Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

The intervention group will receive face-to-face training, giving patient education booklet and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months.

CRCaSSM

Nazli Ozturk, MSC

Akdeniz University Hospital

Fatma Arikan

Objective: The aim of this study was to examine the effects of nursing interventions based on the symptom management model on symptom management, fear of recurrence, and quality of life in colorectal cancer survivors.

Method: The research was planned as a randomized controlled trial. The research is planned to be carried out at Akdeniz University Hospital. It is planned to be done with 52 patients, 26 experimental and 26 control groups. The intervention group will receive face-to-face training and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months. Participant Information Form, Memorial Symptom Assessment Scale, Fear of Cancer Recurrence Inventory and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale Scale will be used to collect data.

Colorectal Cancer Survivor Symptom Management

The Effect of Nursing Interventions Based on a Symptom Management Model on Symptom Management, Fear of Recurrence, and Quality of Life in Colorectal Cancer Survivors

Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.

Fear of Cancer Recurrence Inventory (FCRI): It consists of 42 items with seven subscales triggers, severity, psychological distress, coping strategies, functioning impairments, insight, reassurance. FCRI, is a Likert-type scale that ranges from 0 (not at all/never) to 4 (all the time/a great deal). Increasing scores received from the scale demonstrate a high level of FCR. The minimum score to be taken from the scale is 0, and the maximum score is 168.

EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.

EORTC QLQ-CR29 The QLQ-CR29 includes 29 items that evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others). Similar to the EORTC QLQ-C30, the QLQ-CR29 has a Likert scale of four response categories (item 48 requires a yes or no answer). All patient-rated scores are linearly converted into a scale from 0 to 100 for both the QLQ-C30 and QLQ-CR29.

Akdeniz University

Research Assistant

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Depressive Disorder

Depression

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Yeur-Hur Lai, Ph. D.

The lung cancer is the most has the life minacity in all kinds of cancers, and it also remains the most common cause of cancer-related death in the world. The group of lung cancer patients are suffer from huge disease impact that came from high mortality. Not only the course of treatment that patients has been diagnosis through operation is more faster, but also those who could be capable of operated are stabilized to keep follow-up at out-patient clinic. But in the next following five years after operation, they may take different dysfunctional level or some kinds of symptom distress. The effect has a great influence on those patients that have to face extended emotional impact, symptom distress and life style change. In addition, most of them concern about recurrent all the time in the remission. These situation needs us to place importance on it.

The purposes of this study are to investigate psychological and physical distress and care needs in operable lung cancer patients receiving surgery. This survey includes two parts of physical and mental condition. First, the investigators are scoring their symptom severity and quality of life to check physical condition. Seconded, the mental condition will use validated questionnaires to realize the relationship of anxiety, depression, uncertainty, fear of recurrence, self-efficacy and needs. Final, compare all of the data to patients' needs.

This study is a cross-sectional designs with convenience sampling that conform to the investigators recruited requirements. The investigators will recruit from the clinic of thoracic surgery in one medical center in Taipei and take five structured requirements. And the investigators are going to collect data from January, 2011 to December, 2012. Also expect results are lung cancer outpatients after surgery that more physical dysfunction or more depress of mental condition, it will lead patients' needs increased or significant difference. In conclusion, this study analyzes their needs in the remission that consequences can be medical professionals' reference material.

Inclusion Criteria:

lung cancer patients after surgery stage I, II and IIIA surgery for 3 months to 5 years over 20 years old

Exclusion Criteria:

lung cancer recurrence conscious unclear and do not know having cancer used to be treat (surgery, chemotherapy or radiotherapy) in 3 months. be uncomfortable or cooperate to fill the questionnaire.

Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery

National Taiwan University

National Taiwan University Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants in this experimental Arm 1 will receive the 3 group sessions followed by 4 to 5 individual coaching sessions via phone calls that last 60 minutes each.

Arm 2 will receive only the first 3 Life coach sessions (group session).

Arm 3 will receive routine care by the Breast clinic team for the entire course of the study.

Group coaching sessions will be focusing on providing material and tools that guide the participants in the transition from cancer treatment to survivorship. All activities of the group session will be following the "After Cancer Passport" document.

Group life-coaching

In the individual coaching sessions, the life-coach will provide guidances that help the participants to put tools into actions. All activities are outlined in the After Cancer Passport. Participants will use their Passport for each individual coaching session to outline their objectives and indicators of success. The life coach will also assign activities, such as self-reflection, for the participants to complete between each session.

Individual life-coaching

Sarkis Meterissian, M.D.

Sarkis Meterissian, Dr.

Sarkis Meterissian, DR

Virginia Lee, PhD

Christine Maheu, PhD

Sophie Blondin, MA

The objectives of our intervention are to

1. Ease the transition between cancer treatment and active life, and
2. Allow breast cancer survivors to take control of their lives.

The primary objective of this study is to:

1) Determine whether individual life coaching (i.e., individualized guidance that helps to put resources into action) can significantly improve quality of life and post-traumatic growth among women who have been recently treated with breast cancer.

It is hypothesized that:

1. Participants who receive both "group coaching sessions" and "individualized coaching sessions" will report greater post-traumatic growth and quality of life, and less fear of cancer recurrence when compared to the breast cancer survivors who received only the group coaching sessions or usual care.
2. Participants who receive only the group coaching sessions will report greater post-traumatic growth and quality of life, and lesser fear of cancer recurrence when compared to the participants who receive usual care.

Life After Breast Cancer - Impact of a Life Coach

Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference

The PTGI consists of 21 items, the response scale is a 6-point Likert scale asking respondents the degree to which changes occurred in their lives as a result of the crisis, where 0 represented "I did not experience this change" and 5 represented "I experienced this change to a very great degree". The PTGI is composed of 5 subscales, with 5 items measuring the construct New Possibilities, 7 items measuring the construct Relating to Others, 4 items measuring the construct Personal Strength, 3 items measuring the construct Appreciation of Life and 2 items measuring the construct Spiritual Change. The scores are summed to provide an overall measure of post-traumatic growth ranging from 0 - 105 where higher scores indicate more reported growth.

The CWS is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The six items are rated on a 4-point Likert scale ranging from 1 ("never") to 4 ("almost always"). Possible scores range from 6 to 24 with higher scores indicating more worry.

The PROPr is a 31-item instrument assessing eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity), and Cognitive Function Abilities (2 items). Raw scores generated for each domain are transformed into T scores; higher PROMIS T scores indicate greater endorsement of the construct being assessed.

Quebec Breast Cancer Foundation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Principal Investigator

Disease Attributes

Patient will receive the Mini-AFTERc intervention after completion of primary breast cancer treatment.

Patients will receive usual care after completion of primary breast cancer treatment.

Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.

Mini-AFTERc

Gerry M Humphris, PhD

Calum T McHale, PhD

People treated for breast cancer often live with an ongoing fear that the cancer will recur. This fear may develop and impact on their mental health and quality of life. The Mini-AFTERc study is a pilot trial of a brief cognitive behavioural communication intervention, designed to reduce fear of cancer recurrence (FCR) in breast cancer patients. This pilot trial aims to determine the acceptability and practicality of introducing the Mini-AFTERc intervention into everyday practice, and inform the development of a full randomised controlled trial.

The objectives of this pilot trial are as follows:

1. To develop a procedure for training breast cancer nurses (BCN) in the delivery of the Mini-AFTERc intervention and introduce the intervention into current NHS service provision for breast cancer patients.
2. To collect data to pilot and test recruitment (of breast cancer nurses and breast cancer patients), the fidelity of intervention elements, the acceptability to participants (primary and secondary outcomes) and detailed economic indicators for a full trial.
3. Apply a formal decision making framework (ADePT) to determine a profile of factors to reveal potential difficulties and appraise solutions prior to a full trial.

This study is a multicentre controlled pilot trial of the Mini-AFTERc intervention and will take place in 4 breast cancer centres in NHS Scotland health boards, including Fife, Highlands, Lothian and Tayside. Two centres will deliver the intervention (Fife and Lothian) and 2 centres will deliver usual care to patients, acting as control centres (Highlands and Tayside). The project will be delivered in 3 phases:

Phase 1 will include the development and delivery of the Mini-AFTERc intervention training package for breast cancer nurses.

Phase 2 will include patient recruitment and data collection. There will be 2 intervention centres and 2 control centres across NHS Scotland. Patients who have completed their primary breast cancer treatment, will be screened for moderate FCR (scoring ≥10 and \<15 on the Fear of Cancer Recurrence 4-item Scale; FCR4). Breast cancer nurses will deliver the intervention by telephone in intervention centres, which will be audio recorded. Patients will complete a satisfaction questionnaire after the intervention (CARE and MISS). Follow-up questionnaires measuring fear of cancer recurrence, anxiety and depression and quality of life outcomes (FCR4, HADS, EQ-5D) will be delivered via a smartphone app at 2 weeks, 1 month and 3 months following intervention or 3 weeks, 5 weeks and 13 weeks following screening for the control group. Semi-structured interviews with 20% of patients and all nurses will be conducted to assess experiences and acceptability of the intervention.

Phase 3 will conduct data analysis and trial evaluation. Screening and follow-up data will be quantitatively analysed, including structured equation modelling. Interviews will be subject to framework analysis based on normalisation process theory (NPT). The pilot trial will be systematically evaluated using a process of decision making after pilot and feasibility trials (ADePT).

The findings will help to understand if this brief intervention can be implemented in everyday practice and can reduce FCR. They will also inform the practicality of implementation of a larger-scale randomised trial.

Mini-AFTERc Intervention for Fear of Cancer Recurrence

A Pilot Trial of the Mini-AFTERc Intervention to Manage Fear of Cancer Recurrence in Breast Cancer Patients

Assessed using the Consultation and Relational Empathy (CARE) measure, validated for use in secondary care (Mercer et al. 2004). The CARE measure asks patient to rate their nurses' communication skills on 10 communication and empathy domains (e.g. 'How was your nurse at fully understanding your concerns?'). Patients rate nurses from 1 ('Poor') to 5 ('Excellent') for each of the 10 domains.

The FCR4 is a 4-item measure designed to assess patient anxiety, worry and strong feelings associated with the return of cancer (e.g. 'I am afraid that my cancer may recur'). The research group has validated the FCR4 as an accurate measure of cancer recurrence fears in breast cancer patients that is fit for routine use in clinical services (Humphris, Watson, Sharpe, \& Ozakinci, 2018). Each question in the FCR4 is rated by the patient on a scale of 1 ('Not at all') to 5 ('All the time'). A cumulative score of ≥10 (60 Percentile) across all 4 items is defined as 'moderate' fear of cancer recurrence and a cumulative score of ≥15 is defined as 'high' fear of cancer recurrence.

The HADS is a 14-item assessment tool used to screen for anxiety and depression the general medical population (Zigmond \& Snaith, 1983). The HADS is well established tool and has been employed in a multitude of medical settings, including oncology, to assess patients' mental health (Hartung et al., 2017; Vodermaier \& Millman, 2011). The HADS assesses two domains, depressionand anxiety. Patients report symptoms of depression and anxiety in the last week on a 4-point Likert scale, from 0 (e.g. "Not at all") to 3 (e.g. "Most of the time").

The EQ-5D is a standardised instrument of health-related quality of life, developed by the EuroQol Group (Herdman et al., 2011). The EQ-5D assesses 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D contains 6-items, 5 of these items assess each of the 5 dimensions and are rated on a 5-level (5L) scale. The final item is a measure of health state, which is rated on a scale of 0 ('worst imaginable health state') to 100 (Best imaginable health state').

Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of breast cancer nurses. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).

Assess number of patients recruited at each site, including those who decline to participate.

Assess number of patients who complete the trial.

Assess number of patients who do not complete the trial, withdraw or drop-out.

Semi-structured interviews with patients will explain and evaluate the underlying mechanisms of implementing the Mini-AFTERc intervention into routine cancer care from the perspective of patients. Normalisation Process Theory (NPT) will provide a theory-driven framework for addressing this outcome. NPT aims to provide coherence, as well as assessments of cognitive participation, collective action and reflexive monitoring (Murray et al. 2010).

University of Stirling

University of Surrey

Swansea University

Chief Scientist Office of the Scottish Government

University of St Andrews

Professor of Health Psychology

All Drugs and Chemicals

Tin Fluorides

Immunomodulating Agents

If the patient is randomized to this arm, they will be asked to stop their immunotherapy

Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.

cognitive behavioral therapy

Jennifer L Steel, Ph.D.

Jason Luke, MD

Jason Luke

The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.

The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.

All patients will receive treatment and be evaluated pre- and post-treatment

Fear of Recurrence and Stopping Immunotherapy

Distress Associated With Stopping Immunotherapy of Cancer Patients

University of Pittsburgh

Professor

Observation over a period of all treatment sessions for radiotherapy

Gerald M Humphris, PhD

This pilot study concentrates on studying the trajectory of breast cancer patient's fear of recurrence (FoR) over the course of radiation therapy. The aim is to collect repeated ratings of 100 breast cancer patient's FoR over the course of their treatment. It is hypothesized that cancer patient's FoR level will rise on nearing the termination of the in radiotherapy treatment, and radiotherapist-patient interaction modifies the development of patient's FoR.

The aim of this pilot study is to examine the collection of FoR levels in a longitudinal design with 100 breast cancer patients receiving radiotherapy for their disease. In this study, an intensive longitudinal design will be employed (Bolger \& Laurenceau, 2013). There will be two data collection types. First, will be self-reported questionnaires. Patients will complete questions including three sections: 1) demographic information (i.e. age, education, employment, marital/family status), 2) a 7-item FoR scale (ACCRE FCR) and 3) a 20-item Affect Schedule (PANAS) before first radiation treatment (T1). Throughout the period of treatment, a 3-item FoR questionnaire (ACCRE FCR 3 Items) will be designed as a daily diary to monitor patient's FoR level. Then, at the end of the radiotherapy treatment (T2), PANAS will be measured again. Finally, six-eight weeks after the end of the treatment (T3), all participants will be asked to complete the 7-items FCR questionnaire once again as well as a 5-item EuroQoL EQ-5D-3L scale by telephone.

The second data collection media is audiotape. The conversations between radiotherapist and patient in the weekly review appointment will be recorded and a behavioural coding system (VR-CoDES) will be used to analyse the interactions between patient and radiotherapist.

Data analysis will involve statistical analysis and qualitative methods. Statistical analyses will be conducted using Statistical Package for the Social Sciences (SPSS) Analytics software v.22, Analysis of MOment Structures (AMOS) v.22 and MPlus™ (SEM: Structural Equation Modelling). Initial analysis will plot individual and group average curves over the days that patients are treated. The analysis will develop a statistical model based upon SEM principles of growth curves. Each patient is expected to disclose increased fears of recurrence over the course of treatment. Latent curve modelling will be developed to test the relationship of FoR over the time course of the treatment.

As part of this pilot study the investigators wish to investigate the appropriateness of these models and to test the extent of growth of FoR to the outcome at 6-8 weeks follow up, using the FoR 7 item measure. Covariates will be introduced for control purposes and indicate initial level of negative affectivity (The Positive and Negative Affect Schedule - PANAS), age and initial level of disease severity. Alternative strategies of analysis are considered appropriate and may enable a parallel strategy. This would involve a simpler approach concentrating on the raw data. Linear modelling (multi-level) which will include estimation of linear slopes being used to predict FoR outcome.

Audio recordings of the consultation will be transcribed verbatim in order to investigate how the radiotherapist-patient communication affects the development of FoR.

Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment

Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment and Follow-up Into Survivorship of 100 Breast Cancer patients-a Pilot Study

The ACCRE FCR scale has been employed in a national study, it ranges from 4-20. A score of 10 is a significant level (60th percentile) considered appropriate for the patient to receive a brief intervention.

The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure of positive and negative affect. The PANAS has been shown to possess adequate psychometric properties in a large sample drawn from the general adult population, and the construct validity of the PANAS scales and the reliabilities of both scales were adequate, Cronbach's α were 0.89 for Positive Affectivity and 0.85 for Negative Affectivity (Crawford \& Henry, 2004).

The EQ-5D-3L is a standardised instrument for use as a measure of health outcome and was developed by the EuroQol Research foundation. It consists of five questions relating to five dimensions of health; mobility, self-care, usual activities, pain and discomfort and anxiety and depression. The EQ-5D has well-established validity and reliability and has been used in many studies of patients with a variety of chronic conditions in many different countries (Schrag et al., 2000; Walters \& Brazier, 2005).

NHS Lothian

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist.

Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.

Participants randomized to this arm will be allocated a pre-registered Inspire II / Charge IV model Fitbit. The kinesiologist of the study will meet with the participants for a baseline fitness assessment. The kinesiologist will examine the baseline physical activity levels, fitness level and sedentary behaviours of the participants, to design a personalized exercise prescription. Within one week after the baseline fitness assessment, the kinesiologist will contact the participants to discuss the exercise prescription. Every two weeks there-after, the kinesiologist will follow up with the participants via videoconferencing to discuss their progress and to modify or advance their exercise prescriptions as needed. Participants will be followed-up at 6 months and 12 months.

Lymfit exercise intervention

Participants will be contacted by the study kinesiologist for a baseline fitness assessment 3 months after they consent, participants will be given a Fitbit, a personalized exercise prescription and receive bi-weekly follow-ups for 12 weeks.

Waitlist control

Christine Maheu, Ph.D.

Christine Maheu

This randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

Lymphoma is the most common cancer diagnosed in young adults. While curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. Regular exercise has the potential to reduce the side effects associated with cancer treatments. Thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment.

However, these guidelines are not systematically recommended by doctors and are often not followed by patients. Fatigue and lack of motivation are the main barriers to exercise among cancer survivors. Our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. The investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. Our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors

Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors: A Randomized Controlled Trial

The investigators will determine the percentage of lymphoma patients who adhere to the recommended exercise guidelines for cancer patients at baseline and after the intervention, i.e. compare the minutes of Moderate to vigorous physical activity per week captured in the Fitbit among participants in the intervention arm and waitlist control arm at baseline and 3 months.

The Patient-Reported Outcomes Measurement Information System-29 is a 29-item instrument assessing multi-dimensional eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity). Raw scores generated for each domain are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed.

The Work Ability Index (WAI) questionnaire (7 items) will be used to collect productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor \[7-27\], moderate \[28-36\], good (37-43) and excellent (44-49).

Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).

Jewish General Hospital

McGill University

Associate Professor

Eye Diseases

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Eye Neoplasms

Uveal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Patients wiill be asked to fulfill questionnaires at inclusion and 6 months after. An interview will be offered to a sub-sample of patients (approximately 20 patients).

Questionnaires and interviews

Anne BREDART

Anita MULLER

The goal of this prospective observational study is to learn about patient quality of life and experience and medical information needs during uveal melanoma post-treatment surveillance. Participants have previously undergone treatment for non-metastatic uveal melanoma and have integrated a oncological and / or ophthalmic surveillance protocol based on their individual genomic and / or clinical risk of recurrence. The main objectives it aims to assess are:

* To evaluate the effect of satisfaction with communication with the oncologist/ophthalmologist during the oncology/ophthalmology surveillance visit 6 months after the start of surveillance (T1) on the overall level of health status/quality of life (QoL).
* To explore the impact on psychosocial resources and needs such as fear of recurrence, anxiety and depression 6 months after the start of surveillance (T1) and 12 months after the start of surveillance (T2).
* To document patients experience of care and communication during the first 12 months of surveillance.

Participants will fill in quality of life questionnaires at two timepoints. A sub-sample will be offered to participate in qualitative research interviews. Researchers will compare data from patients at low risk of recurrence with those at high risk of recurrence to see if there are significant differences with regards to quality of life, satisfaction with care and medical information needs.

Context and scientific background Uveal melanoma (UM) is the most common malignant ocular tumour in adults. It is a rare disease with an incidence of four to seven new cases per million per year in western countries (Mathis, 2018). The diagnosis of uveal melanoma is usually made when vision problems appear and the disease is still at a localized stage (in 95% of cases). Historically, the standard treatment for uveal melanoma was enucleation. Today, around 75% of patients can benefit from conservative treatment approaches such as brachytherapy or proton beam therapy without increasing the risk of metastasis or affecting survival. The visual prognosis of uveal melanoma depends on the localization of the tumour and efficacy of the treatment. Vital prognosis depends on the metastatic risk, which is related to the tumours' size and genomic characteristics (AJCC 7th Edition, 2015).

Up to 50% of patients develop metastases within a median time range of 2 to 3 years (Tuomaala \& Kivelä, 2004). Metastatic progression develops most frequently in the liver (in \>80% of cases). Once the disease spreads to the liver, median survival ranges from 3 to 12 months (Mariani, 2012) and response to treatment is rare. Estimating metastatic risk allows to provide personalized surveillance. For high risk patients, current international recommendations (NICE 2015) advise surveillance with liver CT or MRI (magnetic resonance imaging) every 6 months for over 10 years. If uveal melanoma metastases are diagnosed early, surgical liver resection can be considered in 25% of patients (Mariani, 2016). For the remaining 75%, systemic palliative care is recommended.

Various studies have addressed the effects of localized uveal melanoma and its treatment on quality of life (QoL). The QoL of patients with uveal melanoma appears to be significantly lower compared to matched general population (Erim, 2016; Miniati, 2018). Within the two years after treatment, overall QoL appears to be similar in patients treated by either enucleation or radiotherapy (Hope-Stone, 2016). Furthermore, no difference has been found between these treatments regarding specific aspects of QoL such as the ability to drive, ocular irritation, headaches, concerns regarding body image, and fear of recurrence (Hope-Stone, 2019). However, 6 months after treatment, functional difficulties are more important in enucleated patients, whereas difficulties in central and peripheral vision as well as in reading are higher in patients treated by radiotherapy (Hope-Stone, 2019). A large prospective study, conducted over a 20 year-period, concluded that overall quality of life was worse in enucleated patients than in patients treated with radiotherapy. However, this difference is not attributed to the treatment but to factors predisposing to treatment choices such as a more severe disease (e.g., larger tumour) (Damato, 2018).

During post-treatment surveillance, important aspects of QoL appear to be altered in patients treated for uveal melanoma. Depression and QoL levels seem to be worse around three months post-treatment (Amaro, 2010). Specific problems affecting QoL persist such such as body image troubles, especially in enucleated patients, as well as psychological adjustment, and social functioning difficulties, especially when vision problems persist.

As reported by items of the EORTC QLQ-C30 questionnaire, 39% of patients may have significant vision problems and 33% may report being 'worried about their future health' (Frenkel, 2018). The latter issue refers to fear of cancer recurrence (FCR) which is defined as the "fear, worry, or concern relating to the possibility that cancer will come back or progress" (Lebel, 2016). It is characterized by intense worry, intrusive thoughts and difficulty planning the future. Fear of recurrence (Suchocka-Capuano, 2011; Damato, 2018) has shown to be high and persists over time. These fears are related to uncertainty regarding future health. They result in anxiety and depressive symptoms, which significantly affect overall quality (Hope-Stone, 2015). Risk factors predisposing to distress include tumour stage and time since the beginning of surveillance. (Klingenstein, 2020) and persistent or emerging post-treatment symptoms and functional limitations (Brown, 2021). To our knowledge, only one study has examined unmet needs in patients with non-metastatic uveal melanoma, highlighting significant unmet medical information and psychological needs within 1 week after diagnosis and 3 months later (Williamson, 2018).

Prognostication tools based on clinical and genomic factors are available in routine practice (Cassoux, 2014). These tools may be used in consultation to inform cancer patients about the estimated risk of recurrence and associated life expectancy. Studies evaluating the psychosocial impact of communicating genomic test results and informing patients about their risk of cancer recurrence have been conducted primarily with breast cancer patients to guide the choice of adjuvant therapy. They suggest that a poor understanding of genomic tests results leads to increased anxiety (Pellegrini, 2012). Higher levels of anxiety are also related to lower satisfaction with having this testing done (Tzeng, 2010). Regarding the utilization of these tests in patients with uveal melanoma, studies from Anglo-Saxon countries report that many patients want to be informed of the genomic test result indicating their risk of metastatic recurrence (Beran, 2009; Damato, 2013; Brown, 2020). Risk estimations are provided in the form of numbers accompanied by graphs or pictograms to help interpret and understand the information, and thus enable informed decision-making concerning care and monitoring. However, a significant number of patients also experience regrets about being informed of their genomic test result and risk of recurrence, regardless of their personal risk status (Schuermeyer, 2016).

MRI appears to be the most sensitive screening method available for the early detection of metastases (Piperno-Neumann, 2015). Institut Curie has developed a clinical trial in which patient surveillance is tailored based on the risk of metastatic recurrence. In this trial, patients at high risk of recurrence receive liver MRI every 6 months. As for patients at high risk intense surveillance in terms of frequency and type of medical testing is recommended, patients may know that they have a higher risk of disease recurrence. However, there is no scientific data on this. Therefore, it is important to assess how patients with uveal melanoma at high risk of recurrence perceive the information provided by the oncologist (e.g. regarding risk of recurrence testing) and to evaluate its impact on quality of life, and more precisely, fear of recurrence. In general, cancer patients whose information needs are met have better QoL and lower levels of anxiety and depression (Husson, 2011). Nevertheless, up to now, we have little knowledge about the relation between information needs and QoL in UM patients (Lieb, 2020). This study shows that prognostic testing may help to alleviate distress and promote more realistic risk perception. Furthermore, even less information exists in French culture, where the communication of precise numeric estimations of recurrence risk may not be well accepted. Cultural factors affect patients' care needs, their expectations and expression of wishes, and influence clinicians' attitude in the relationship and communication with patients. Specifically, Anglo-Saxon cultures tend to value self-determination and autonomy, which impact the amount, precision and timing process of the medical information requested or provided in situations of medical uncertainty (Razavi, 2019).

Moreover, most studies on quality of life and psychosocial needs in patients affected with UM as cited above are conducted in countries with an Anglo-Saxon culture (Schuermeyer, 2016; Damato, 2018; Hope-Stone, 2019). Studies performed in other countries do not have a prospective design (Moschos, 2018; Frenkel, 2018) and use heterogeneous quality of life assessments which make comparisons and synthesis of results difficult (Miniati, 2018). To sum up, we lack robust, prospective data on needs and satisfaction with type and amount of information provided and their impact on QoL in French cancer patients with either a confirmed high risk or low risk of relapse. Advances in prognostication of cancer recurrence and identification of predictive biomarkers of response to treatment in oncology as well as the availability of genomic tests in clinical practice (Cassoux, 2014; Piperno-Neumann, 2019), increase the importance to evaluate how French patients perceive medical communication about the results of these tests and their impact on QoL and fear of metastatic relapse.

A patient-centered approach seems to enhance QoL (Brédart, 2013; Castro, 2016). Patient-centered care entails attention to the patient's communication needs, personalized information, emotional support, care coordination and continuity. This kind of approach promotes patient's ability to remember medical information, understanding of medical recommendations, and satisfaction with care. Furthermore, it can minimize uncertainty and distress. In the context of uveal melanoma, patients may expect information regarding their risk of metastatic recurrence, which enables them to anticipate potential medical and/or personal consequences (e.g., on medical follow-up, personal life choices). In this context, some patients may need major attention and emotional support from their physician. A referral to psychological counselling and further supportive care may also be helpful (Hope-Stone, 2018).

In uveal melanoma, the information of high metastatic recurrence risk is generally communicated by an oncologist to whom the patient is referred and who implement a first oncology surveillance visit (\~ 2 months post-treatment). This patient generally does not see his/her hospital ophthalmologist anymore. In contrast, UM patients at low risk of recurrence continue to be follow-up by this specialist in collaboration with an extra-hospital ophthalmologist. Patients' QoL and fear of recurrence may be affected by their satisfaction with the interactions with clinicians and cancer care services. For UM patients these aspects are thus relevant in terms of patient-reported outcomes. Studies with breast cancer patients have shown that sharing emotions with physicians can reduce fear of recurrence after radiation therapy. It reflects the effect of communication processes on this aspect of QoL (Humphris, 2019). To our knowledge, the association between the patients' satisfaction with information and their QoL and fear of recurrence has never been explored in the context of non-metastatic uveal melanoma at either high or low recurrence risk.

Methodology This is a single-centre, prospective observational study, which combines a quantitative and qualitative research approach. This mixed method design will enable to explore the relationships between patients' experience of communication with the oncologist, and quality of life, and fear of recurrence.

At six months (+/- one month) after the end of treatment (T1), patients will be invited to participate in the study. They will be invited to complete a set of questionnaires, including the EORTC QLQ-C30, EORTC QLQ-OPT30 quality of life questionnaires and the FCRI Fear of cancer recurrence inventory. Patients will be invited to complete some of these measures again at T2, i.e. 12 months (+/- one month) post-treatment. Clinical data will be collected at T1 by the researcher.

A complementary sequential qualitative study will be conducted involving a random sub-sample of the study population after completion of questionnaires. A purposive sampling will target an equivalent number of patients per UM treatment (enucleation vs radiotherapy only) and surveillance modality (MRI for high risk vs CT scan only for low risk).

An interview guide will be developed to explore: how oncologist- or ophthalmologist-patient interactions potentially relate to fear of recurrence and quality of life during the first 6-month of follow-up; how oncologist or ophthalmologist-patient interactions can minimize the effect of factors such as physical symptoms and functional limitations which are likely risk factors for persistent fear of recurrence (Brown, 2021); what about the more intensive follow-up of uveal melanoma at high risk of recurrence, the information given and their impact on fear of recurrence and quality of life? Data are collected using psychometrically validated questionnaires, items adapted from the literature and from the medical records for age, gender and clinical information.

The EORTC QLQ-C30 (30 items) (Aaronson, 1993) is used to assess functioning difficulties, symptoms and general aspects of quality of life.

The EORTC QLQ-OPT30 module (30 items) (Brandberg, 2004) will be used to measure aspects of quality of life specific to ocular cancers and their treatments (e.g., ocular irritation or difficulties with daily activities).

For both the QLQ-C30 and QLQ-OPT30, a score from one to 100 is calculated on each scale. A high score for a functional scale or the global health status/QoL denotes high/healthy level of functioning and high QoL, while high score on symptom scales denotes high level of symptomatology/problem.

The FCRI (42 items) (Simard, 2009) measures fear of cancer recurrence in seven factors: Triggers, Severity, Psychological Distress, Coping Strategies, Functioning impairments, Insight, and Reassurance. The total score ranges from 0 to 168. A higher score indicates a higher level of fear of recurrence. A cut-off score of 13 on the FCRI Severity Subscale was found to be associated with optimal sensitivity and specificity for detection of clinical levels of FCR.

Anxiety and depression are assessed by the HADS (14 items) (Zigmond \& Snaith, 1983; VF Razavi et al., 1990). This questionnaire includes 14 items whose answers are scored 0 to 3 Higher scores indicate higher levels of anxiety and/or depression.

The EORTC QLQ-INFO25 (25 items) (Arraras et al., 2010) is used to assess the perception of information about the disease and treatment. It is composed of 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. Response to each item are scored from 1 to 4. The sum of scores by dimension is transformed into a score from 0 to 100 scale. A high score on a given subscale indicates a higher amount of received information or of higher levels of satisfaction. Among single items, one addresses the wish to receive additional information and another the wish to receive less information, with response options yes versus no.

Multi-item subscales of the EORTC PATSAT-C33 (27 items) (Brédart, 2018) are used to assess technical skills, information exchange and interactions with physicians; and services and organisation of care in terms of coordination of care and interactions with all care professionals. In this project we will also use a single item assessing overall quality of care.

The multi-item scales or single items are scored in a similar way: (1) the scores of the individual items in a scale are first summed up and then, for multi-item scales, divided by the number of items in the scale; (2) these single item/scale scores are then transformed in order to obtain a score range from 0 to 100, with a higher score representing a higher level of satisfaction with care/perceived quality of care.

Data collected from clinicians: Perception of the surveillance consultation as well as satisfaction with the consultation are assessed by a 6-items questionnaire similar to the questionnaire addressed to patients.

Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study

EORTC QLQ-INFO25 item on overall satisfaction with information

Communication experience will be assessed by analogue patient and clinician questions (perception of information and communication, knowledge related to examinations and prognostic testing, benefits and risks of providing medical information, particularly concerning the risk of metastatic recurrence). Furthermore, clinicians years of experience will be assessed.

Subscale coordination of the EORTC PATSAT-C33 module will be used to compare level of satisfaction in patient at high versus low risk of recurrence.

The subscale "doctors" of the EORTC PATSAT-C33 will assess satisfaction with care and satisfaction with communication will be assessed by the EORTC QLQ-INFO25, at T1 each. Their effect on Fear of cancer recurrence will be measured by the FCRI at T1 and T2.

Coping strategies will be assessed by the subscale of FCRI.

Different dimensions of quality of life will be assessed by the EORTC QLQ-C30. Anxiety and depression will be measured with HADS, furthermore additional items will assess the wish for psychological counselling. EORTC QLQ-OPT30 will assess symptoms and how the modulate quality of life and especially psychosocial variables.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Psychological and Physical Distress and Care Needs in Operable Lung Cancer Patients Receiving Surgery	NCT01362842	Anxiety Postope... Patient Non-Com... Psychological D...		20 Years -	National Taiwan University Hospital
Life After Breast Cancer - Impact of a Life Coach	NCT05020561	Survivorship Breast Cancer	Group life-coac... Individual life...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Life After Breast Cancer - Impact of a Life Coach	NCT05020561	Survivorship Breast Cancer	Group life-coac... Individual life...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Mini-AFTERc Intervention for Fear of Cancer Recurrence	NCT03763825	Breast Cancer Fear of Cancer	Mini-AFTERc	18 Years -	University of St Andrews
Fear of Recurrence and Stopping Immunotherapy	NCT04761328	Cognitive Behav...	cognitive behav...	21 Years -	University of Pittsburgh
Fear of Cancer Recurrence (FoR) Trajectory During Radiation Treatment	NCT02599506	Breast Cancer		18 Years -	University of St Andrews
Lymfit to Improve the Fitness and Quality of Life in Lymphoma Survivors	NCT05257785	Lymphoma Cancer Survivor...	Lymfit exercise... Waitlist contro...	18 Years - 39 Years	McGill University
Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study	NCT06073548	Uveal Melanoma	Questionnaires ...	18 Years -	Institut Curie
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Mini-AFTERc Intervention for Fear of Cancer Recurrence	NCT03763825	Breast Cancer Fear of Cancer	Mini-AFTERc	18 Years -	University of St Andrews

Spots Global Cancer Trial Database for fear of recurrence