Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Quality of Life

Patients with high risk cutaneous squamous cell carcinoma of the head-neck area receiving regular, multidisciplinary care.

Patients receiving regular care. In addition, validated questionnaires are administered at two measurement points:

1. after the multidisciplinary consultation, a baseline questionnaire\*, the decision conflict scale and the EQ-5D-5L questionnaire are administered by phone.
2. 1 month after completion of the treatment program (care pathway) the EQ-5D-5L, the BaSQoL and the EORTC IN-PATSAT32 questionnaires will be administered by phone.

Completing the questionnaires takes about 30 minutes each time.

\*Baseline questionnaire: gender, age, marital status, education level, World Health Organization (WHO) performance status, presence of informal care, stage and treatment of cSCC, history of skin cancer, presence of current other skin cancer, and average travel time to hospital.

Regular care with additionally administration of questionnaires

Emmy Cruts, MD

S.F.K. Lubeek, MD, PhD

K Mosterd, MD, PhD

Patient reported outcomes in patients with high-risk cutaneous squamous cell carcinoma in the head-neck region are an important part of the complex care for these patients. Health-related quality of life, decision conflicts in the choice of treatment and satisfaction with care have not yet been sufficiently studied in this patient group.

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer worldwide after basal cell carcinoma. It involves approximately 20% of all cutaneous malignancies and its incidence is still increasing. In 2020, nearly 15,000 cSCCs were reported in the Netherlands, of which approximately 50% concerned patients aged 75 years or older. UV radiation is the main risk factor for development of a cSCC, therefore the majority of cSCCs are localized to the sun-exposed skin in the head-neck region. cSCCs have a metastatic rate of 2.6-5% and recurrence rate of 1.9-3.7%, with rates increasing in high-risk cSCCs. The increasing incidence, advanced age, the (often) high-risk localization in the head-neck area (given functional and cosmetic importance) and the possible high risk of metastasis result in complex care, especially in stage T2 to T4 cSCCs, also known as high-risk cSCCs.

Patient-reported outcomes and health related quality of life (HRQoL) are important outcomes in the care for high-risk cSCCs in the head-neck region (HNcSCCs). Previous research is limited regarding the impact of cSCCs on QoL in patients with high-risk HNcSCCs , as is research on decision conflicts in the choice of treatment. The PROFILES registry (Arts, 2019) investigated QoL and satisfaction with care in 215 patients with keratinocyte carcinomas in the head-neck region. However, the majority of the patients had basal cell carcinoma (81%); only 23 patients had cSCC. Besides, no distinction was made in high or low risk cSCC. Finally, quality of life and patient satisfaction questionnaires were not administered until at least one year after diagnosis.

Other studies of QoL in cSCC patients do not distinguish stage and/or location of the tumor, involve small study populations, or only use oncological questionnaires rather than disease-specific questionnaires.

In conclusion, there is little scientific research on health related quality of life, decision conflicts in the choice of treatment and satisfaction with care in specific patients with high-risk HNcSCCs.

Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region

Decisional Conflicts, Health-related Quality of Life and Satisfaction With Care in High-risk Cutaneous Squamous Cell Carcinoma in the Head-neck Region: Validated Questionnaires

Decisional conflicts expressed as mean total and domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and then multiplying by 25. The total score ranges from 0 to 100. A higher score correlates with a higher decisional conflict.

The 5 domain subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the (3 or 4) items, dividing by the number of items (3 or 4) and then multiplying by 25. The subscores range from 0 to 100 where a higher score correlates with a higher decisional conflict.

Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

Differences in decisional conflict outcome measures (primary outcome 1) between Maastricht University Medical Center+ and Radboud University Medical Center, expressed as mean total/domain scores on the Decisional Conflict Scale (DCS) questionnaire.

The DCS questionnaire consist of 16 items related to decision conflicts. Items are given a score value of 0 (strongly agree), 1 (agree), 2 (neither agree or disagree), 3 (disagree) and 4 (strongly disagree). The total score can be calculated by summarize all scores, dividing by 16 and multiplying by 25 (total score range 0-100). A higher score correlates with a higher decisional conflict. The subscores are: uncertainty (3 items), informed (3 items), values clarity (3 items), support (3 items) and effective decision (4 items). The subscores can be calculated by summarize the items, dividing by the number of items and multiplying by 25. The subscores range from 0-100; a higher score correlates with a higher decisional conflict.

Differences in health-related quality of life outcome measures (primary outcome 2) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 3) between Maastricht University Medical Center+ and Radboud University Medical Center. Health-related quality of life (HRQoL) expressed as mean total/domain scores on the EuroQol five-dimensional (5D) five-level (5L) (EQ-5D-5L) questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Differences in health-related quality of life outcome measures (primary outcome 4) between Maastricht University Medical Center+ and Radboud University Medical Center. HRQoL expressed as mean total/domain scores on the Basal and Squamous Cell Carcinoma QoL (BaSQoL) questionnaire.

The BaSQoL consist of 5 scales: behaviour, diagnosis/treatment, worries, appearance and other people. Items are scored: 0 (not at all), 1 (a little), 2 (quite a bit), 3 (very much). An average score per scale will be calculated (the sum of all scores within one scale, divided by the number of items) resulting in a scale score of 0 to 3. A higher score indicates a higher influence of skin cancer on daily life.

Differences in satisfaction with care outcome measures (primary outcome 5) between Maastricht University Medical Center+ and Radboud University Medical Center. Satisfaction with care expressed as mean total and domain scores on the EORTC IN-PATSAT32 (patient satisfaction) questionnaire.

The EORTC IN-PATSAT32 is composed of 11 multi-item scales (including doctors' and nurses' interpersonal skills, technical skills, information provision and availability, and other hospital personnel kindness/helpfulness and information giving, waiting time and access) and 3 single item scales (including exchange of information, comfort/cleanliness and general satisfaction). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high level of satisfaction with care.

The difference in HRQoL before and after treatment, expressed by mean total and domain scores on the EQ-5D-5L questionnaire.

The EQ-5D-5L consist of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 response levels (no, slight, moderate, severe or extreme problems) resp. coded from 1 to 5. The EuroQol-visual analogue scale records the overall health on a vertical visual analogue scale (0 to 100). Example: a response of 77 is coded 77. A higher score indicates a better health status).

Maastricht University Medical Center

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Tissue Adhesions

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Patients allocated in face-to-face appointment after urooncologic surgical procedures

Patients allocated in telemedicine appointment after urooncologic surgical procedures

remote post-operative appointment for small or medium urooncology procedures

Type of post-operative appointment

Romulo Nunes, MD

The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form.

All patients with urological neoplasms who have undergone low and medium complexity surgical procedures (e.g. prostate TUR, Bladder TURP, double-J passage, partial or total videolaparoscopic and open nephrectomies) at ICESP will be invited to participate. It will be excluded all patients undergoing emergency operations, outpatient procedures, major procedures, patients with probes or drains or no support for home telemedicine.A telemedicine platform for video conferencing will be used by the healthcare team at our institution. The information from the patient will be protected by security passwords following ethical and legal provisions.

The patient will be invited to participate in the study at the preoperative evaluation. If it agrees to participate, it will sign the agreement informed consent, and will be randomized in the Redcap® software to one of the study arms (post-operative consultations in person or telemedicine). Patient follow-up in the study will be carried out with the first post-surgery visit between 10 - 20 days after discharge, according to the type of consultation for which the patient was randomized pre-surgery. The main outcome assessed will be the degree of patient satisfaction assessed by using a Likert scale. For patients randomized to the telemedicine arm, the global perception of satisfaction in all aspects of the teleconsultation will be quantified through a Patient Satisfaction Assessment questionnaire served via telemedicine. It will also be evaluated the perception of security defined as security of personal information (Laws General Data Protection - LGPD) . For patients randomized to the in-person postoperative consultations arm, it will be applied an adapted questionnaire, based on QAS-Tele, in order to verify the degree of patient satisfaction in relation to their type of consultation and their interest in carrying out telemedicine consultations in the future.

Questionnaires will be administered to patients 5 to 10 days after the first post-operative return to evaluate the issues mentioned by members of the research team via telephone contact. In addition to this information, patients coming to the institution's emergency room will be quantified within a period of up to 30 days after surgery.

The secondary outcomes will be the number of unattended arrivals programmed at the institution, presence of postoperative complications graded according to the Clavien-Dindo classification, appointment's duration, number of exams requested by the attending physicians, total cost involved per service (expenses with travel, mobile internet data package, necessary structure to telemedicine services) and environmental impact generated with both types of services. Patients will have their demographic data and clinical conditions recorded in appropriate database using RedCap software (Sex, Age, index of body mass, classification of the American Society of Anesthesiologists, Charlson classification, Clavien-Dindo classification). The descriptive analysis will be made by reporting the quantitative variables through the mean, standard deviation, median and quartile, and statistical analysis performed using the Wilcoxon-Mann-Whitney.

Telemedicine for Postoperative Follow-up After Oncological Surgeries

Degree of patient satisfaction assessed by using a Likert scale with seven questions about the appointment quality and grading with five answers (definitely not, probably not, maybe, probably yes, definitely yes)

Number of unattended arrivals at the institution or emergency services

Presence of postoperative complications graded according to the Clavien-Dindo classification

Number of exams requested by the attending physicians in the post-operative return

Expenses with travel, mobile internet data package, necessary structure to telemedicine services

Environmental impact in the follow-up measured by carbon dioxide emission produced by the type of transportation and travel time.

Instituto do Cancer do Estado de São Paulo

Occupational Diseases

Occupational Stress

Burnout, Psychological

Stress, Psychological

Behavioral Symptoms

Each oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback.

Oncologists in the control group will conduct consultations as usual.

On-site supportive communication training

Kerstin Kiis Antonsen, MD

The goal of this randomized, controlled clinical trial is to test a new concept for communication skills training (on-site supportive communication training (on-site SCT) in cancer care. The study aims to determine the impact of on-site SCT on patients' rating of oncologists' communication abilities.

Oncologists participating in the study will be randomly allocated to the intervention or control group. In the intervention group each doctor will have a total of three intervention days at intervals of 3-4 weeks. On an intervention day, a psychologist will sit in and observe doctor-patient consultations. After the first consultations, 30 minutes are allocated for feedback to the doctor by the psychologist. After the last consultation of the day, 60 minutes are allocated for thorough feedback and establishment of learning goals to focus on until the next intervention day. Doctor's in the control group will conduct communication as usual.

Researchers will compare the control and intervention groups to see if patients' rating of doctors' interpersonal and communication skills increase when the doctors have participated in on-site SCT. The 15-item Communication Assessment Tool (CAT) will be used.

It will also be investigated whether on-site SCT increases the doctors' rating of themselves in relation to communication efficacy and job satisfaction and decrease their experience of burnout.

Oncologists carry a heavy responsibility when delivering information to cancer patients and helping them navigate through decisions about life-altering treatments, survivorship, and end-of-life care. Comprehensive person-centered psychosocial cancer care should be adapted to the individual patient, which is obviously a challenging task (Dilworth, et al. 2014). Individualized and empathic communication, on the other hand, is of substantial importance to patient satisfaction, adherence to treatment, empowerment, and the ability to navigate in the disease trajectory (Gattellari, et al. 2001; Stewart 1995; Vogel, et al. 2009).

The quality of the communication in medical care has been shown to influence health outcomes, as it increases the risk of unnecessary treatment and is linked to insufficient pain relief and higher anxiety levels (Thorne, et al. 2005). Therefore, considerable effort has been dedicated to interventions that may improve the communication skills of healthcare professionals involved in cancer care (Moore, et al. 2018). The primary purpose has been to improve the quality of the doctor-patient-communication including the doctors' interpersonal skills.

Previous papers have suggested direct feedback on observed situations as an ideal method for improving communication skills (Anderson 2012; Burgess, et al. 2020), but to the best of our knowledge, no randomized clinical trials have used patient feedback during on-site training. Studies on communication skills training courses with recorded consultations/role-play have shown significant effect on key communication skills (Fallowfield, et al. 2002) and increased self-efficacy (Ammentorp, et al. 2007). Two studies have demonstrated long-term maintenance of acquired skills (Finset, et al. 2003; Gulbrandsen, et al. 2013). Until now, no effect on burnout has been demonstrated (Bragard, et al. 2010a; Bragard, et al. 2010b).

Clinical supervision and training aims to develop clinical practice and provide a protected space to allow an educational and reflective process to occur. Although there is still no empirical definition of the term supervision (Milne 2007), in 2004 Bernard and Goodyear defined it as "an intervention provided by a more senior member of a profession to a more junior member or members of that same profession"(Bernard 2004). On this premise, psychologists cannot formally supervise doctors and other terms must be used. In this project we therefore use the term "on-site supportive communication training" (on-site SCT) when referring to the intervention given by the psychologists.

Psychologists have a long tradition of working with communication, creating a reflective learning space, making observations and providing feedback. It is therefore highly relevant to use dedicated psychologists to investigate the effect of on-site SCT on the doctors' communication and on their experienced level of self-efficacy, satisfaction and burn-out.

Oncologists will be randomized between the intervention and usual practice.

On-site Supportive Communication Training in Doctor-patient Communication

On-site Supportive Communication Training in Doctor-patient Communication: A Randomized, Controlled Trial

Patients rate the doctor's communication skills right after the consultation.

The Self-efficacy in Health Communication tool consists of 12 questions eliciting the healthcare professionals' perceived self-efficacy in communication with patients using a 10-point scale from "very uncertain" (1) to "very certain" (10).

The reply options in relation to burnout range from 1 (To a very high degree/always), to 5 (To a very low degree/never-almost never)

Job satisfaction is measured in Denmark every other year at the nation-wide employee satisfaction survey, which survey offers a large amount of comparable data. Five items directly concerning job satisfaction will be extracted from the survey.

Zealand University Hospital

Aalborg University Hospital

Vejle Hospital

Pain

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIVC application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. The vein imaging device will be opened with transilluminator, the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data obtained on PIVC placement; the pain and fear levels before, during and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

The patient's vital signs, skin color, and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse. Vein imaging will not be performed. No intervention will be carried out the tourniquet will be connected, and the vein visibility will be re-evaluated by the operator. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the PIVC. Data will obtained on PIVC placement; the pain and fear levels before, during, and after the procedure. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion.

Experimental group - Vascular imaging device with the infrared light group: Before PIVC, infrared light will be directed to the vein area and the procedure will be started after vein visibility is achieved.

Experimental group - Vascular access transillumination group: Before PIVC, a transilluminator will be inserted to the vein area and the procedure will be started after vein visibility is achieved

Vascular imaging

Yasemin Karacan, PhD

Türkkan Evrensel, Prof, PhD

Purpose: This study will be conducted on the effect of infrared light on PIVC procedure fear, procedure pain, and patient satisfaction in oncology patients receiving chemotherapy treatment. The investigators will implement the study during the insert on PIVC; the vascular imaging device with the infrared light group; the vascular access transillumination group; and the control group.

Design: This is a prospective, randomized controlled experimental study.

The population of the research will be cancer patients who applied to Bursa Uludag University Medical Faculty Hospital Oncology unit between June 2023 and July 2025. The population of the study will consist of patients who applied to the Chemotherapy Unit in Bursa Uludağ University Health Research and Application Center Hospital Oncology Polyclinic for outpatient treatment. It is aimed to reach all patients who agreed to participate in the study and who met the inclusion criteria of the study, rather than using the research sample selection method. However, this data does not show the number of patients who applied to the unit because of the repeated visits of the patients during the chemotherapy treatment process. For this reason, direct sample selection was not made in the study, and the sample calculation was made according to the number of patients registered in the unit and the results of previous research. Calculations were made using the "G.Power-3.17" program with 95% confidence, an effect size of 0.4, and a statistical test power of at least 80%. Accordingly, it was aimed to reach 126 patients, at least 42 in each group.However, since the losses will be ignored, it is aimed to reach 150 patients in total. The hypotheses of the research;

H0,1: In patients receiving chemotherapy, the vein imaging device has no effect on the successful PIVC procedure by determining the appropriate vein.

H1,1: In patients receiving chemotherapy, the vein imaging device has an effect on the successful PIVC procedure by determining the appropriate vein.

H2: Vascular imaging device has a lower value in terms of pain in the PIVC procedure in patients receiving chemotherapy.

H3: In patients receiving chemotherapy, the vascular imaging device has a lower level of fear in the PIVC procedure.

H4: In patients receiving chemotherapy, vascular imaging device is higher in terms of patient satisfaction in PIVC procedure.

Implementation of the study in the vascular imaging device with the infrared light group: The patient will be taken to the chemotherapy application chair and rested. The patient's vital signs, skin color and skin turgor will be evaluated and recorded in the PIVC procedure registration form. Since it is stated in the literature that the placement of the peripheral intravenous catheter in the unused arm is important in preventing complications, the PIVC procedure will be performed in the arm that the patient does not actively use. Before the tourniquet is attached before the procedure, the patient's vein visibility will be evaluated by the research nurse . The vein imaging device will be opened with infrared light, the tourniquet will be connected, and the vein visibility will be re-evaluated by the research nurse. As soon as the turnstile is connected, the stopwatch will be started. Then the PIVC placement process will be started with the help of the device. The skill duration will be measured and recorded by the researcher with a stopwatch. The selection of the necessary materials will not be added to this time, the chronometer will be started after the tourniquet is attached, and the time will end with the blood coming to the branule. If there is no blood, the attempt will be considered unsuccessful. In unsuccessful cases, the PIVC attempt will be repeated up to two times in each patient. All procedures will be performed by a single research nurse to ignore the operator hand manipulation difference. Data obtained on PIVC placement; Vein visibility, the catheter number used in the procedure, the time to identify the appropriate vein, the successful PIVC placement time, the number of attempts for successful catheter placement, the vein in which the catheter was placed, the pain and fear levels before, during and after the procedure. These data will be recorded in the data form regarding the PIK application. Finally, patients will be asked about their level of satisfaction with the procedure at the end of the infusion. The satisfaction levels in the form will be evaluated on a scale ranging from 0 to 10, with 0: none, 10: many, after the application. These data will be recorded in the data form on PIVC transaction satisfaction.

Implementation of the study in the vascular access transillumination group: The processes will be repeated exactly. Transilluminator will be used instead of infrared light.

Implementation of the study in the control group: The processes will be repeated exactly. No intervention will be made for vascular access.

This is a prospective, randomized controlled experimental study.

The intervention and measurements will carried out by the researcher (for hand manipulation standard) and the patients will discovered their own groups when intervention will applied to them. Because of the nature of the intervention, blinding will not be performed.

The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy

The Effect of Infrared Light Use on Pain, Fear, and Patient Satisfaction During Peripheral Intravenous Catheter (PIVC) Procedure in Oncology Patients Receiving Chemotherapy

Individual participant data (IPD) doesn't share any other researchers. Only research team will see data on IPD. After the data collection phase is completed and turned into a publication, other researchers can access the publication.

In this form, patients' satisfaction with the procedure will be evaluated using a visual comparison scale that can be graded from 1 to 10. It consists of questions created in line with the literature about how the nurse evaluates the patient's skills about the PIC procedure, how she evaluates your general PIC access experience, whether she sees herself as a patient with a history of DIFFICULT VASCULAR PATH, and whether the nurse who will perform PIC makes a comprehensive assessment of her veins (Eren and Çalışkan, 2021; Ramer et al., 2016). It includes minimum 0 point, maximum 10 points.

It is a one-dimensional scale used in the measurement of VAS pain. Among the one-dimensional scales used to determine the severity of pain in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Pain" and on the other end "Unbearable Pain" describing the most severe pain possible. The patient is asked to mark his pain on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

It is a one-dimensional scale used in the measurement of VAS fear. Among the one-dimensional scales used to determine the severity of fear in patients, it was determined that the VAS measures more sensitively and is more reliable. The scale consists of a 100 mm long horizontal line. On one end are the phrases "No Fear" and on the other end "Unbearable Fear" describing the most severe fear possible. The patient is asked to mark his/her fear on the scale.

The length of the line from the starting point of the scale to the point marked by the patient is measured and recorded in mm. It includes minimum 0 point, maximum 100 points.

Uludag University

Principal Investigator, PhD, Msc

Anxiety Disorders

Nausea

Mental Disorders

Psychotic Disorders

The patients in this group will listen to specially composed "MusiCure®" compositions, which contain melodies with soft rhythm (60-80 bpm), including harp, cello, strings, and nature sounds (such as rain, bird, forest sound). The patients scheduled to receive chemotherapy for the first time, will be allowed to listen to music for at least one hour during chemotherapy with over-ear headphones (Sennheiser HD280) and an MP3 player. Anxiety and satisfaction levels of the patients will be recorded before and after the music application.

The patients in this group will listen to the "Rast Makam", which was created as a result of research conducted by the Turkish Music Research and Promotion Group (TÜMATA) and provides individuals with comfort and inner peace. The patients scheduled to receive chemotherapy for the first time, will be allowed to listen to music for at least one hour during chemotherapy with over-ear headphones (Sennheiser HD280) and an MP3 player. Anxiety and satisfaction levels of the patients will be recorded before and after the music application.

The patients in this group will not receive any musical interventions and will receive standard treatment and care during chemotherapy.

Music

Chemotherapy is a treatment that uses natural or synthetic chemicals and biological agents to kill rapidly proliferating cells. As chemotherapeutic drugs prevent the growth and proliferation of cancer cells, they also inhibit the growth of normal cells such as intestinal and oral mucosal epithelium, bone marrow cells, and hair follicle cells. During chemotherapy treatment, which is widely used in the treatment of cancer cases and considered one of the most effective methods of cancer treatment, individuals; may experience side effects such as nausea-vomiting, loss of appetite, mouth ulcers, pain, fatigue, anxiety, depression, sleep problems, and changes in their skin and nails.

There are several factors that can trigger anxiety in cancer patients: fear of cancer and its treatment-related side effects, fear of relapse after treatment, uncertainty, concerns about changing roles and relationships, and fear of death. Treatment methods are available for a variety of side effects and negative effects experienced by cancer patients. These methods include pharmacological and nonpharmacological approaches. For example, benzodiazepines are frequently used to treat anxiety in cancer patients. If benzodiazepines are not adequate, low-dose antipsychotics can be used. However, benzodiazepines and their derivatives may reduce respiratory function, induce sedation, and cause confusion.

Music is an example of non-pharmacological cognitive-behavioral treatment that is used to control negative symptoms in many fields. The use of music for healing is easy, has no side effects, and is beneficial for physical, psychological, emotional, and spiritual well-being. Anxiety and fear can be reduced by therapeutic music, which increases endorphin secretion and positive emotions. Treatment of serious illnesses such as cancer requires a holistic approach that includes psychological, social, and spiritual support in addition to pharmacological treatment. Therefore, the purpose of this study is to examine how different types of music affect cancer patients' anxiety and satisfaction during chemotherapy.

The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels

The Effect of Two Different Types of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels

Baseline and post-intervention anxiety level assessed by trained research nurse using Spielberg's State-Trait Anxiety Inventory (STAI). The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety.

Baseline and post-intervention nausea level assessed by trained research nurse using VAS (0 to 10; 0 means no nausea,10 means severe nausea).

Post-intervention satisfaction level assessed by trained research nurse using VAS (0 to 10; 0 means not satisfied, 10 means very satisfied).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
Telemedicine for Postoperative Follow-up After Oncological Surgeries	NCT06282354	Urologic Cancer Satisfaction, P... Surgery Postoperative A...	Type of post-op...	18 Years -	Instituto do Cancer do Estado de São Paulo
On-site Supportive Communication Training in Doctor-patient Communication	NCT05842083	Communication P... Communication, ... Communication R... Oncology Doctor Patient ... Job Stress Burnout Satisfaction, P... Efficacy, Self	On-site support...	18 Years - 100 Years	Vejle Hospital
The Effect of Infrared Light Use in Oncology Patients Receiving Chemotherapy	NCT05892978	Pain Fear Needles Satisfaction, P...	Vascular imagin...	18 Years - 74 Years	Uludag University
The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels	NCT05687838	Anxiety Chemotherapy Ef... Satisfaction, P... Cancer Nursing Caries	Music	18 Years -	Uludag University
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
Decisional Conflicts, Health-related QoL and Satisfaction With Care in High-risk cSCC in the Head-neck Region	NCT05482880	Cutaneous Squam... Cutaneous Squam... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Skin Cancer High-Risk Cance... Quality of Life Satisfaction, P...	Regular care wi...	18 Years -	Maastricht University Medical Center
On-site Supportive Communication Training in Doctor-patient Communication	NCT05842083	Communication P... Communication, ... Communication R... Oncology Doctor Patient ... Job Stress Burnout Satisfaction, P... Efficacy, Self	On-site support...	18 Years - 100 Years	Vejle Hospital
The Effect of Music Applied During Chemotherapy on Anxiety, Nausea and Satisfaction Levels	NCT05687838	Anxiety Chemotherapy Ef... Satisfaction, P... Cancer Nursing Caries	Music	18 Years -	Uludag University

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