Survivorship care plans have a negative impact on long-term quality of life and anxiety through more threatening illness perceptions in gynecological cancer patients: the ROGY care trial.

PURPOSE: Prior results from the registration system oncological gynecology (ROGY) care trial showed that survivorship care plans (SCPs) increased threatening illness perceptions in gynecological cancer survivors, but it remained unclear whether this would result in poorer physical and psychosocial outcomes. The aim of the current study is to assess the direct and indirect effects of SCPs on health-related quality of life (HRQoL) and anxiety and depression, through illness perceptions. METHODS: Twelve hospitals in the South of the Netherlands were randomized to providing 'SCP care' or 'usual care.' Newly diagnosed endometrial and ovarian cancer patients completed questionnaires after initial treatment (endometrial, 221 [75%]; ovarian, 174 [71%]) and after 6, 12, and 24 months. SCPs were automatically generated after initial treatment by the oncology providers through the web-based ROGY. Illness perceptions were measured after initial treatment and HRQoL and anxiety and depression after 6, 12, and 24 months. RESULTS: Structural equation models showed that endometrial cancer patients who experienced more symptoms or concern due to the SCP reported worse social functioning (ß = - 0.82; p = 0.01) and more fatigue, insomnia, pain, and anxiety (ß = 0.58-0.86, p < 0.05) within 12 months after treatment. Ovarian cancer patients who had lower trust that the treatment would cure their disease due to the SCP reported worse emotional functioning 6 months after treatment (ß = 0.27, p = 0.02). CONCLUSIONS: Current results show that SCPs may have negative effects on HRQoL and anxiety in patients who experience more threatening illness perceptions due to the SCP. We should be aware of the potential negative consequences of SCPs. Trial Registration clinicaltrials.gov Identifier: NCT01185626.

Effects of Survivorship Care Plans on patient reported outcomes in ovarian cancer during 2-year follow-up - The ROGY care trial.

OBJECTIVE: The aim of this study was to assess the long-term impact of an automatically generated Survivorship Care Plan (SCP) on patient reported outcomes in ovarian cancer in routine clinical practice. Outcome measures included satisfaction with information provision and care, illness perceptions and health care utilization. METHODS: In this pragmatic cluster randomized trial, twelve hospitals in the South of the Netherlands were randomized to 'SCP care' or 'usual care'. All newly diagnosed ovarian cancer patients in the 'SCP care' arm received an SCP that was automatically generated by the oncology provider, by clicking a button in the web-based Registrationsystem Oncological GYnecology (ROGY). Ovarian cancer patients (N=174, mean age 63.3, SD=11.4; all stages) completed questionnaires directly after initial treatment and after 6, 12 and 24months. RESULTS: First questionnaires were returned from 61 (67%) ovarian cancer patients in the 'SCP care' arm and 113 (72%) patients in the 'usual care' arm. In the 'SCP care' arm, 66% (N=41) of the patients reported receipt of an SCP. No overall differences were observed between the trial arms on satisfaction with information provision, satisfaction with care or health care utilization. Regarding illness perceptions, patients in the 'SCP care' arm had lower beliefs that the treatment would help to cure their disease (overall, 6.7 vs. 7.5, P<0.01). CONCLUSIONS: SCPs did not increase satisfaction with information provision or care in ovarian cancer patients. Our trial results suggest that ovarian cancer patients may not benefit from an SCP. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01185626.

The impact of cancer survivorship care plans on patient and health care provider outcomes: a current perspective.

BACKGROUND: To help the growing number of cancer survivors deal with the challenges of cancer survivorship, survivorship care plans (SCPs) were recommended by the Institute of Medicine (IOM) in 2006. The SCP is a formal document that contains both a tailored treatment summary and a follow-up care plan. Since the IOM recommendation 10 years ago, the implementation in daily clinical practice is minimal. Several studies have investigated the effects of SCPs on patient-reported outcomes and oncology and primary care providers (PCPs), but the quantity and quality of these studies are limited. RESULTS: The first four randomized trials comparing SCP delivery with usual care failed to show a positive effect on satisfaction with information provision, satisfaction with care, distress or quality of life. SCPs did improve the amount of information provided and communication of PCPs with medical specialists and patients. A recent small trial that changed the focus from SCP as primarily an information delivery intervention to a behavioral intervention did observe positive effects on self-reported health, lower social role limitations and a trend towards greater self-efficacy. Gaps in knowledge about SCPs include uncertainty about content and length of the SCP; whether it should be delivered online or on paper; the timing and frequency of delivery; which health care provide should deliver SCP care. Finally, cost-effectiveness of SCP interventions has received limited attention. CONCLUSION: Currently, there is not enough evidence to warrant large-scale implementation of SCPs, or to abandon SCPs altogether. Emphasis on the SCP process and survivor engagement, supporting self-management may be an important way forward in SCP delivery. Whether this is beneficial and cost-effective on the long term and among different groups of cancer survivors needs further investigation.

Factors influencing implementation of a survivorship care plan-a quantitative process evaluation of the ROGY Care trial.

PURPOSE: The aim of this study is to investigate the factors that influence implementation of Survivorship Care Plans (SCPs) in the intervention arm of the ROGY Care trial by (1) assessing the level of SCP receipt in the ROGY Care trial and (2) identifying patient- and provider-level factors that influence SCP receipt. METHODS: Between 2011 and 2015, a pragmatic cluster randomized-controlled-trial was conducted on the effects of automatically generated SCPs. Endometrial (N = 117) and ovarian (N = 61) cancer patients were allocated to 'SCP care', as provided by their SCP care providers (N = 10). Associations between SCP receipt (self-reported SCP receipt and actually generated SCPs), patient-factors (socio-demographic-, clinical-, and personality factors), and care provider factors (profession and a-priori motivation regarding SCP provision) were tested in univariate analysis. The odds ratios of factors influencing self-reported SCP receipt were estimated with a multivariate regression model. RESULTS: Of all patients in the SCP care arm (N = 178), SCPs were generated by the care provider for 90 % of the patients and 70 % of the patients reported that they had received an SCP. Patients with older age, ovarian cancer, type D (distressed) personality, and patients that completed the questionnaire a longer period of time after the SCP consult were more likely to report no SCP receipt. CONCLUSIONS: SCP receipt was influenced by patient- but not care-provider factors. IMPLICATIONS FOR CANCER SURVIVORS: Certain patient groups were less likely to report SCP receipt. Whether all patients are in need of an SCP, requires further investigation. If they do, more efforts need to be made towards the implementation of SCPs.

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial.

PURPOSE: This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. METHODS: Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. RESULTS: In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. CONCLUSION: The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more empowered patients should be investigated further.

Survivorship Care Plans to inform the primary care physician: results from the ROGY care pragmatic cluster randomized controlled trial.

PURPOSE: This study assesses the effect of sending a Survivorship Care Plan (SCP) to primary care physicians (PCP) on the communication of the PCP with the medical specialist and the patient and to describe PCPs' opinions regarding the SCP. METHODS: In a pragmatic cluster randomized controlled trial conducted in 12 hospitals, the PCP of endometrial and ovarian cancer patients received usual information, while in addition the SCP-care arm received a copy of the patient's SCP. RESULTS: A questionnaire was returned by 266 PCPs (76%). One third of the PCPs in the SCP-care arm indicated having received an SCP. PCPs in the SCP-care arm were more likely to have had personal contact with the medical specialist (52 vs. 37%, p = 0.01) but were equally satisfied with the information as PCPs in the usual care arm (7.2 vs. 6.9 on a scale from 1 to 10, p = 0.25). Of all PCPs, 82% indicated they would want to receive an SCP in the future. A quarter of the PCPs who received an SCP reported that the SCP supported contact with the patient. However, the SCP was found too long. CONCLUSIONS: Supplying an SCP to PCPs potentially has a positive effect on the communication between the PCP and the medical specialist. The SCP should be concise and focused on PCPs' needs, such as contact information and tailored information on patient diagnosis, treatment, and possible consequences. IMPLICATIONS FOR CANCER SURVIVORS: In the light of transition of cancer care to PCPs, survivors may benefit from improved information provision and communication.

The role of health literacy in perceived information provision and satisfaction among women with ovarian tumors: a study from the population-based PROFILES registry.

OBJECTIVE: To assess the association of subjective health literacy (HL) and education with perceived information provision and satisfaction. METHODS: Women (N=548) diagnosed with an ovarian or borderline ovarian tumor between 2000 and 2010, registered in the Eindhoven Cancer Registry, received a questionnaire including subjective HL, educational level, perceived information provision, and satisfaction with the information received. Multiple linear and logistic regression analyses were performed, controlled for potential confounders. RESULTS: Fifty percent of the women responded (N=275). Thirteen percent had low and 41% had medium subjective HL. Women with low HL reported less perceived information provision about medical tests, and were less satisfied with the information received compared to women with high HL. Low educated women reported that they received more information about their disease compared to highly educated women. CONCLUSION: Low subjective HL among women with ovarian tumors is associated with less perceived information provision about medical tests and lower information satisfaction, whereas low education is associated with more perceived information provision about the disease. PRACTICE IMPLICATIONS: HL should not be overlooked as a contributing factor to patients' perceived information provision and satisfaction. Health care providers may need training about recognizing low HL.

Oncology providers' evaluation of the use of an automatically generated cancer survivorship care plan: longitudinal results from the ROGY Care trial.

PURPOSE: Previous studies have merely investigated oncology providers' a priori attitudes toward SCPs. The purpose of the current study was to longitudinally evaluate oncology providers' expectations and actual experiences with the use of an automatically generated Survivorship Care Plan (SCP) in daily clinical practice. METHODS: Between April 2011 and October 2012, the participating oncology providers (i.e., gynecologists, gynecologic oncologists, oncology nurses) provided usual care or SCP care to 222 endometrial and 85 ovarian cancer patients included in the Registrationsystem Oncological GYnecology (ROGY) Care trial. All (n = 43) oncology providers in both arms were requested to complete a questionnaire before and after patient inclusion regarding their expectations and evaluation of SCP care. RESULTS: Before patient inclusion, 38 (88%; 21 SCP, 17 usual care), and after patient inclusion, 35 (83%; 20 SCP, 15 usual care) oncology providers returned the questionnaire. After patient inclusion, oncology providers were generally satisfied with the SCP (M = 7.1, SD = 1.3, with 1 = not at all-10 = very much) and motivated to keep using the SCP (M = 7.9, SD = 1.5). Most providers (64%) encountered barriers. Twenty-five percent felt they used more time for consultations (M = 7.3 min, SD = 4.6). However, self-reported consultation time did not differ between before (M = 21.8 min, SD = 11.6) and after patient inclusion (M = 18.7, SD = 10.6; p = 0.22) or between SCP care (M = 18.5, SD = 10.3) and usual care (M = 22.0, SD = 12.2; p = 0.21). CONCLUSIONS: Oncology providers using the SCP were generally satisfied and motivated to keep using the SCP. However, the findings of the current study suggest that even when the SCP can be generated automatically, oncology providers still have difficulties with finding the time to discuss the SCP with their patients. IMPLICATIONS FOR CANCER SURVIVORS: If SCP care is indeed effective, overcoming the perceived barriers is needed before large-scale implementation in order for cancer survivors to fully benefit from the potential advantages of SCPs.

Health care use among endometrial cancer survivors: a study from PROFILES, a population-based survivorship registry.

OBJECTIVE: Increasing numbers of endometrial cancer survivors place a high burden on the health care system. This study describes the number of visits to the general practitioner, the medical specialist and other care services, compared with the general population, and factors associated with this health care use: age, marital status, education, body mass index, comorbidity, years since diagnosis, and radiotherapy. METHODS: Survivors of stage I to stage II endometrial cancer diagnosed between 1999 and 2007 were selected from the Eindhoven Cancer Registry. Survivors (N = 742) completed a questionnaire about their demographic characteristics and health care use. Cancer-related information was retrieved from the Eindhoven Cancer Registry. RESULTS: Endometrial cancer survivors visited their medical specialist more often (3.4 times per year) than the general population. In relation to their cancer, they visited their general practitioner once and their medical specialist twice per year. Use of additional care services was low (14%) but higher among younger survivors (33%). Younger women were more likely to make cancer-related visits to their general practitioner, whereas more highly educated women were less likely to visit their general practitioner and more likely to make cancer-related medical specialist visits. Women with more comorbid conditions were more likely to make general and cancer-related general practitioner visits. Radiotherapy and body mass index were not related to health care use. CONCLUSIONS: Endometrial cancer survivors use more health care than women in the general population. Younger women visit their general practitioner more often in relation to their cancer and use more additional care services. More highly educated survivors were more likely to visit a medical specialist in relation to their cancer.

Follow-up practice in endometrial cancer and the association with patient and hospital characteristics: a study from the population-based PROFILES registry.

OBJECTIVE: To examine to what extent endometrial cancer survivors experienced follow-up according to the Dutch national guidelines, and to identify associations between follow-up care consumption and socio-demographic and clinical characteristics, Health-Related Quality of Life (HRQL), and worry (including fear of recurrence). Patients' preferences with the received follow-up care were also evaluated. METHODS: All patients diagnosed with endometrial cancer FIGO stages I-II between 1999 and 2007, registered in the Eindhoven Cancer Registry (ECR), received a questionnaire including patients' follow-up care consumption, preferences regarding the follow-up schedule, HRQL (SF36 and EORTC-QLQ-EN24), and worry (IOCv2). RESULTS: 742 (77%) endometrial cancer survivors returned a completed questionnaire. Overall, 19% reported receiving more follow-up visits than recommended by the guidelines. Overconsumption of follow-up care was lowest in follow-up year 1 (13%), and highest in follow-up years 6-10 (27%). In addition, overconsumption was associated with having a comorbid condition, a higher score on the worry subscale, and hospital of treatment. Most patients (83%) felt comfortable with their follow-up schedule. Patients in follow-up years 6-10 felt least comfortable (69%). CONCLUSION: Follow-up frequency was higher than recommended in a large group of endometrial cancer survivors, mainly in follow-up years 6-10. Moreover, a substantial variation in follow-up practice was observed between the different hospitals. Despite limited evidence to support the use of intensive follow-up schedules, the current study suggests that intensive routine follow-up after endometrial cancer continues to be standard practice. Possibly, patients should be better informed in order to reduce overconsumption and worry.

The relationship of body mass index with quality of life among endometrial cancer survivors: a study from the population-based PROFILES registry.

OBJECTIVE: The aim of the study was to assess the association of body mass index (BMI) and Health-Related Quality of Life (HRQoL), and the relative importance of BMI in explaining variation in QoL among stage I or II endometrial cancer (EC), independent of comorbidities, socio-demographic and clinical characteristics. METHODS: A population-based, cross-sectional survey was conducted in 2008 among endometrial cancer survivors diagnosed between 1999 and 2007 sampled from the Eindhoven Cancer Registry. The HRQoL (SF-36), EC specific HRQoL (EORTC-QLQ-EN24), comorbidities (SCQ) and fatigue (FAS) questionnaire were completed by 666 endometrioid EC survivors. Multivariate regression analyses were used to assess the associations of HRQoL with BMI reported at time of questionnaire completion and to assess the percentage of variance in HRQoL outcomes explained by BMI (R(2)), (controlled for socio-demographic and clinical characteristics and comorbidity). RESULTS: Of all women, 432 (67.6%) were pre-obese (BMI 25-30) or obese (BMI >30). Increased BMI was associated with decreased physical function, decreased vitality, more lymphoedema symptoms, decreased sexual/vaginal problems, less taste change and more fatigue symptoms. BMI added significantly to the explained variance of physical function (4.3%), physical limitations in daily life (role physical; 0.7%), bodily pain (1.5%), vitality (1.6%), emotional limitations in daily life (role emotional; 0.9%), lymphoedema symptoms (5.2%), sexual/vaginal problems (3.2%), urologic problems (0.7%), and fatigue (1.4%). CONCLUSION: BMI was related to several HRQoL outcomes. Therefore BMI needs to be taken into account in HRQoL studies. Moreover, future research should assess if interventions to decrease BMI in obese EC survivors might improve HRQoL.

Inspiration or deflation? Feeling similar or dissimilar to slim and plus-size models affects self-evaluation of restrained eaters.

The present studies examined the effect of perceiving images of slim and plus-size models on restrained eaters' self-evaluation. While previous research has found that such images can lead to either inspiration or deflation, we argue that these inconsistencies can be explained by differences in perceived similarity with the presented model. The results of two studies (ns=52 and 99) confirmed this and revealed that restrained eaters with high (low) perceived similarity to the model showed more positive (negative) self-evaluations when they viewed a slim model, compared to a plus-size model. In addition, Study 2 showed that inducing in participants a similarities mindset led to more positive self-evaluations after viewing a slim compared to a plus-size model, but only among restrained eaters with a relatively high BMI. These results are discussed in the context of research on social comparison processes and with regard to interventions for protection against the possible detrimental effects of media images.

The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial.

BACKGROUND: There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal document, and includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion. Until now, evidence on the effects of implementing the SCP in clinical practice is lacking. The rationale and study design of a pragmatic cluster randomized trial, aiming to assess the impact of SCP care in routine clinical practice, is presented. METHODS/DESIGN: A web-based patient registration system 'Registrationsystem Oncological GYnecology' (ROGY) is used by gynecologists in the South of the Netherlands since 2006. A personalized SCP can automatically be generated out of ROGY. In this pragmatic cluster randomized controlled trial, 12 hospitals are randomized to either 'usual care' or 'SCP care'. In patients with 'usual care', the gynecologist provides care as usual. In patients with 'SCP care', information about the tumor stage and treatment is personally discussed with the patient and a document is handed to the patient. Prospectively, all patients diagnosed with endometrial or ovarian cancer in the participating hospitals will be approached for study participation. Patients will complete questionnaires after surgery, and before additional treatment, and after 6, 12, 18 and 24 months. In addition, health care providers will be asked their opinion about implementation of SCP care. Primary outcome is defined as patient satisfaction with information provision and care. Secondary outcomes are illness perception, health-related quality of life, health care use, prevalence, course and referral rate of survivors with psychosocial distress, and health care providers' evaluation of SCP care. DISCUSSION: The ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors. TRIAL REGISTRATION: Trial Registration: http://www.ClinicalTrials.gov. Identifier: NCT01185626 Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743.