Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anne Tjønneland, MD PhD DMSc

Lars Kayser, MD PhD

This is an ethnographic study to investigate the competences and preferences in everyday living of men with prostate cancer, using participant observation and semi-structured interviews.

The study will work as the need assessment part of the emil project, which aims to design, develop, implement and evaluate a digital service to support a healthy lifestyle among men with prostate cancer.

Data was collected between June 2015 and April 2016. The data set included 4 parts; introducing interviews, participant observation, concluding interviews and questionnaires.

The introducing interview is conducted as a semi-structured interview with an interview guide. An informal approach is chosen to help along the report needed for the participant observation. The interview is recorded.

During participant observations, the participant is accompanied by the researcher, as he goes about his daily life. The researcher is participating in his activities to the extend it is possible, carrying out spontaneous informal interviews along the way taking cues from the situation, as is inherent to the participation of the researcher during participant observations. Field jottings are done discretely, during breaks in the observation or afterwards, on dictaphone or computer, in order to keep the relation informal, and not redirect the attention to the fact that they were being observed.

The concluding interview is performed as a natural ending of the collaboration between researcher and participant. It is performed as a semi-structured interview with an interview guide, and the central point is to confirm and elaborate on findings of the observation. The interview is recorded.

Pictures are taken of relevant artefacts or sceneries through all visits between participant and researcher, with the consent of the participants. Pictures are a part of the dataset on equal terms with observational notes and interview transcriptions.

In the questionnaire, baseline information such as educational level and self-rated health is gathered along with measurement of eHealth literacy (eHLQ) and health literacy (HLQ), both multidimensional validated psychometric instruments with seven and nine dimensions respectively, in order to relate the demography of this first study to the later studies of the emil project. The questionnaire is not used in the analysis of this study.

All data is collected before beginning familiarization and analysis of data.

Data analysis and interpretation The data set is analyzed using an inductive thematic analysis as described by Braun and Clarke (2006). All interviews and observations are conducted by the first author. Interviews, both introducing and concluding, are transcribed verbatim except for parts not included in the dataset, such as parts where the formal information about the study is given and written consent obtained or parts where practical arrangements are made.

All observational data are written together in one document from each visit. All pictures are included in the dataset. Familiarization with the data will be by listening and relistenning, reading and rereading through the dataset.

The thematic analysis will be performed by coding, processing and interpretation of data using the qualitative research software Nvivo11. Codes are re-read, discussed in the research group, re-coded and themed as outlined by the phases of Braun and Clarke, ending up with a thematic map.

Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior

Digitally Supporting Lifestyle Changes in Men With Prostate Cancer, Based on Characteristics and Needs - Part 1: Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior

It is a priority to protect the privacy of participant according to research ethics guidelines and GDPR. Participant data will only be shared in anonymized form and only in the extend demanded by a journal.

Factors will be identified by using Thematic analysis (Braun and Clarke, 2006) of ethnographic data, including interview transcriptions, observational notes, pictures and artefacts from the participant observation. All themes are based on identified categories and coding of observations, and are confirmed by supporting quotes.

The primary outcomes will be obtained in a way that it can inform the design process in the second study of the emil-project.

Digital capabilities and attitude will be examined as a specific part of the Thematic analysis (Braun and Clarke, 2006) of ethnographic data, including interview transcriptions, observational notes, pictures and artefacts from the participant observation. All themes are based on identified categories and coding of observations, and are confirmed by supporting quotes.

eHealth literacy evaluated by use of the eHealth Literacy questionnaire (eHLQ) and findings related to observed digital behavior.

University of Copenhagen

TrygFonden, Denmark

Danish Cancer Society

Ph.d. fellow, MD

Behaviors and Mental Disorders

Quality of Life

Amélie Anota, PhD

In oncology a number of supportive care therapies are proposed to patients. This study will identify the different therapies and prioritize these therapies from the patients' perspectives. This study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

In oncology, supportive care should be used along with curative treatment or palliative care in order to improve patients' health-related quality of life, overall survival and to better support treatment side effects as well as the disease evolution. Unfortunately, they are not widely used in clinical practice.

A direct assessment of the needs perceived unmet by patients could allow to assess the magnitude of expectations to better target treatments as example. A prospective assessment of the expectations and needs of the patients is thus essential. This would also allow help to highlight the convergence between supportive care proposed and used and those expected by patients. The first step to understanding how to optimize the use of resources and to improve the quality of care is to identify patient's expectations. Moreover, it is now well recognized that patients should play a key role in the research and that their active participation in research can increase the relevance of the research.

In this context, the CyPRES project aims to:

1. assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services;
2. prioritize them and to arrange resources according to priority needs identified;
3. identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. A randomized clinical trial will thus be proposed;
4. Involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Expectations and needs of the patients: completion of questionnaire N°1

Prioritize supportive care therapies: completion of questionnaire N°2 Expectations and needs of the patients questionnaire n°2 completed

Ligue contre le cancer, France

French National Platform Quality of Life and Cancer

Association Francophone des Soins Oncologiques de Support

UNICANCER

Symptoms and General Pathology

Rare Diseases

Recurrence

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Patients with recurrent high-grade glioma

Close relatives of patients with recurrent high-grade glioma

Frantz Rom Poulsen, Professor

This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care..

High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.

In this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.

Little is known about how the patients and their close relatives experience the recurrence and the decision-making process.

The objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.

Data will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.

The study is part of a larger PhD-study.

Treatment Decision-making in Patients With Recurrent High-grade Glioma

Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.

How patients and their close relatives experience the decision-making process

The preferences of patients and relatives for being involved in the decision-making.

Rigshospitalet, Denmark

Region of Southern Denmark

Novo Nordisk A/S

Odense University Hospital

Principal Investigator

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior	NCT03692585	Prostate Cancer Computer Litera... Health Behavior		40 Years -	Danish Cancer Society
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project	NCT03320161	Cancer Patients		18 Years -	UNICANCER
Treatment Decision-making in Patients With Recurrent High-grade Glioma	NCT04013828	Malignant Gliom... Life Experience...		18 Years -	Odense University Hospital
Treatment Decision-making in Patients With Recurrent High-grade Glioma	NCT04013828	Malignant Gliom... Life Experience...		18 Years -	Odense University Hospital
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
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project	NCT03320161	Cancer Patients		18 Years -	UNICANCER

Spots Global Cancer Trial Database for patient involvement