In the audit-phase, a group of 59 patients will be recruited and followed over a 12 month period. Data will be collected on clinical and patient outcomes in an audit in order to be able to compare to the intervention (after-phase) group.

In the pilot-phase, a group of 59 patients will be recruited and followed over a 6-12 month period. Patients in this group will be assigned to the new remote monitoring follow-up pathway (ePRIME), whereby instead of attending routine outpatient appointments they are monitored remoted via a online symptom monitoring questionnaire and related clinical tests undertaken remotely. All information is collated in the patient's electronic patient record, and clinicians will review/respond to the data as necessary.

ePRIME is an remote monitoring pathway that includes an online system for patients to self-report symptoms and AE following cancer treatments. ePRIME allows AE reporting from home and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for serious symptoms to the relevant clinical team and providing patient advice on managing mild and moderate symptoms.

ePRIME

Galina Velikova

Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed. This research project aims to develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission. The project includes a development phase, followed by an audit \& pilot intervention phase to explore the feasibility of a new pathway/system for remote monitoring.

Background Improvements in cancer treatment have led to an increasing number of patients being cured or in remission, but they are followed up to detect recurrence, manage persistent symptoms and late treatment effects. With growing survivors, traditional hospital follow-up is not sustainable. New models of follow-up care are needed.

Aim To develop and establish the feasibility of introducing a new electronic care pathway/system for remote monitoring ovarian cancer patients in remission.

Methods An existing online patient symptom reporting system will be extended for use in remote follow-up. A tracking program will be developed and IT systems integrated in the local hospitals.

Development Phase:

a) Scoping literature review of existing validated symptom measures. b) Consultation with expert groups to establish choice of questions, relevant symptoms, timing/frequency for monitoring. c) Interviews with patients and clinicians to explore current pathway and redesign.

Audit of usual care phase In this phase consecutive eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients (on completion of their first/second line of treatment) will be approached and data on clinical outcomes collected at the routine 3 monthly outpatient appointments for 12 months and PROMs collected 6 monthly. We aim to recruit around 60 patients.

Pilot Intervention phase In the intervention group the feasibility of the re-designed care pathway (intervention) will be piloted in a separate group of eligible ovarian, fallopian tube, primary peritoneal, endometrial or female genital (not otherwise specified) cancer patients. The patients approached will be a mixture of those who are entering follow-up after recently completing their first/second line treatment, and those who have already been attending for some time (months/years) for routine follow-up after their first/second line treatment. We aim to recruit around 60 patients. Consenting patients will be reminded to use the online system every 3 months and have a mandatory blood test by their GP/local hospital. Information will be available for the clinical teams to access electronically. Patients will always have the option to choose to speak or see their 'key clinician'. Virtual clinics will be held for key clinicians to review and respond to remote monitoring data. Clinical and patient outcomes will be collected for a 6-12 month period (this timeframe is dependent on the date of study entry and the funding period remaining). Following the pilot intervention period, 10 patients (or more if deemed necessary) and 6 clinicians will also be interviewed.

Outcomes

* Develop a new electronic care pathway/system for remote monitoring patients in remission
* Obtain initial data on clinical and patient feasibility.

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences

Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences: Implement the System for Remote Monitoring of Cancer Patients in Remission

Number of patients recruited and number of patients approached will be logged by research team during recruitment (including reasons for non-recruitment)

Number of participant withdrawals will be logged by research team at the time of any withdrawals

Reasons for withdrawal will be assessed via case record form completed by researcher with the participant at time of withdrawal and collated at the end of the study

Patients will be reminded to complete an electronic questionnaire about their symptoms at 3 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 6 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 9 months

Patients will be reminded to complete an electronic questionnaire about their symptoms at 12 months

Patient acceptability explored through end-of-study questionnaires and interviews

Clinician acceptability explored through end-of-study questionnaires and interviews

Yorkshire Cancer Research

The Leeds Teaching Hospitals NHS Trust

Bradford Teaching Hospitals NHS Foundation Trust

Calderdale and Huddersfield NHS Foundation Trust

Airedale NHS Foundation Trust

University of Leeds

Professor of Psycho-social and Medical Oncology/Consultant in Medical Oncology

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants who are included during care as usual, before the hospital's transition to personalized follow-up. Care as usual is organized as 'one-size fits all' and does not take individual differences in prognoses and needs into account. For the majority of hospitals follow-up includes annual mammography and physical examination combined with discussing of the results of the mammogram and sometimes also the patient's needs.

Participants who are included after the hospital's transition to personalized follow-up. After this transition, personalized follow-up becomes the standard form of care for all patients, regardless of their participation in this study. Participants of this group receive personalized follow-up, which is based on individual prognoses and needs. Personalized follow-up will be provided by the use of personalized surveillance (PSP) and personalized aftercare plans (PAP).

The PSP contains decisions on the surveillance trajectory based on individual risks and needs, assessed with the 'Breast Cancer Surveillance Decision Aid' including the INFLUENCE prediction tool. The PAP contains decisions on the aftercare trajectory based on individual needs and preferences and available care resources, which decision-making is supported by a patient decision aid.

personalized surveillance plans (PSP) and personalized aftercare plans (PAP)

Sabine Siesling

Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up.

The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)'. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients' need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated.

Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR).

The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care.

In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.

1. Treatment of subjects: personalized follow-up Personalized Surveillance Plan (PSP): Around the first surveillance mammogram (i.e. one year after end of treatment), the personalized surveillance plan (PSP) is generated by means of the PSP decision aid, called the 'Breast Cancer Surveillance Decision Aid' (16). This Aid incorporates the INFLUENCE tool 3.0, which is a sequel of the INFLUENCE tool 2.0 (15) and will be developed during this project. Compared to INFLUENCE 2.0, INFLUENCE 3.0 will additionally include patients treated with neoadjuvant therapy a broader population than INFLUENCE 2.0 (including patients treated with neoadjuvant therapy) and will include a more recent population in order to provide more contemporary risk estimates that are applicable in a broader population. During an outpatient clinic visit, around the first surveillance mammogram (i.e. approximately one year after the diagnosis), the INFLUENCE 3.0 prediction tool, as part of the PSP decision aid, is completed by the HCP (i.e. surgical oncologist or nurse specialist) and patient together by filling in data on patient, tumour and treatment characteristics. The estimated personal risk will be explained to the patient and summarized on a leaflet that also outlines the options possible for the patient (e.g. annual mammogram or less frequent, duration of follow-up, how to deliver the result from the mammogram). The patient receives a personal account with which she can, at home, complete the PSP decision aid that provides information about different surveillance options and a value clarification exercise to help the patient to get insight in her personal needs and preferences. This helps the patient to consider the pros and cons of the different options. A summary sheet based on patients' answers, combined with the result of the first surveillance mammogram, is used in the next consultation to make shared decisions on a personalized surveillance plan (PSP).

   Personalized Aftercare Plan (PAP): To support creation of this PAP, a patient decision aid (PtDA) will be used, which assesses patients' needs, offers information and provides a summary of patients' needs and preferences regarding the aftercare trajectory. The content of this PtDA will be developed in five cocreation sessions with a multidisciplinary team of researchers, patient representatives and care providers. First, needs assessment studies among patients and care providers will be conducted, which results serve as input for the content of the PtDA. This content will be critically revised by the team and rewritten to B1 language level (Common European Framework of Reference for Languages). Usability will be tested, consisting of think-aloud sessions with patients and interviews by telephone among health care professionals.

   During aftercare consultation(s) in the first year after the end of patients' treatment, the HCP (i.e. nurse or nurse specialist) will introduce the PtDA to the patient. Next, patients access the online PtDA to complete a needs assessment and receive information about possible effects of breast cancer, available options and choices that she has concerning her aftercare trajectory and available resources for help and support. Patients can weigh options and fill in preferences and considerations. Once patients have completed the PtDA, a summary sheet will automatically be created, containing an overview of patient-reported needs, preferences and considerations, which can be used as a base for final decision-making on the PAP in a consultation with their care provider. These decisions will compose the PAP, which will most likely include decisions on organisation of aftercare (e.g. further support or referrals, mode of contact, involved care providers) and signals to seek care for and contact details. Since patients' needs may vary over time, the care provider can introduce the PtDA multiple times during the aftercare trajectory. Also the PAP might be re-evaluated and adapted during the aftercare trajectory, depending on patients' needs and arranged contact frequencies.
2. Sample size calculation: The sample size was estimated using a user-written script for mITS designs in the Statistical Analysis System (SAS) software program. Since there are two primary parameters, a Bonferroni correction will be used to correct for multiple testing and therefore set the statistical significance level at alpha=0.025 (two sided). The effects the investigators wish to measure are a difference of 1.52 on the Cancer Worry Scale (CWS; range 6-24) and a difference of 4.8 on the EQ-VAS score (range 0-100), which is part of the EQ-5D. This decision is based on the aim to detect a small to moderate difference of 0.4 times the standard deviation, which was found to be around 3.8 for the CWS and 12 for the EQ-VAS score in previous studies. From a clinical point of view, a difference of 1.52 on the CWS is relevant for the purpose to estimate the effectiveness of personalized follow-up: even a small decrease in cancer worry can lead to improved quality of life. A difference of 4.8 on the VAS score is considered to be clinically relevant as well. A correlation is expected between the first two measurements within one hospital of 80%, and this correlation is expected to drop to 50% when comparing the first with the last measurement. In addition, an intraclass correlation coefficient of 0.15 is assumed. Taken 25% loss-to-follow up into consideration, each hospital will have to include four patients per period of three weeks in order to detect a difference of 1.52 on the CWS and 4.8 on the VAS score with 84%. The total inclusion time per hospital is 26 periods (78 weeks, or approximately 18 months), which amounts to a number of 104 patients per hospital and a study population of N=1,040.
3. Statistical analyses: An overview of the demographic and clinical characteristics will be provided using descriptive statistics. Continuous data will be expressed as a mean with the standard deviation (SD), or the Interquartile range (IQR) where appropriate. Categorical data will be expressed as frequencies (%). All questionnaires will be analysed in accordance with their corresponding manual. Self-composed questions (i.e. perceived risk of recurrence, adjusted questions from the CQ-Breast Index, demographics) will be analysed per item.

   To assess the effectiveness of personalized surveillance and aftercare, all outcome parameters will be compared between the current-care and personalized-care groups. Time series patterns will be visualized pre- and post-personalization to assess possible change in pattern after implementation of the personalization, for each hospital separately and combined. In this way the investigators can identify any underlying trends, seasonal patterns and outliers.

   To test the change in level and slope associated with the personalization and to control for other (confounding and overall trend) effects, segmented regression analyses will be used in which piecewise regression lines are fitted to each segment of time series, allowing each segment to exhibit different trends. To correct for correlation between repeated measurements residual plots against time will be visually examined, which can additionally be statistically tested using the Durbin-Watson statistic. Autocorrelation will consequently be adjusted for by including the autocorrelation parameter in the segmented regression model. Intention-to-treat analyses are done to estimate the effectiveness of personalized follow-up on the outcomes of the questionnaires. The Bonferroni correction will be used to adjust for multiple testing.

   Patients included during the transition phase will be analysed as receiving current care or personalized care dependent on whether PSP and PAP was applied. Sensitivity analyses will be performed with and without the patients included during the transition period, since there may be differences between care provided during and after the transition phase.

   In case of missing data, the investigators will record the percentage of drop-out and missing at each follow-up timepoint. If necessary, multiple imputation (if the assumptions for this technique are met) will be performed to ensure accurate analysis. Thereafter, meta-analyses will be performed to evaluate the average intervention effect per patient group across all hospitals and the overall effect across all patient groups and hospitals.

   A cost-effectiveness and cost-utility analysis will be performed comparing costs and effects of "personalized follow-up care" versus "usual care", using a two-year (study-based; based on data from the current study) and lifetime (model-based; based on the study and extrapolations by means of data from literature) time horizon. Information will be derived on the impact on personalized follow-up care on cancer worries, QoL, healthcare costs and (shift in) resources.

   Direct healthcare costs based on activities extracted from the EHRs (e.g. number of mammograms, consultations) will be multiplied by costs described in 'Benchmark costs from the Netherlands' or from the 'Nederlandse Zorgautoriteit' (NZa). For the costs of the interventions (decision support tools), an activity-based costing method will be performed for development, use and maintenance of the decision support platforms. Indirect costs that will be taken into consideration are healthcare consumption outside the hospital and health-related productivity losses. Productivity losses will be calculated by means of the Friction cost method, according to the International Society of Pharmaco-economical Organization and Research (ISPOR) guidelines.

   The cost-effectiveness will be expressed in incremental costs per patient with a clinically relevant improvement on the CWS as primary outcome of the NABOR study. The cost-utility will be expressed in incremental costs per quality adjusted life years (QALYs) gained, obtained from the EQ-5D-5L (including the VAS). Long term consequences will be based on both the study results and literature to extrapolate the patient outcomes for a lifelong time horizon.

   The cost-effectiveness analysis will be performed according to the guidelines for economic evaluations of the Dutch Zorginstituut (ZIN).
4. Handling of data

Data sources for our study:

* NCR (Netherlands Cancer Registry): data (e.g. patient-, tumor- and treatment-related characteristics) are already gathered and part of the general data collection of the NCR
* Additional patient data from the EHR: collected during the project
* PROFILES: a data registry collecting answers on questionnaires during the project Handling of data: For obtaining the data form the NCR, additional patient data from the EHR and answers on questionnaires through PROFILES, the study participants will provide Informed Consent. Registration will be done by the PROFILES registry. In order to send questionnaires to participants, participants will be asked permission for registration of their name and email-address or postal address in the PROFILES registry. In order to combine answers on questionnaires with data from NCR and the EHR later on, the PROFILES registry also needs their patient number and date of birth. Participants will also be asked permission for registration of their patient number and date of birth in the PROFILES registry. After the patient signs Informed Consent, the HCP will register the patient in PROFILES. HCPs can obtain the personal data and sequence number in the PROFILES registry, but have no access to the answers on questionnaires.

Accessibility of data: All the collected data is patient data, this cannot be made publicly available. Data from the NCR and additional EHR data can be requested, a local privacy committee evaluates requests. PROFILES data (i.e. answers on questionnaires) can be requested as well, and linked to NCR data if needed.

Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer

Effectiveness of persoNalized Care After Treatment for Nonmetastasized Breast Cancer Based On Risk of Recurrence, Personal Needs and Risk on (Late) Health Effects: the NABOR Study

Set of Brief Screening Questions (SBSQ); An average score of ≤2 indicates inadequate health literacy, and a score \>2 indicates adequate health literacy

Mental Adjustment to Cancer scale (MAC); higher scores represent greater severity of the behaviors in the patient's struggle with cancer

Performance of imaging (i.e. conclusion of imaging, breast density) and pathology (i.e. type of biopsies, cytology, histology), detected recurrences

Information on frequency and reason of breast cancer-related hospital visits. This also includes (if applicable): information on decisions made about aftercare and surveillance, whether prediciton models or decision aids are used and whether aftercare and survaillance plans are personalized.

Tumour- and treatment-related characteristics, like tumour and nodal stage, differentiation grade, receptor status, radiotherapy, systemic therapy, targeted therapy, possible recurrences.

Cancer Worry Scale (CWS); Range 6-24, higher scores indicate greater worrying

EQ-VAS (visual analogue scale of the EQ-5D); Range 0-100, higher scores indicate greater health-related quality of life

Quality of life questionnaire (EQ-5D-5L); higher score indicate better quality of life

Short-Form health index (SF-12); higher scores indicate greater quality of life

European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC-QLQ-C30); higher scores indicate better health-related quality of life

iMTA Productivity Cost Questionnaire (iPCQ); measures absence from work, reduced productivity while at work and productivity losses related to unpaid work

iMTA Medical Consumption Questionnaire (iMCQ); measures frequency of visits to health care practitioners outside the hospital and the extent to which others needed to join the patient in going to these visits, and the use of home care and medication

Self-composed questionnaire on perceived risk of recurrence, measuring perceived absolute and comparative risk, perceived comparative risk and perceived course of the risk over time

Shared Decision-Making Questionnaire (SDM-Q-9); range 0-45, higher scores indicate a greater level of perceived involvement in decision-making

Control Preference Scale (CPS); assesses the patient's preferred and perceived degree of control when decisions about treatment are being made. Higher scores indicate a preference for higher level of control in decision making

Consumer Quality breast care (CQ-breast index); higher scores indicate a greater satisfaction

Lubben Social Network Scale (LSNS); higher scores indicate greater social engagement

Questionnaire as composed by Luigjes-Huizer and colleagues, assesses the need for and experiences with support for fear of cancer recurrence

University of Twente

Dutch Breast Cancer Association

Borstkanker Onderzoek Groep

Netherlands Institute for Health Services Research

Comprehensive Cancer Centre The Netherlands

Senior researcher, full professor

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Participants in the experimental arm are enrolled in a patient-led follow-up program, based on patient-education and self-referral, in addition to recommendations from national guidelines for follow-up.

Participants in this control group follow standard care for follow-up after rectal cancer treatment, as described in local and national guidelines.

1. Patient-education, with information about signs of recurrent disease (alarm-symptoms), potential late effects, and how these can be managed.
2. The patients are instructed to contact a specialist nurse in case of alarm-symptoms, concerns or other problems related to the cancer disease throughout the entire follow-up period. The specialist nurse responds to the referrals, according to a standardized algorithm.

In addition, all patients receive:

* CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery
* perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years

Only for patients with a stoma:

- access to stoma care by specialist nurses

Patient-led follow-up

Patients with sphincter-preserving resection:

- outpatient visits incl. rectoscopy at 6, 12, 18, 24 and 36 months

Patients with rectal amputation and a permanent stoma:

* outpatient visits at 3, 12 and 36 months
* access to stoma care by specialist nurses

All patients:

* CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery
* perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years

Standard follow-up

Søren Laurberg, Prof. Dr.Med

With an increasing number of rectal cancer (RC) survivors, we see a rising attention to the late adverse effects following treatment of RC.

Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. The current follow-up program primarily focuses on detection of recurrence, with less attention to late adverse effects.

In a patient-led follow-up program, the surveillance for recurrent disease is combined with detection and treatment of late adverse effects and supportive survivorship care. The follow-up involves a high degree of patient-involvement, aiming at meeting the individual patient's needs.

The patient-led follow-up programme is based on a standardized patient-education in order to enforce the patients to assess and respond sufficiently to symptoms and health problems. In case of symptoms and concerns, the patients are instructed to consult a health professional for adequate assistance and intervention.

The intervention is tested in a multicenter randomized trial, comparing the patient-led follow-up to standard routine follow-up, involving prescheduled outpatient visits.

Recruitment:

Patients are included from colorectal surgical departments in Aarhus, Randers, Herning and Aalborg. These centres cover one third of all Danish rectal cancer patients.

Patients are approached at the postoperative visit in the outpatient clinic where they are presented for the pathology results, approximately 2 weeks after primary surgery. The doctor provides short oral information about the study and hand out written information.

Following that, a research nurse makes contact with the patient by telephone a few days later, in order to clarify whether the patient wants to participate or not. Participation requires written informed consent and baseline information from the patient prior to randomisation.

Sample size:

An initial estimation of sample size showed, that a total of 334 participants were needed in order to obtain statistically significant results (alpha 0.05, beta 0.20, SD 13, minimally important difference 4 points on the TOI-score). The assumed standard deviation (SD) used for this estimation was based on studies where setting and populations differ substantially from ours.

Therefore, an interim analysis of the main-outcome (Trial Outcome Index - TOI) has been performed in order to determine a more precise SD. In an updated sample size estimation, the following preconditions are listed: 10.4 SD, 0.05 alpha-value, 0.20 beta-value, an expected difference of 4 points on the TOI-scale and an expected total drop-out of 30%.

Furthermore, additionally 15% are added to the sample size, due to the assumption that the outcome data will be non-parametric. Thus the conclusion from the updated sample size estimation is that a total of 324 participants are needed in order to obtain statistically significant results.

Drop-out is defined by: verified metachronous recurrence, metastasis or other primary cancer, death, emigration from the participating regions or if a participant leaves the study.

Data:

Most data is collected using questionnaires, administered by the patient (Patient-reported outcome measures -PROM's).

Patients are asked to complete a questionnaire at baseline (time of inclusion), and then at 12 and 36 months after surgery. The questionnaires consists of questions regarding symptom burden and quality of life, specific symptoms, patient activation, self-efficacy, patient involvement, patient information and needs in the follow-up period, and how they have been met by the Health care system.

Data regarding recurrence of cancer and mortality is collected from the Medical charts, while data regarding socioeconomic factors is derived from national registers and data on comorbidity is extracted from the national clinical database for colorectal cancer surgery.

Finally, data on health care utilisation in the follow-up period will be collected from national registers, in combination with information from patient records (limited access).

Statistical analysis:

Outcomes will be analyzed using methods for repeated measurements, and survival analysis. Any difference between the two allocation groups will be significance tested, and adjusted for covariates, using multiple regression analysis.

Differences in demographics between the two groups will be calculated and significance tested using a chi2-test (dichotomous and categorical data) and t-test (numerical data).

Quality-adjusted life years will be calculated using standard health economic methods and in collaboration with an expert in health economics.

Study timeline:

Development of the intervention was performed during the second half of 2015. Inclusion of patients in the RCT was initiated in February 2016, and is expected to be complete by the 31st of July 2018.

With a three-year follow-up period, the final results from the study will be analyzed and ready for publication by the end of 2021.

Ethical considerations:

The risks and ethical concerns related to the project are limited, but there are some potential concerns. Removing routine follow-up could lead to a delay in detecting asymptomatic local recurrences. However, patients having symptoms with the opportunity of self-referral may get an earlier detection of recurrence.

Answering the questionnaire could remind participants about their disease and lead some patients to unpleasant or stressful situations.

Patients agreeing to participate should feel secure in whatever group they are randomized to follow.

The study follows the ethical principles in the Helsinki Declaration, and is reported and approved by The National Committee on Health Research Ethics as required.

Data is handled and stored, according to national law and only anonymised results will be published. The study is reported and approved by the Danish Data Protection Agency.

Participants are randomized (1:1) into either intervention or control group. This is done by block randomization, stratifying by center, sex and treatment type (± postoperative oncological treatment and ± temporary ileal stoma).

Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient

Full name: The Trial Outcome Index (TOI), which is a subscale within the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire.

Construct: The FACT-C measures health related quality of life. Five subscales can be derived from the questionnaire: physical wellbeing subscale, family/social wellbeing subscale, emotional well-being subscale, functional well-being subscale and a colorectal cancer-specific subscale. The TOI combines the physical, functional and cancer-specific subscales, which are considered likely to change by an intervention being tested.

Scale range (minimum and maximum scores): 0-84

Which values are considered to be a better or worse outcome: The higher the score, the better the QOL.

Indicate how subscales are combined (summed, averaged etc.): The TOI is calculated by summing the scores from the physical, functional and colorectal cancer-specific subscales.

Full name: The Low Anterior Resection Syndrome Score (LARS-score).

Construct: Assessment of bowel dysfunction following a low anterior resection for rectal cancer

Scale range (minimum and maximum scores): 0-42

Which values are considered to be a better or worse outcome: The higher the score, the more severe symptoms of bowel dysfunction

Indicate how subscales are combined (summed, averaged etc.): no subscales are used.

Full name: The Bristol Stool Scale

Construct: Assessment tool of the form of human faeces, and classification into seven stool types.

Scale range (minimum and maximum scores): type 1-7

Which values are considered to be a better or worse outcome: Types 1 and 2 indicate constipation. Types 3 and 4 indicate the ideal stools. Type 5 indicates slight diarrhea. Types 6 and 7 indicate diarrhea.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used.

Full name: 'The colostomy impact score'.

Construct: measures impact from colostomy dysfunction on quality of life

Scale range (minimum and maximum scores): The colostomy impact score ranges from 0 to 38 points.

Which values are considered to be a better or worse outcome: A score of ≥ 10 indicates major colostomy impact.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used

Full name: 'The male/female lower urinary tract symptoms' (ICIQ-FLUTS/ICIQ-MLUTS)

Construct: Evaluates male/female lower urinary tract symptoms and impact on quality of life

Scale range (minimum and maximum scores): The ICIQ-FLUTS It is scored on a scale from 0-16 for symptoms of filling, 0-12 for voiding symptoms and 0-20 for incontinence symptoms. Range of the total score is 0-48. The ICIQ-MLUTS is scored on a scale from 0-20 for voiding symptoms and 0-24 for incontinence symptoms. The range of the total score is 0-44.

Which values are considered to be a better or worse outcome: Higher scores indicate greater impact of individual symptoms for the patient

Indicate how subscales are combined (summed, averaged etc.): For both the ICIQ-FLUTS and the ICIQ-MLUTS, the total score is calculated by summing the scores from the subscales.

Full name: 'The Sexual Function - Vaginal Changes Questionnaire' (SVQ)

Construct: measures sexual and vaginal problems in gynaecological cancer, although it is assumed that rectal cancer patients experience similar problems due to changes in pelvic physiology and in the nervous innervation.

Scale range (minimum and maximum scores): The measure includes 20 core-items and 7 change-items. Out of these, 13 questions are only filled-out if the responder is sexually active. A total score will not be reported. Items 1-3 and 21-23 are combined into a subscale evaluating sexual interest and relations, with a range from 6-21.

Which values are considered to be a better or worse outcome: Higher values indicate better outcome

Indicate how subscales are combined (summed, averaged etc.): The subscale for sexual interest and relations is calculated by summing the scores from the items 1-3 and 21-23.

Full name: 'The International Index for Erectile Function' (IIEF) for males.

Construct: measures the effects from erection problems on sex life

Scale range (minimum and maximum scores): 6-75

Which values are considered to be a better or worse outcome: higher scores indicate better outcome.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used

Full name: 'The Chronic Pain Score after Rectal Cancer Treatment'

Construct: The score measures chronic pain in the pelvic area following treatment for rectal cancer.

Scale range (minimum and maximum scores): 0 to 46 points.

Which values are considered to be a better or worse outcome: Scores from 0-4 indicate no pain; 5-20 indicate minor pain; ≥ 21 indicate major pain

Indicate how subscales are combined (summed, averaged etc.): No subscales are used

Full name: The Multidimensional Fatigue Inventory (MFI-20)

Construct: evaluates ﬁve dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.

Scale range (minimum and maximum scores): 20-100

Which values are considered to be a better or worse outcome: Higher total scores correspond with more acute levels of fatigue.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used

Full name: The Fear of Cancer Recurrence Inventory (FCRI)

Construct: multidimensional measure for fear of recurring cancer. Includes seven subscales, of which one (severity subscale) is considered a short-form subscale.

Scale range (minimum and maximum scores): 0-168

Which values are considered to be a better or worse outcome: higher values indicate worse outcome

Indicate how subscales are combined (summed, averaged etc.): The short-form subscale is calculated by summing values from items 9-17. The total score is summed by all item values.

Full name: 'The Hospital Anxiety and Depression Scale' (HADS)

Construct: measures anxiety and depression in a general medical population of patients

Scale range (minimum and maximum scores): 0-21

Which values are considered to be a better or worse outcome: Scores of 0-7 are considered normal, 8-10 borderline and 11 or over indicate clinical 'caseness'.

Indicate how subscales are combined (summed, averaged etc.): The score is divided into a depression scale and an anxiety scale - both scales range from 0-21.

Full name: The patient activation measure (PAM)

Construct: measures the patient's knowledge, skills and confidence for self-management.

Scale range (minimum and maximum scores): The 13 items have a calibrated scale range from 38.6 to 53.0 (on a theoretical 0-100 point scale)

Which values are considered to be a better or worse outcome: PAM segments people into one of four progressively higher levels of activation.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used.

Full name: Patient involvement

Construct: measures the patient's experience of being involved by health care professionals during follow-up

Scale range (minimum and maximum scores): 6-60

Which values are considered to be a better or worse outcome: higher scores indicate better outcome.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used

Full name: Patient information and sense of security

Construct: measures the patient's experience of receiving adequate information and help during follow-up

Scale range (minimum and maximum scores): 5-25

Which values are considered to be a better or worse outcome: higher scores indicate worse outcome.

Indicate how subscales are combined (summed, averaged etc.): no subscales are used

QALY's derived from 'The EuroQol 5-dimensional health state measurement'. Data from national health care registries are also utilised

Danish Cancer Society

Herning Hospital

Aalborg University Hospital

Randers Regional Hospital

Aarhus University Hospital

PhD-student, registered nurse

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.

Questionnaires

Karen S Jensen, MD

The aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. It is relevant when new follow-up programs are to be designed.

More than 90 % of paediatric patients with acute lymphoblastic leukaemia (ALL), treated on the Nordic Society of Pediatric Hematology and Oncology (NOPHO) ALL-2008 protocol, are alive five years after diagnosis. The main reason for treatment failure being relapse.

The risk of relapse after treatment for ALL is highest within the first two years after cessation of maintenance therapy. Therefore, it has been routine in most countries to follow-up patients in the outpatient clinic every one or two months during the first years after end of therapy for ALL in order to detect recurrence and possible late sequelae at an early stage.

In children with ALL there are only a few studies on the value of routine follow-up, including haematological status after cessation of maintenance therapy. These studies showed that approximately 90% of the relapses were diagnosed in children with symptoms of leukaemia progression and that routine blood tests and clinical follow-ups were of little value. It is well known that there are other issues besides the risk of relapse, which are relevant for families after cessation of ALL therapy i.e. risk of late effects of treatment, psychosocial problems related to the child's return to "normal" life etc. These issues will also have an impact upon how the follow-up programs are planned. The investigators will study the family perspectives on follow-up during the first 5-years after cessation of maintenance therapy in a Danish cohort of children treated according to the NOPHO ALL-2008 protocol.

The investigators will conduct a cross-sectional study. Outcomes are patient-reported as the measurement instrument used is questionnaires. Eligible families are families with children diagnosed with acute lymphoblastic leukaemia in Denmark and being in the period 0-5 years after cessation of maintenance therapy.

The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items.

An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome.

An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome.

Self-designed questionnaire. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome.

Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life.

Self-designed questionnaire. Fifteen items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the fifteen items.

An item evaluating the duration of the time period before the child was able to attend day-care/school on a scale 1-5. Higher values represent a worse outcome.

Self-designed questionnaire. In need of advice between visits what are the strategy of the participants: seeking hospital, general practitioner or postponing till next scheduled visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences	NCT02847715	Cancer	ePRIME	18 Years -	University of Leeds
Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer	NCT05975437	Breast Cancer Breast Cancer F... Survivorship	personalized su...	40 Years -	Comprehensive Cancer Centre The Netherlands
Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer	NCT05975437	Breast Cancer Breast Cancer F... Survivorship	personalized su...	40 Years -	Comprehensive Cancer Centre The Netherlands
Electronic Patient Self-Reported Outcomes to Improve Cancer Management and Patient Experiences	NCT02847715	Cancer	ePRIME	18 Years -	University of Leeds
Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient	NCT03622437	Rectal Neoplasm...	Patient-led fol... Standard follow...	18 Years -	Aarhus University Hospital
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives	NCT03985215	Precursor Cell ... Surveys and Que...	Questionnaires	1 Year - 15 Years	University of Aarhus
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives	NCT03985215	Precursor Cell ... Surveys and Que...	Questionnaires	1 Year - 15 Years	University of Aarhus

Spots Global Cancer Trial Database for aftercare

Every month we try and update this database with for aftercare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aftercare

Every month we try and update this database with for aftercare cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aftercare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.