support the PACP and its possibilities to have an impact' (9%; 20%) were dominant. The theme 'needs and experiences related to having cancer' was more common among members with breast cancer (38%) and ovarian cancer (36%) than among members with prostate cancer (25%), whereas 53% of men with prostate cancer reported 'wanted to use the PACP's information and activities' compared to 19-9% among female members. The motives showed that needs related to having cancer and that activities and information offered by the PACPs were important to the members, as were their beliefs that the PACP prompted issues that were important to the members.

Stress management training as related to glycemic control and mood in adults with Type 1 diabetes mellitus.

Relationships between attending a stress management and relaxation-training program, glycemic control (HbA(1c)) and mood were examined in two randomised groups of 31 persons with Type 1 diabetes. The program involved group-education 2 h a week for 14 weeks. Whereas one group received the program, the other acted as a control group and received the program later. HbA(1c) was measured and subjects filled out a mood adjective checklist before the start of intervention and both 1 month and 1 year after completing it. In both groups, significant positive mood changes were obtained, but no significant changes in HbA(1c) values occurred. No significant relationship was found between measures of change in HbA(1c) and of changes in mood. For those attending the group-sessions less frequently, the HbA(1c) values were significantly worse on each of the three measurement occasions than the values of those attending more frequently. The effectiveness of the program, with its failure to improve glycemic control but enhancing the mood of participants, is discussed in terms of characteristics of the sample and various methodological issues as well as in comparison with results of similar studies involving Type 1 and Type 2 diabetes.