Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Vulvar Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

During treatment and routine follow-up consultations, patients randomized to standardized care will be provided with usual care and a predefined set of additional written information leaflets about supportive care options in the early treatment phase designed for the study.

During treatment and routine follow-up consultations, patients randomized to standardized care + WOMAN-PRO II program will be provided with usual care and nurse-led follow-up consultations with the WOMAN-PRO II program complementary to physician appointments.

During treatment and routine follow-up consultations, patients randomized to standard care will be provided with usual care and a predefined set of additional written information leaflets about supportive care options in the early treatment phase designed for the study.Usual care includes treatment during hospitalization by the gynecologist and the nurses according to the existing guidelines. At each follow-up visit, the gynecologist will conduct a physical examination. The follow-ups include also treatment of adverse effects of the therapy and rehabilitation.

standardized care (Intervention I)

This intervention is in addition to standard care. Nurse-led follow-up consultations with the WOMAN-PRO II program complementary to physician appointments have the goal to support women's self-management abilities in order to deal with occurring symptoms and related distress. Content of the WOMAN-PRO II program designed for this study is summarized in a handbook for professionals including patient clinical pathways and nurse interventions, supplemented by a patient booklet (paper based and electronic version) with tailored information according to patients' needs. The program includes five consultations with an approximate total duration of two hours.

Standardized care + WOMAN-PRO II program (Intervention II)

Beate Senn, PhD, RN

In vulvar neoplasia, even minor surgical interventions cause multiple symptoms, symptom distress and complications, which have an impact on a woman's quality of life and contribute to high health care costs. For the majority of the patients, symptom and distress can be reduced if adequate treatment is provided. This study aims to test possible differences between the impact of standardized care and the WOMAN-PRO II program on symptom prevalence in women with vulvar neoplasia after surgical treatment.

In a sequential explanatory mixed-methods project, a randomized phase II study will be followed by a qualitative sub-study. Ninety patients with vulvar neoplasia treated surgically will participate in the randomized trial in four Swiss hospitals and one Austrian hospital. After stratification by precancer/cancer, women will be randomly assigned (1:2 ratio) to standardized care and the WOMAN-PRO II program. The standardized care group will receive a set of information leaflets about supportive care options in the clinic. The WOMAN-PRO II program group will obtain counseling sessions by specially trained gynecology-oncology nurse specialists at the moment of diagnosis, 7 days post-surgery, in week two after discharge, week twelve and week 24 after surgery. The primary outcome of this study is symptom prevalence. Secondary outcomes will be collected for explorative reasons and include symptom distress, uncertainty, quality of life, social support, resilience, quality of care, sociodemographic and medical characteristics, post-surgical complications, functional status, cost evaluation and process outcomes. Quantitative data will be collected at the counseling points of time and analyzed by using mixed linear regression analysis. Twenty interviews will be conducted with women of the WOMAN-PRO II program group. A focus-group interview will be conducted with twelve gynecology-oncology nurse specialists in order to better understand to which degree the interventions meet individual needs as well as to identify remaining barriers and enablers for the implementation of symptom self-management. Qualitative data will be analyzed by using thematic analysis and a critical hermeneutic reflection.

This study will evaluate the impact of the WOMAN-PRO II program on symptom prevalence, patient-reported outcomes and clinical parameters, and inform the design of a possible phase III study on the clinical efficacy of the program.

The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence

The Impact of the Self-management Intervention "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence: A Mixed-Methods Project

The primary endpoint of the quantitative study is symptom prevalence, defined as a number of occurring symptoms on predefined time points from diagnosis (t0) across repeated measurements to follow-up assessment at six months after surgery (t4) Symptom prevalence after surgical treatment of vulvar neoplasia will be measured with the German WOMAN-PRO symptom diary. This self-report patient-reported outcome measure covers 31 symptoms occurring after surgery: 15 wound-related symptoms, 5 difficulties in daily life and 11 items that inquire about psychosocial feelings, thoughts or activities. For wound-related symptoms and difficulties in daily life, women are asked to rate how frequently they experienced the symptom/difficulty during the last seven days (never, for 1-2 days, 3-4 days, or 5-7 days).

Symptom severity after surgical treatment of vulvar neoplasia will also be measured with the WOMAN-PRO symptom diary. This self-report patient-reported outcome measure covers 31 symptoms occurring after surgery: 15 wound-related symptoms, 5 difficulties in daily life and 11 items that inquire about psychosocial feelings, thoughts or activities. For the psychosocial symptoms/issues, women are asked to assess the severity of symptoms (not at all, a little bit, quite a bit, very much).

The Mishel Uncertainty in Illness Scale (MUIS) is a 30-item scale detecting uncertainty in symptomatology, diagnosis, treatment, relationship with caregivers, and planning for the future.

The validated German and English Short Form (SF-36) will be administered. It utilizes scale profile, 36 questions and a one-week recall period. It contains eight subscale scores: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Items are rated on a 3-6-point Likert scale.

The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale designed to assess three aspects of perceived social support. The tree aspects comprise support from friends, family, and significant others.

Resilience refers to positive adaptation following stress or trauma. The original Connor-Davidson Resilience Scale brief version (CD-RISC 10) is a 10-item scale assessing resilience during the last month, with higher scores indicating higher resilience capacity.

The Patient Assessment of Chronic Illness Care (PACIC) instrument evaluates the quality and patient-centeredness of chronic illness care based on the Chronic Care Model (CCM)

Socio-demographic outcomes for patients will be collected with an 11-items form concerning age, marital status, number of children, education, employment status, living situation, post surgical wound management at home, and health insurance. The instrument was developed for patients following vulvar surgical treatment.

Clinical outcomes for patients will be collected with a 16-items form concerning diagnosis, cancer stage, initial treatment, and wound treatment. The instrument was developed for patients following vulvar surgical treatment.

The functional status, referring to the capacity to perform a variety of activities that are normal for most people, will be measured with the Eastern Cooperative Oncology Group Performance Status (ECOG-PS). ECOG-PS is a one item five-point scale using verbal descriptors, ranging from 0 "fully active" to 5 "dead". It was developed in 1960 for cancer patients and has been widely used by physicians and researchers to assess how a patient's disease is progressing and how it affects the daily living abilities.

The Assessment of Chronic Illness Care (ACIC) questionnaire was developed to assess if provided care is in alignment with the Chronic Care Model (CCM). The CCM comprises six areas: the organization of the health care system, the community linkage, self-management, decision support, delivery system design, and the clinical information system. The ACIC addresses how well a practice team or organization integrates the Chronic Care Model elements. Responses can be related to four descriptive levels from A "fully implemented" to D "little or none" implementation of the intervention.

The collection of three process outcomes during the implementation of a complex intervention program will allow to draw conclusions about potential barriers and facilitators of the interaction between patient and gynecology-oncology nurse specialist during the counseling intervention. (1) Counseling competencies and details of the complex interaction between patients and the gynecology-oncology nurse specialist will be assessed during the study period by audio-recording a random sample of 15-20 counseling sessions.(2) The gynecology-oncology nurse will document her experiences after each counseling session by keeping a diary to reveal her personal situation during the counseling process. (3) The WOMAN-PRO II program teacher will contact the gynecology-oncology nurse specialists every eight weeks and document the content of the discussions by keeping a diary after each contact.

Economic evaluation methods will be performed according to the recommendations of the NICE Reference Case. The economic evaluation will consist of a within-trial analysis and will compare direct costs and six-month outcomes of patients randomized to intervention II versus intervention I. Direct hospital costs will be the primary perspective. The study will record length of hospital stay, primary surgery costs, readmission, costs concerning intervention I, costs concerning intervention II, follow-up costs, patients non-productive time, and mortality. Comparison will be made between baseline and follow-up to estimate incremental cost-effectiveness ratio (ICER) comparing intervention II group with intervention I group in terms of the primary outcome measure (symptom prevalence) and costs.

Insel Gruppe AG, University Hospital Bern

University Hospital, Basel, Switzerland

Cantonal Hospital of St. Gallen

Medical University of Vienna

Cantonal Hospital of Lucerne, Switzerland

St.Gallen University of Applied Sciences

Symptoms and General Pathology

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Pharmaceutical Solutions

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Pharmacists conducted a standardized education session to teach the participants how to operate the mobile phone, use mini program, assess pain. The participants in the trial group were asked to complete initial and final pain assessment questionnaires and Medication compliance on the mobile phones provided to them. Participants were encouraged to use mini program as much as possible to record their pain status.

The control group received conventional pharmaceutical care. Initial and final pain and Medication compliance data were collected. Before the patient was discharged from the hospital, the clinical pharmacist conducted detailed medication education (including medication methods, prevention and treatment of adverse reactions, and precautions) and asked the patient to attempt to maintain a paper version of the pain diary.

To design, construct, and test the mini program in patients managing cancer pain

mini program

Regular education includes medication guidance from doctors, nurses and pharmacists.

conventional pharmaceutical care

QiuLing Zhao

With the existing medical system and insufficient medical resources in China, we developed a mini program. a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country . our study want to develop and test the mini program for pain management among Chinese cancer patients in or discharged from hospital treatment.

Healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. Integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management.

To design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.

Effects of Mobile Medicine on Cancer Patients

An Overall Solution for Full-course Oral Anti-tumor Drug Services Based on Mobile Medicine

Comparison of pain score of cancer pain patients with or without mini program. Pain score will be assessed by using numeric rating scale (NRS). An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."

The investigators will measure the change in medication adherence via Morisky Scale. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.

Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number of subjects who experienced an adverse event in this study is presented.

Comparison of quality of life of cancer pain patients with or without mini program. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D).

Fujian Cancer Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Behaviors and Mental Disorders

Kidney Diseases

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Heart Failure

Death

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Lung Diseases, Obstructive

Chronic Graft Versus Host Disease

Quality of Life

Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.

The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.

Outlook Attention Control

Outlook Intervention

Karen Steinhauser, PhD

James A Tulsky, MD

This study will demonstrate whether an end-of-life preparation and completion intervention reduces anxiety, depression, pain and other symptoms and improves functional status, spiritual well-being, and quality of life. If effective, the intervention offers a brief, inexpensive, and transportable non-physician treatment method for improving the experience of individuals in the latter stages of life-limiting illness.

Efforts to improve end-of-care often focus on pain and symptom control, but few, if any, effective interventions exist addressing preparation and completion. We designed an end-of-life preparation and completion intervention, based on the human development literature identifying life completion as a developmental task and the robust evidence in health communication and clinical psychology that addresses the value of expressing emotions and stress on health outcomes. Our specific aims are 1) evaluate the impact of an intervention that promotes discussions of end-of-life preparation and completion on health outcomes in dying persons, including pain and symptoms, physical function, emotional function (anxiety and depression), spiritual well-being, and quality of life at the end of life and 2) evaluate the content of the such discussions, examining task variation associated with gender, ethnicity, socio-economic status, quality of communication with family, spirituality, and stage of illness to improve understanding of the need for tailored intervention content based on demographics or location in the trajectory of illness. We propose a randomized control trial to evaluate the intervention. 140 patients with advanced cancer, CHF, ESRD, or COPD will be randomly assigned into one of two intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") will meet with a facilitator three times for a period of forty-five minutes each. In the first session, subjects will be asked to discuss issues related to life review. A week later, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone. In the final session, a week hence, subjects will focus on heritage and legacy. The subjects in the second group ("attention control") will meet with a facilitator three times for a period of forty-five minutes each and be asked to listen to a non-guided relaxation CD. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

Outlook: An Intervention to Improve Quality of Life in Serious Illness

National Institute of Nursing Research (NINR)

Duke University

Digestive System Diseases

Prostatic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All participants will participate in an interview with a researcher

The interview will last approximately 45 minutes, will be audio-recorded, transcribed, and analysed

Interview

Rosalind Adam

This is a qualitative interview study that aims to understand treatment burden in individuals who have experienced prostate or colorectal cancer treatment within the past five years. We intend to use patient and caregiver experiences to co-design interventions to optimise cancer aftercare.

Treatment burden is the workload of healthcare for patients and the consequences of this workload on patient function. Treatment burden has been associated with negative outcomes in stroke, heart failure, diabetes, and renal failure. Cancer is increasingly becoming a chronic condition, and involves a variety of self-management tasks for patients and their caregivers. In this study investigators will investigate treatment burden in people after prostate and colorectal cancer. Investigators will seek to understand patient and caregiver perceptions about cancer aftercare, and ways that services could be redesigned and improved to reduce treatment burden, and improve patient outcomes.

We will undertake a qualitative interview study, recruiting patients from general practices and oncology outpatient clinics who have completed potentially curative treatment for prostate or colorectal cancer, or who are on active surveillance or hormonal therapies for localised or locally advanced prostate cancer. We will purposively sample, to ensure that participants with comorbidities, those from lower socioeconomic groups, and rural dwellers are adequately represented. We will conduct interviews according to a schedule, informed by conceptual models of burden of treatment, Schwarzer's Health Action Process Approach, and Normalisation Process Theory.

Interviews will be filmed and/or audio-recorded and transcribed. Framework and thematic analysis will be used to analyse and synthesise the data. Participants will be given the chance to comment on outputs and findings (triangulation).

Investigators plan to use the results of this study, and excerpts from video interviews during co-design events, and to create new interventions to optimise aftercare for patients with prostate and colorectal cancer.

The number of individuals surviving for more than five years following a cancer diagnosis is steadily rising. Cancer is often a long-term condition. Individuals living beyond a cancer diagnosis are required to participate in a range of self-management activities, including (and not limited to) managing symptoms and comorbidities, self-monitoring for recurrence, adjusting to life beyond cancer/managing psychological sequelae, taking medications, attending follow-up appointments, and addressing unhealthy behaviours.

Treatment burden is the workload of healthcare for patients, and the effect that this work has on patient functioning and well-being. In the 1960s, Thomas Creer recognised that patient participation in their own healthcare was important in achieving disease control in paediatric asthma. Since then, "self-management" has been extensively researched and conceptualised. In the 1980s, Corbin and Strauss characterised three strands of "work" for people with chronic conditions: medical management, for example adhering to medication regimens and attending appointments; behavioural management, such as adopting healthier lifestyle practices; and the emotional management of adapting to a long-term condition.

Increasing patient participation in self-management has mostly been viewed as a positive strategy through which to improve health outcomes, reduce medical paternalism, and delegate some tasks away from over-burdened health and social care systems. Treatment burden is a relatively recent concept which highlights the potentially deleterious effects of increasing patient workload. Treatment burden is becoming increasingly relevant as more people survive into old age, often with combinations of comorbidities (including cancer) for which there are multiple available therapeutic agents and complex self-management regimens.

In diabetes, renal failure, heart failure, and stroke, there is increasing evidence that increased treatment burden is associated with reduced quality of life, non-adherence to therapeutic regimes, and wasted resources. Treatment burden is modified by patient capacity: those with lower self-efficacy, low levels of social support, financial difficulties, and competing personal workload can experience increased treatment burden. In cancer, certain large and distinct demographic groups, particularly rural dwellers and the socially deprived, have poorer survival after a cancer diagnosis. The mechanisms of these inequities have not been adequately explained.

It is feasible that treatment burden could modify interactions with health services, engagement with survivorship activities, and ultimately, cancer outcomes.

Treatment burden is a relatively recent concept which is under-explored in in cancer survivors.

The objectives of this study are:

1. To investigate patient perceptions of treatment burden after prostate and colorectal cancer.
2. To determine sources of treatment burden in prostate and colorectal cancer survivors, their interactions, and the perceived consequences of treatment burden.
3. To utilise key concepts from the interviews to build a video narrative, featuring video excerpts from participants to ensure that their voices reach a wider audience, including professionals. We will use these narratives to improve cancer services through co-design.

Qualitative interview will be conducted with approximately 40 patients, with or without linked caregivers. They will be transcribed verbatim, and analysed using Framework and thematic analysis.

The Improving Cancer Aftercare Study.

The Improving Cancer Aftercare Study. Using Patient and Caregiver Experiences to Assess Treatment Burden and Inform Health Service Design for People After Prostate and Colorectal Cancer. A Qualitative Semi-structured Interview Study.

Patient and caregiver perceptions of treatment burden assessed through semi-structured interviews and analysed by Framework and thematic analysis.

NHS Grampian

University of Aberdeen

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients assigned to the intervention arm fill in the eChemoCoach questionnaires. They will be asked to report their side effects at baseline (2 - 4 days before their first chemotherapy cycle) and weekly thereafter. Moreover, they can report their symptoms at any time in case of potential toxicity, with a maximum of once a day. Non-responders receive reminders. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation. Usability of the eChemoCoach will be assessed through an online survey for patients and healthcare professionals using the System Usability Scale

Patients in the control group receive standard of care. Both intervention and control groups receive standard monitoring and coaching, including pre-scheduled checks for side effects before chemotherapy. Patients in both groups are asked to complete questionnaires measuring the impact on HRQoL, anxiety, distress, and patient empowerment at baseline, 10 weeks, and 20 weeks post-chemotherapy initiation.

the eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition.

eChemoCoach

Manon Hanrath-Komen, PhD

Rubin Verduin, drs

Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.

Problem description: The aim of (neo)adjuvant chemotherapy is to increase survival. Therefore, treatment adherence is important. However, patients may experience treatment-related side-effects. In current practice, clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled. Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity, increase treatment adherence and reduce the decline in quality of life. Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity. Therefore, patients should receive a direct advice when experiencing side-effects. However, without interference of a health care professional, this is not possible in standard care.

Solution / research direction: There is increasing evidence that incorporating patient reported outcomes (PROs) in clinical care enhances symptom monitoring in cancer patients. Therefore, it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which: 1) delivers a real-time personalized advice to the patient, based on CTCAE grading, after the questionnaire is completed and 2) is accessible for patients using an electronic health portal (EHP) of the electronic health record (EHR) to integrate the PRO data into the EHR.

Aim / hypothesis: To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects, on the occurrence of CTCAE \>= grade 3 toxicity.

Plan of investigation: To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire. Thereafter, a multicenter clinical randomized trial will start where patients with breast cancer qualifying for (neo)adjuvant chemo(immune)therapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring, or to standard of care monitoring solely. Primary objective is the overall rate of CTC grade \>=3 non hematological toxicity between both arms. Secondary objectives include relative dose intensity, health-related quality of life, experienced distress, the number of unplanned health care usage and costs.

Expected outcome: The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade \>=3 non-hematological toxicities.

A clinical randomized controlled trial will be performed in 746 breast cancer patients treated with (neo-)adjuvant chemotherapy. Patients will be randomized to the intervention group, using the eChemoCoach in addition to standard of care monitoring to manage side effects or are randomized to solely standard of care monitoring.

This is a open label study since blinding is not possible as healthcare professionals will receive the CTC gradation based on the reported side effects in the intervention group and are obligated to act on these reports.

Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial

The occurrence of any non-hematological side effects grade ≥3 during neo-adjuvant or adjuvant treatment

Time to occurrence of both grade 2 and grade ≥3 toxicity will be analyzed with a Kaplan-Meier curves.

Occurrence of grade 2 side effects during (neo)adjuvant will be presented as numbers with percentages for patients in both study groups.

For analyzing the RDI, the RDI will be calculated for each chemotherapeutic agent and presented as mean with standard deviations (SD) (for a description of calculation of the RDI see the objective section paragraph 2.0). The RDI will be calculated per cycle. The RDI will be compared between the intervention and the control group.

Health-related quality of life measured by the Quality of Life Questionnaire (QLQ-C30s). Scale is ranging from 1 to 4. 1 = not at all, 4 = very much. Higher scores mean a worse QOL.

Patient experienced anxiety measured using the Hospital Anxiety and Depression Scale. Scale is ranging from 0 to 3. 0 = often, 3 = never. Higher scores means a less worse Hads score.

Patient empowerment using Patient Activation Measure (PAM13) questionnaire. Ranging from 0 to 3. 0 = I do not agree, 3= I totally agree. A lower score is worse.

Patient experienced stress using a distress thermometer. Ranging from 0 to 10 per problem. 0 = no problem, 10 = worst. A higher score means more stress.

The amount of unplanned hospital care will be presented as median (IQR) and will be analyzed by comparing the number of admissions, unplanned visits, days of hospital admissions between the intervention and control group using Poisson regression analysis.

Cognitive interviews will be analyzed with thematic content analysis. Agreement between professional triage estimations and eChemoCoach will be quantified using Cohen's Kappa coefficient. A semi qualitative assessment will be conducted, comparing the patient-reported adverse effects using eChemoCoach with medical professionals' CTCAE severity assessments. Interviews will be analyzed with thematic content analysis.

The System Usability Scale will be used for global assessment of the eChemoCoach. usability. Usability will also be assessed by healthcare professionals from participating. sites. The SUS is a 10 item questionnaire with 5 response options. Ranging from strongly disagree to strongly agree. The average SUS score from all 500 studies is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average.

To assess the concordance among eChemoCoach-reported grades, PRO-CTCAE, and CTCAEs graded by healthcare professionals (HCPs), we employ the eChemoCoach platform for patient experienced symptom data collection. Each questionnaire administered includes the eChemoCoach and the PRO-CTCAE questionnaire, facilitating immediate and direct comparison of both outcomes. HCPs will document symptom grading in patient files using standardized CTCAE forms. HCPs will grade the severity on pre-planned checks (standard of care) and when necessary in case of severe side effects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence	NCT01986725	Vulvar Cancer Vulvar Intraepi...	standardized ca... Standardized ca...	18 Years -	St.Gallen University of Applied Sciences
Effects of Mobile Medicine on Cancer Patients	NCT05049811	Cancer Pain	mini program conventional ph...	-	Fujian Cancer Hospital
Effects of Mobile Medicine on Cancer Patients	NCT05049811	Cancer Pain	mini program conventional ph...	-	Fujian Cancer Hospital
Outlook: An Intervention to Improve Quality of Life in Serious Illness	NCT00939146	Neoplasms Pulmonary Disea... Heart Failure Renal Disease	Outlook Attenti... Outlook Interve...	18 Years -	Duke University
The Improving Cancer Aftercare Study.	NCT04163068	Colorectal Canc... Prostate Cancer	Interview	18 Years -	University of Aberdeen
Outlook: An Intervention to Improve Quality of Life in Serious Illness	NCT00939146	Neoplasms Pulmonary Disea... Heart Failure Renal Disease	Outlook Attenti... Outlook Interve...	18 Years -	Duke University
Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects	NCT06424054	Breast Cancer eHealth Symptom Monitor... Self Management	eChemoCoach	18 Years -	Noordwest Ziekenhuisgroep
Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects	NCT06424054	Breast Cancer eHealth Symptom Monitor... Self Management	eChemoCoach	18 Years -	Noordwest Ziekenhuisgroep
The Impact of the "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence	NCT01986725	Vulvar Cancer Vulvar Intraepi...	standardized ca... Standardized ca...	18 Years -	St.Gallen University of Applied Sciences

Spots Global Cancer Trial Database for self management