Symptoms and seeking supportive care and associations with quality of life after treatment for colon cancer: Results from the I CARE cohort study.

OBJECTIVE: Patients treated for colon cancer report many symptoms that affect quality of life (QoL). Survivorship care aims at QoL improvement. In this study, we assess associations between symptoms and seeking supportive care and lower QoL and QoL changes overtime during survivorship care. METHODS: A prospective cohort of colon cancer survivors. Questionnaires are administered at inclusion and 6 months later to evaluate symptoms, functioning and seeking supportive care including associations with QoL, using the EORTC QLQ-C30. RESULTS: The mean QoL score at the first questionnaire was 82 (scale 1-100), which improved over time. Pain, bowel symptoms and problems in physical, role, cognitive or social functioning are associated with lower QoL at inclusion but are not associated with QoL changes over time. Seeking support for lower bowel symptoms, physical functioning or fatigue is associated with lower QoL. After 6 months, seeking support for upper bowel symptoms or physical functioning is associated with a tendency towards less QoL improvement. CONCLUSION: QoL of colon cancer survivors improves over 6 months, but seeking support for specific symptoms barely contribute to this improvement. IMPLICATIONS: This study confirms the importance of addressing symptoms, problems related to functioning and seeking supportive care during survivorship care.

Effect of general practitioner-led versus surgeon-led colon cancer survivorship care, with or without eHealth support, on quality of life (I CARE): an interim analysis of 1-year results of a randomised, controlled trial.

BACKGROUND: Colon cancer is associated with an increased risk of physical and psychosocial morbidity, even after treatment. General practitioner (GP) care could be beneficial to help to reduce this morbidity. We aimed to assess quality of life (QOL) in patients who received GP-led survivorship care after treatment for colon cancer compared with those who received surgeon-led care. Furthermore, the effect of an eHealth app (Oncokompas) on QOL was assessed in both patient groups. METHODS: We did a pragmatic two-by-two factorial, open-label, randomised, controlled trial at eight hospitals in the Netherlands. Eligible patients were receiving primary surgical treatment for stage I-III colon cancer or rectosigmoid carcinoma and qualified for routine follow-up according to Dutch national guidelines. Patients were randomly assigned (1:1:1:1)-via computer-generated variable block randomisation stratified by age and tumour stage-to survivorship care overseen by a surgeon, survivorship care overseen by a surgeon with access to Oncokompas, survivorship care overseen by a GP, or survivorship care overseen by a GP with access to Oncokompas. Blinding of the trial was not possible. The primary endpoint of the trial was QOL at 5 years, as measured by the change from baseline in the European Organistion for Research and Treatment of Cancer QLQ-C30 summary score. Here, we report an unplanned interim analysis of QOL at the 12-month follow-up. Grouped comparisons were done (ie, both GP-led care groups were compared with both surgeon-led groups, and both Oncokompas groups were compared with both no Oncokompas groups). Differences in change of QOL between trial groups were estimated with linear mixed-effects models. A change of ten units was considered clinically meaningful. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR4860. FINDINGS: Between March 26, 2015, and Nov 21, 2018, 353 patients were enrolled and randomly assigned. There were 50 early withdrawals (27 patient decisions and 23 GP withdrawals). Of the remaining 303 participants, 79 were assigned to surgeon-led care, 83 to surgeon-led care with Oncokompas, 73 to GP-led care, and 68 to GP-led care with Oncokompas. Median follow-up was 12·2 months (IQR 12·0-13·0) in all groups. At baseline, QOL was high in all trial groups. At 12 months, there was no clinically meaningful difference in change from baseline in QOL between the GP-led care groups and the surgeon-led care groups (difference in summary score -2·3 [95% CI -5·0 to 0·4]) or between the Oncokompas and no Oncokompas groups (-0·1 [-2·8 to 2·6]). INTERPRETATION: In terms of QOL, GP-led survivorship care can be considered as an alternative to surgeon-led care within the first year after colon cancer treatment. Other outcomes, including patient and physician preferences, will be important for decisions about the type of survivorship care. FUNDING: Dutch Cancer Society (KWF).

General practitioners' involvement during survivorship care of colon cancer in the Netherlands: primary health care utilization during survivorship care of colon cancer, a prospective multicentre cohort study.

BACKGROUND: Primary health care use increases when cancer is diagnosed. This increase continues after cancer treatment. More generalist care is suggested to improve survivorship care. It is unknown to what extent cancer-related symptoms are currently presented in primary care in this survivorship phase. OBJECTIVE: To analyse primary health care utilization of colon cancer patients during and after treatment with curative intent. METHODS: In a prospective multicentre cohort study among patients with curatively treated colon cancer, we describe the primary health care utilization during the first 5 years of follow-up. Data were collected at general practitioner (GP) practices during 6 months. RESULTS: Of 183 included participants, 153 (84%) consulted their GP resulting in 606 contacts (mean 3.3, standard deviation 3.01) with on average 0.9 contact for colon-cancer-related (CCR) problems in the 6-month study period. Median time after surgery at inclusion was 7.6 months (range 0-58). Abdominal pain and chemotherapy-related problems were the most frequently reported CCR reasons. Of the CCR contacts, 83% was managed in primary care. As time after surgery passed, the number of CCR contacts declined in patients without chemotherapy and remained constant in patients who received chemotherapy. CONCLUSION: Colon cancer survivors contact their GP frequently also for reasons related to cancer. Currently, a formal role for GPs in survivorship care is lacking, but nevertheless GPs provide a substantial amount of care. Working agreements between primary and secondary care are necessary to formalize the GP's role in order to improve the quality of survivorship care.

Introducing a time out consultation with the general practitioner between diagnosis and start of colorectal cancer treatment: Patient-reported outcomes.

OBJECTIVE: To evaluate the introduction of a "time out consultation" with the general practitioner (GP) recommended to patients following the diagnosis of colorectal carcinoma (CRC) before start of treatment. METHODS: A prospective study using questionnaires to compare the number of GP consultations, with their content and outcomes before and after the introduction of an additional consultation with the GP to improve decision-making and adequate support. RESULTS: 72 patients before and 98 patients after the introduction of the "time out consultation" participated. Introduction of the consultation increased the number of patients to contact their GP from 67% to 80%, but did not change kind or content of the consultations. Patients felt the consultation was comforting and were more satisfied with the GP after the introduction. There was no difference in outcomes measured by the questionnaires in all patients combined, but men, older patients and patients with palliative treatment options only did improve on specific outcomes after the introduction. CONCLUSION: The introduction of the "time out consultation" did not change the kind or content of GP consultations before start of CRC treatment, but patients did feel more comforted and satisfied. Subgroups of patients benefited on specific outcomes.

Clinical Pattern of Recurrent Disease during the Follow-Up of Rectal Carcinoma.

BACKGROUND/AIMS: Several initiatives have started to transfer colorectal cancer follow-up (FU) from secondary to primary care. For this purpose, it is important to assess when and how recurrences of rectal carcinoma are detected after treatment with curative intent. METHODS: Retrospective multicentre cohort study. Patients participating in an FU programme after curative intended treatment for rectal cancer stages I-III between 2007 and 2014. RESULTS: Of the 378 patients, 64 (17%) developed recurrent disease (RD). Most were detected during scheduled FU consultations (n = 55) by (a combination of) radiological examinations and carcinoembryonic antigen levels, and were asymptomatic (n = 53); outside scheduled FU consultations, RD was detected during the treatment of postoperative complications or ostomy reversal (n = 5), or due to symptoms (n = 4). Most frequent sites of recurrence were liver (50%), lung (44%), multiple (22%) or locoregional (16%). Treatment of RD with curative intent was performed more frequently when detected during scheduled FU (60 vs. 22%). The only predictive factor for developing RD was stage III disease on initial presentation. CONCLUSIONS: The majority of rectal cancer patients are diagnosed with RD at an asymptomatic stage during scheduled FU consultations. Only a few patients presented with RD outside the FU programme. Arguably, general practitioners could order these same diagnostic tests during FU.

Need for general practitioner involvement and eHealth in colon cancer survivorship care: patients' perspectives.

Background: As colon cancer is increasingly becoming a chronic illness with a broad range of symptoms, there is a need for individually tailored care for these patients. Objective: To investigate patients' opinions about GP involvement in survivorship care and the use of eHealth applications, such as Oncokompas2.0, to support self-management. Oncokompas2.0 is an interactive website that monitors quality of life via participant-reported outcomes and provides feedback and personalized supportive care. Methods: We conducted a qualitative study using semi-structured interviews with patients diagnosed with stages I-III colon cancer treated with curative intent. Twenty participants (nine men, age range 49-86 years) were recruited in five Dutch hospitals by purposive sampling. Thematic data analysis was done by two coders. Results: Possible benefits of greater GP involvement include better accessibility of care and additional guidance. Participants considered an increased workload for the already busy GP as a disadvantage. Requirements for greater GP involvement were assurance of sufficient knowledge and expertise of the GP and easy access to secondary care. Most participants expected that Oncokompas2.0 would increase awareness of symptoms and concerns and provide more insight into support possibilities. Reservations mentioned were the expected loss of personal contact with health professionals and the feasibility of implementation in the total patient population. Conclusion: Colon cancer patients see some benefit of greater GP involvement and the use of Oncokompas2.0 to improve survivorship care. Our study results support initiatives to further explore GP-led survivorship care and the implementation of eHealth.

Diagnosis and prognosis of acute hamstring injuries in athletes.

PURPOSE: Identification of the most relevant diagnostic and prognostic factors of physical examination and imaging of hamstring injuries in (elite) athletes. METHODS: A literature search was conducted in MEDLINE and EMBASE for articles between 1950 and April 2011. A survey was distributed among the members of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy, which focused on physical examination, prognosis, imaging and laboratory tests of hamstring injuries in (elite) athletes. RESULTS: Medical history, inspection and palpation of the muscle bellies and imaging are most valuable at the initial assessment according to the literature. Experts considered medical history, posture and gait inspection, inspection and palpation of muscle bellies, range of motion tests, manual muscle testing, referred pain tests and imaging to be most important in the initial assessment of hamstring injuries. Magnetic resonance imaging (MRI) is preferred over ultrasonography and should take place within 3 days post-trauma. Important prognostic factors are injury grade, length of the muscle tear on MR images, MRI-negative injuries and trauma mechanism. CONCLUSIONS: Posture and gait inspection, inspection and palpation of muscle bellies, range of motion tests, manual muscle testing and referred pain tests within 2 days post-trauma were identified as the most relevant diagnostic factors. LEVEL OF EVIDENCE: Literature review and expert opinion, Level V.

Detection of colon cancer recurrences during follow-up care by general practitioners vs surgeons.

BACKGROUND: In the I CARE study, colon cancer patients were randomly assigned to receive follow-up care from either a general practitioner (GP) or a surgeon. Here, we address a secondary outcome, namely, detection of recurrences and effect on time to detection of transferring care from surgeon to GP. METHODS: Pattern, stage, and treatment of recurrences were described after 3 years. Time to event was defined as date of surgery, until date of recurrence or last follow-up, with death as competing event. Effects on time to recurrence and death were estimated as hazard ratios (HRs) using Cox regression. Restricted mean survival times were estimated. RESULTS: Of 303 patients, 141 were randomly assigned to the GP and 162 to the surgeon. Patients were male (67%) with a mean age of 68.0 (8.4) years. During follow-up, 46 recurrences were detected; 18 (13%) in the GP vs 28 (17%) in the surgeon group. Most recurrences were detected via abnormal follow-up tests (74%) and treated with curative intent (59%). Hazard ratio for recurrence was 0.75 (95% confidence interval [CI] = 0.41 to 1.36) in GP vs surgeon group. Patients in the GP group remained in the disease-free state slightly longer (2.76 vs 2.71 years). Of the patients, 38 died during follow-up; 15 (11%) in the GP vs 23 (14%) in the surgeon group. Of these, 21 (55%) deaths were related to colon cancer. There were no differences in overall deaths between the groups (HR = 0.76, 95% CI = 0.39 to 1.46). CONCLUSION: Follow-up provided by GPs vs surgeons leads to similar detection of recurrences. Also, no differences in mortality were found.

Cost-effectiveness of general practitioner- versus surgeon-led colon cancer survivorship care: an economic evaluation alongside a randomised controlled trial.

PURPOSE: The aim of this study is to assess cost-effectiveness of general practitioner (GP) versus surgeon-led colon cancer survivorship care from a societal perspective. METHODS: We performed an economic evaluation alongside the I CARE study, which included 303 cancer patients (stages I-III) who were randomised to survivorship care by a GP or surgeon. Questionnaires were administered at baseline, 3-, 6-, 12-, 24- and 36-months. Costs included healthcare costs (measured by iMTA MCQ) and lost productivity costs (SF-HLQ). Disease-specific quality of life (QoL) was measured using EORTC QLQ-C30 summary score and general QoL using EQ-5D-3L quality-adjusted life years (QALYs). Missing data were imputed. Incremental cost-effectiveness ratios (ICERs) were calculated to relate costs to effects on QoL. Statistical uncertainty was estimated using bootstrapping. RESULTS: Total societal costs of GP-led care were significantly lower compared to surgeon-led care (mean difference of - €3895; 95% CI - €6113; - €1712). Lost productivity was the main contributor to the difference in societal costs (- €3305; 95% CI - €5028; - €1739). The difference in QLQ-C30 summary score over time between groups was 1.33 (95% CI - 0.049; 3.15). The ICER for QLQ-C30 was - 2073, indicating that GP-led care is dominant over surgeon-led care. The difference in QALYs was - 0.021 (95% CI - 0.083; 0.040) resulting in an ICER of 129,164. CONCLUSIONS: GP-led care is likely to be cost-effective for disease-specific QoL, but not for general QoL. IMPLICATIONS FOR CANCER SURVIVORS: With a growing number of cancer survivors, GP-led survivorship care could help to alleviate some of the burden on more expensive secondary healthcare services.

Recruitment challenges to the I CARE study: a randomised trial on general practitioner-led colon cancer survivorship care.

OBJECTIVES: The I CARE study (Improving Care After colon canceR treatment in the Netherlands) aims to compare surgeon-led to general practitioner (GP)-led colon cancer survivorship care. Recruitment to the trial took longer than expected. In this descriptive study, recruitment is critically reviewed. SETTING: Patients were recruited from eight Dutch medical centres. PARTICIPANTS: Patients treated with curative intent for stages I-III colon cancer. Target patient sample size was calculated at 300. INTERVENTIONS: Patients were randomised to surgeon-led (usual) versus GP-led care, with or without access to an eHealth application (Oncokompas). OUTCOME MEASURES: Baseline characteristics of (non-)participants, reasons for non-participation and strategies to improve recruitment were reviewed. RESULTS: Out of 1238 eligible patients, 353 patients were included. Of these, 50 patients dropped out shortly after randomisation and before start of the intervention, resulting in a participation rate of 25%. Participants were on average slightly younger (68.1 years vs 69.3 years) and more often male (67% vs 50%) in comparison to non-participants. A total of 806 patients declined participation for reasons most often relating to research (57%), including the wish to remain in specialist care (31%) and too much effort to participate (12%). Some patients mentioned health (9%) and confrontation with the disease (5%) as a reason. In 43 cases, GPs declined participation, often related to the study objective, need for financial compensation and time restraints. The generally low participation rate led to concerns about reaching the target sample size. Methods to overcome recruitment challenges included changes to the original recruitment procedure and the addition of new study centres. CONCLUSIONS: Challenges were faced in the recruitment to a randomised trial on GP-led colon cancer survivorship care. Research on the transition of care requires sufficient time, funding and support base among patients and healthcare professionals. These findings will help inform researchers and policy-makers on the development of future practices. TRIAL REGISTRATION NUMBER: NTR4860.

Primary care-led survivorship care for patients with colon cancer and the use of eHealth: a qualitative study on perspectives of general practitioners.

OBJECTIVES: The aim of this study was to explore the perspectives of general practitioners (GPs) regarding their current and future role in survivorship care of patients with colon cancer, and to assess their perspectives on patients' self-management capacities and the value of the eHealth application Oncokompas(2.0) used by patients. SETTING: GPs from the central part of the Netherlands were interviewed at their location of preference. PARTICIPANTS: 20 GPs participated (10 men, 10 women, age range 34-65 years, median age 49.5 years). The median years of experience as a GP was 14.5 years (range 3-34 years). RESULTS: GPs indicated attempting to keep in contact with patients after colon cancer treatment and mentioned being aware of symptoms of recurrent disease. Most participants would have liked to be more involved and expected to be able to provide survivorship care of colon cancer. Requirements mentioned were agreements with secondary care and a protocol. GPs considered Oncokompas(2.0), which stimulates patients to structure their own survivorship care, as a useful additional tool for a specific group of patients (ie, young and highly-educated patients). CONCLUSIONS: Based on the perspectives of the GPs, survivorship care of colon cancer in primary care is deemed feasible and the use of an eHealth application such as Oncokompas(2.0) is expected to benefit specific groups of patients after colon cancer treatment.

Improving care after colon cancer treatment in The Netherlands, personalised care to enhance quality of life (I CARE study): study protocol for a randomised controlled trial.

BACKGROUND: It is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in The Netherlands. To date, patients are included in a surgeon-led follow-up programme whose main focus is recurrence detection. However, patients often experience multiple physical and psychosocial problems. Currently, these problems are not always encountered. More care by a generalist is suggested as a solution. Furthermore, patients prefer to undergo rehabilitation in their own environment and to be more involved in their own health care. eHealth applications might enhance this. Oncokompas(2.0) is an online self-management application which facilitates access to supportive care. This study aims to evaluate primary care follow-up and aftercare in comparison with secondary care follow-up and aftercare for patients with colon cancer. Second, the added value of Oncokompas(2.0) to care will be assessed. METHODS/DESIGN: This is a multi-centre 2 × 2 factorial randomised controlled trial with a calculated sample size of 300 patients. Patients with stage I, II, or III colon carcinoma are eligible. Patients will be randomly assigned in four groups: (1) usual follow-up visits and aftercare provided in secondary care, (2) usual follow-up visits and aftercare provided in secondary care with additional use of Oncokompas(2.0), (3) follow-up and aftercare in primary care, and (4) follow-up and aftercare in primary care with additional use of Oncokompas(2.0). The primary outcome is quality of life. Secondary outcomes include physical outcomes, psychosocial outcomes, number of investigations, referrals and related communication between secondary and primary care, (time of) recurrence detection and protocol adherence, attention to preventive care, self-management of patients, patient satisfaction, and preference of care at the end of the trial. Data collection will be done by questionnaires and extractions from electronic medical records. DISCUSSION: The results of this study will provide evidence, which has been scarce to date, on prominent general practitioner involvement in care for colon cancer patients after initial treatment. Also, it evaluates the efficacy of an eHealth application to enhance patient empowerment. DUTCH TRIAL REGISTER: NTR4860 (registered on 2 October 2014).