Neoplasms

All Conditions

Head and Neck Neoplasms

Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy

Each subject will be administered the appropriate surveys and blood draws over the course of the study.

Collect Blood and Survey Instruments

Jared Weiss, MD

To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.

Purpose: To identify baseline predictors of change in function over the course of treatment with chemoradiotherapy in patients with head and neck cancer.

Participants: Patients 65 or older who have an appointment at the North Carolina Cancer Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and neck cancer

Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They will also complete a health behavior questionnaire at baseline.

Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer

Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer

To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment.

To explore the association of baseline measures with time to decline in living status. (For example, completely independent to requiring home help, or requiring home help to moving to a nursing home, etc.)

To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.

To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.

To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment

To explore the association of baseline measures with change in IADL subscore.

UNC Lineberger Comprehensive Cancer Center

Nervous System Diseases

Rare Diseases

Meningioma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Participants are asked to check the symptoms that they have experienced in the last 6 weeks.

Participants are asked to un-check the symptoms that they have experienced in the last 6 weeks.

Participants are asked to check the symptoms that they have NOT experienced in the last 6 weeks.

Participants are asked to un-check the symptoms that they have NOT experienced in the last 6 weeks.

Check Symptoms

Uncheck Symptoms

Focus of instructions is on symptoms the participant has experienced

Experienced

Focus of instructions is on symptoms the participant has NOT experienced

Not Experienced

Eric M VanEpps, MS

Prevention and early detection of medical problems can greatly reduce health care costs, yet time and again, people avoid or ignore services that could help detect medical problems early enough to prevent or reduce the severity of potential problems. The investigators seek to understand whether the elicitation of symptom admission by patients can predict people's perceived risk of the medical condition and voluntary pursuit of medical information.

We will present individuals with medically accurate information about a medical condition and measure people's perceptions of their own likelihood to having that medical condition. This will include an opportunity for people to pursue more information by directing them to a website that features more information about the condition. The initial information provision will vary slightly in presentation (method of eliciting symptoms will vary), and the rate at which individuals visit the subsequent medical website to receive more information will be recorded as a measure of information seeking behavior. Rates will be compared across symptom elicitation conditions to determine which formats are most effective at encouraging information seeking about health issues. No personally identifying information will be collected, and all results will be reported in aggregate. Critically, no deception will be used: Participants will only be provided with information that is as accurate as possible (given existing knowledge in the health/medical fields).

Information Presentation Formats

Information Presentation Formats and Pursuit of Diagnostic Information

The number of symptoms checked off by participants

Self-reported perceived risk of meningioma

Binary measure of whether participants click to receive information about meningioma

Hypothetical federal funding allocation to meningioma

Perceived risk of having any serious disease

Carnegie Mellon University

PhD Candidate

Blood and Lymph Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Hematologic Diseases

Quality of Life

Intervention with

1. nurseled sexual consultations with screening questionnaire prior to consultation
2. genital examintaion with doctor

Sexual Health

Sexual wellbeing is an integral component of psychosocial and physical wellbeing. Cancer-related symptoms, treatment side-effects and psychosocial distress have significant impact on sexual well-being and sexual health. Within the framework of sexual wellbeing, sexual function is defined by a capacity to fully engage in all phases of the human sexual response cycle. Thus, sexual dysfunction is characterized by a disruption in one or more elements of the response cycle. Previous research shows that patients with hematologic malignancies and specifically patients following stem cell transplantation experience a high symptom burden and distinct genital alterations, and therefore in increased risk of sexual dysfunction. In spite of growing evidence documenting high prevalence of sexual dysfunction in cancer patients, patients with hematologic malignancies are underrepresented in clinical trials investigating their sexual health. This study aims to examine the sexual health in patients across hematologic malignancies in Denmark, and to investigate feasiblity and effect of a randomized multimodal intervention by providing nurse-led sexual consultations and physician-led preventive genital examinations, to enhance sexual function and early recognition of gential graft versus host disease in adult patients following hematopoietic stem cell transplantation. Finally, the study aims to explore perspectives and experiences of patients following this multimodal intervention. This knowledge will entail new opportunities to detect subgroups of patients with distinct risk of sexual dysfunction, and potentially lead to targeted interventions in clinical practice toward this specific population. Moreover this will provide evidence with high methodological rigor and potentially strengthen the possibilities for evidence-based decision making in Denmark regarding preventive gential examinations during follow-up in patients following stem cell transplant.

1. Introduction As the survival rates for hematologic malignancies improves there is subsequently an increased need for addressing long-term complications. The evidence highlight that patients experience a high symptom burden including sexual dysfunction, and therefore in increased risk of decreased sexual health. Sexual health is a state of physical, mental and social well-being in relation to sexuality, and can reduce the emotional distress and improve psychosocial response to a cancer diagnosis and complications following treatment. Still, this population is underrepresented in clinical trials investigating their sexual health. It is therefore essential to include them in future clinical trials in order to have a comprehensive view of their condition of sexual health and sexual function. This knowledge will entail new opportunities to detect subgroups of patients with distinct risk of sexual dysfunction, and this will potentially lead to targeted interventions in clinical practice toward this specific population.

   In patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) sexual dysfunction is one of the most frequent long-term issues. Sexual dysfunction include decreased libido, vaginal alterations, erectile and ejaculatory dysfunction, dysfunction in sexual hormones, dyspareunia and infertility. Specifically, an immunologic reaction in the skin tissue called genital graft versus host disease (GHVD), is a major determinant of sexual dysfunction in this population. Genital GVHD can lead to vaginal stenosis, scar tissue and adhesions in blood vessels, rash and increased sensitivity in the skin of the genitals. Despite increasing evidence on the clinical manifestations it is still an underrecognized and underestimated complication of HCST in clinical practice due to the nonspecific nature of presenting symptoms and low awareness of the condition. In a previous systematic review, the investigators concluded that multiple aspects of sexuality were affected following treatment with HSCT, and the impact and ethology of these sexual alterations were different between genders. Therefore, the investigators investigated the impact of HSCT on sexuality in a resent longitudinal survey. The results showed a significant decline in overall sexual function in both men and women. Still, most studies have solely investigated female genital GVHD, in small populations and only few have included evaluations of sexual function prior to HSCT. No previous studies have investigated the effect of a multimodal intervention specifically focused on evaluation of sexual function through nurse-led sexual consultations and early recognition of genital GVHD in patients during treatment with HSCT. Thus, further recognition of sexual symptoms and regular follow-up can possibly help to improve the detection and facilitate early treatment of sexual complications including genital GVHD. This will help our understanding in the development of systematic strategies to prevent or treat its long-term effects.
2. Hypotheses

   This study is based on the following hypothesis or assumptions:

   Study 1

   • The investigators hypothesize that patients with hematologic malignancies report impaired sexual function, and that sexual dysfunction are associated with high symptom burden, sexual distress, reduced quality of life and increased anxiety and depression.

   Study 2

   • The investigators hypothesize that a multimodal intervention with nurse-led sexual counseling and systematic gential evaluations is feasible and will enhance sexual function in patients undergoing HSCT
3. Aim The overall aim of this study is to investigate sexual health in patients treated for a hematologic malignancy, and to generate research-based knowledge on the feasiblity and effect of a multimodal intervention with nurse-led sexual counseling and systematic genital evaluation on sexual function in patients during their treatment with HSCT.

   The specific aims of the studies are:

   Study 1

   • To examine the sexual health in patients across hematologic malignancies in Denmark, and to examine the prevalence and factors associated with sexual dysfunction in this population.

   Study 2

   • To investigate feasibility and effect of a randomized multimodal intervention with nurse-led sexual counseling and systematic genital evaluation on enhancing sexual function in patients undergoing HSCT.
4. Study description study 1 4.1 Aim To examine the sexual health in patients across hematologic malignancies in Denmark, and to examine the prevalence and factors associated with sexual dysfunction in this population.

   4.2 Design and methods This study is an explorative cross-sectional national study examining sexual health across different haematological malignant diseases in Denmark.

   4.3 Participants Participants with haematological malignant diseases specifically acute myeloid leukemia (AML), acute lymphatic leukemia (ALL), chronic lymphatic leukemia (CLL), chronic myeloid leukemia (CML), multiple myeloma, non-Hodgkin lymphoma, Hodgkin lymphoma, are eligible if \> 18 years with time post diagnosis \> 3 month up to 10 years. Participants are excluded if they are unable to read or speak Danish or have a cognitive disorder.

   4.4 Recruitment and procedure Eligible participants will be identified through the National Patient Register. Then, the Danish Health Data Authority will be applied to extract a representative sample from the full potential eligible participants. This sample will be based on statistical measurements to achieve high statistical power. Eligible participants will receive information about the study, provide written informed consent and receive the questionnaires electronically through e-boks.

   4.5 Data collection

   Participant and disease characteristics will be obtained from the participants. These will include age, gender, marital status, education, employment status, disease type and status, type and intensity of treatment received, and treated hospital. The patient-reported outcome measure (PROM) include:
   * Sexual health will be assessed by the Female Sexual Function Index (FSFI) in female participants. FSFI is a brief 19-item self-report measure of female sexual function that provides scores on six domains: desire, arousal, lubrication, orgasm, satisfaction and pai. In male participants, sexual health will be assessed by The International Index of Erectile Function Questionnaire (IIEF). IIEF is a brief 15-item widely used multi-dimensional self-report instrument for evaluation of male sexual function that proves scores in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
   * Sexual distress will be assessed by the Female Sexual Distress Scale - Revised (FSDS-R). FSDS-R is a 13 item measure assess sexual distress specifically related to low sexual desire. The scale has been developed for use in female patients but have recently been validated in male patients with excellent internal consistency and test-retest reliabilities.
   * Quality of life will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30). EORTC-C30 is a 30 item multi-dimensional quality of life measure designed for use in cancer patients.
   * Symptom burden will be assessed with M.D. Anderson Symptom Inventory (MDASI) which is a 19 item measure and assesses the severity of 13 symptoms and their impact in cancer patients.
   * Psychological well-being will be assessed and measured by using the Hospital Anxiety and Depression Scale (HADS), which is a brief 14-item self-report measure of anxiety and depression.

   4.6 Analysis Statistical analysis will be conducted using IBM SPSS Statistics for Windows, version 25. Throughout, two-sided P-values \<0.05 confidence intervals are considered indicators of statistical significance.
5. Study description study 2 5.1. Aim To investigate feasibility and effect of a randomized multimodal intervention with nurse-led sexual counseling and systematic gential evaluation on enhancing sexual function in patients undergoing HSCT.

   5.2 Design and methods This study is a prospective two-arms randomized controlled trial to assess the feasibility and effect of a multimodal nonpharmacological intervention to address sexual health in patients undergoing HSCT.

   5.3 Participants Patients (age\>18 years) with a hematologic malignancy who is planned to undergo an HSCT, who provide informed written consent and can understand, speak and read Danish are eligible to participate. The exclusion criteria include patients with dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation.

   5.4 Recruitment and procedure Patients will be recruited from the Department of Hematology, Rigshospitalet. Eligible participants receive oral and written project information from primary research investigator (KHN) during their preexamination week prior to HSCT. Patients will be informed about the trial, perceived benefits, risks, and safety precautions, and about their personal rights in entering the trial. Study participants who complete baseline questionnaires are then randomized, and participants in the intervention group will be scheduled for their first assessment.

   Randomization and blinding Patients included in the study will be randomized 1:1 ratio to either the intervention group or control group (usual care) by KHN. Randomization and stratification (age, diagnosis) will be performed through the randomization module in Redcap. Because it is not feasible, the primary investigator and the patient will not be blinded to group allocation. However, to reduce the risk of detection bias, the investigator will be blinded to group allocation during data entry. Moreover, the statistician will be blinded to allocation during data analysis. The identity of each patient will be masked and can only be re-identified using a separately kept key file.

   Usual care Patients allocated to control group will receive usual care which include genital evaluation during their preexamination week prior to HSCT. During the treatment trajectory genital examination is conducted when genital symptoms are reported either by the health care provider or the patient. Patients in the control arm will receive a final assessment with genital evaluation and nurse-led sexual counseling. Data collection with PROM will be conducted prior to the final genital evaluation and nurse-led sexual counseling.

   5.5 Multimodal Sexual Dysfunction Intervention The intervention consists of nurse-led sexual counselling and systematic genital evaluation (Figure 1). The intervention begins during their preexamination week prior to HSCT and the subsequent 18 months.

   Nurse-led sexual counseling The intervention entails five nurse-led sexual counseling sections. Participants will attend their first nurse-led sexual counseling session three month post HSCT with KHN who is an experienced HSCT nurse. The patients will fill out the PROMS related to GVHD and sexual function as a screening tool which guide the counselling session and the subsequent genital evaluation. The counselling consists of guidance and follow-up on relevant issues related to disease and treatment sexual complications including genital GVHD. The first intervention visit will be conducted in-person in the outpatient clinic. Subsequent visits can be conducted in-person or over the telephone. Participants with complex sexual health concerns will be referred to the Sexual Health Clinic at Rigshospitalet for further evaluation.

   Genital evaluation Female patients will have a baseline gynecological review with a specialist experienced in post-transplant gynecological care during their preexamination week. During the intervention the patients will have 5 preventive control visits which include a through genital examination and evaluation including menopausal symptoms, genital GVH, and genital tract malignancies.

   Male patients will have a baseline urological review with a specialist experienced in post-transplant urological care. During the intervention the patients will have 5 preventive control visits, and the consultation will include a through genital examination and evaluation including genital GVHD.

   5.6 Data collection

   Participant and disease characteristics will be obtained from the participants. These will include age, gender, marital status, education, employment status, disease type and status, type and intensity of treatment. The patient-reported outcome measure (PROM) include:

   Primary outcome

   • The primary outcome is sexual function which will be assessed by FSFI in female participants, and in male participants by IIEF.

   Secondary outcomes
   * Feasibility of the intervention will be evaluated as acceptability, practicability, integration, adherence to protocol, resource utilization and safety.
   * Sexual distress will be assessed by the FSDS-R.
   * Symptoms of genital GVHD will be assessed by specially developed questions based on clinical and experienced manifestations of genital GVHD.
   * Symptoms of GVHD in other organs will be assessed by the chronic GVHD symptom scale. The scale contains 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological), and patients report their level of symptom over the past month.
   * Quality of life will be assessed by EORTC-C30.
   * Symptom burden will be assessed with MDASI. 5.7 Analysis Study feasibility parameters will be described and analyzed using descriptive statistics. The demographic and clinical characteristics of participants will be summarized in percentages for categorical variables and mean (SD) for noncategorical variables. Mean score will be calculated for each group and compared using student´s t-test. The domains of questionnaires will be calculated for each group and compared using Wilcoxon´s rank-sum test. Throughout, two-sided P-values \<0.05 confidence intervals are considered indicators of statistical significance. Statistical analysis will be conducted using IBM SPSS Statistics for Windows, version 25.

   Sample size
   * In female patients, assuming a difference of size 2.1 for the primary outcome (FSFI) between intervention and control group and a standard deviation of 3.86 points for the primary outcome within each group and with a two-sample t-test with a power of 80 % to detect a significant difference at level 0.05 if 55 patients are included in each treatment arm. To account for an expected dropout rate of 20 % the investigators decided to increase this number to a group size of 66.
   * In male patients, assuming a difference of size 5.0 for the primary outcome (IIEF) between intervention and control group and a standard deviation of 9.3 points for the primary outcome within each group and with a two-sample t-test with a power of 80 % to detect a significant difference at level 0.05 if 56 patients are included in each treatment ar. To account for an expected dropout rate of 20 % the investigators decided to increase this number to a group size of 67.

   There is yearly around 95 patients receiving HSCT at Department of Hematology, Rigshospitalet. Based on this and an expected acceptance of 75%, the investigators aim to include 133 patients in each arm of the study, and therefore the project is estimated to run for 42 months, starting fall 2021.
6. Ethical considerations This study will be registered with the Danish Protection Agency and Clinical Trials. Each participant will receive written and verbal information on the study and assurance of confidentiality according to the principles for research stated in the Helsinki Declaration. Written consent will be obtained from patients participating at time of recruitment. Awareness of the informant's vulnerability mean that additional attention will be paid to the voluntariness in their participation, just as they are given time to debrief and further discuss their experiences.
7. Setting Department of Hematology, Rigshospitalet, Denmark will be Primary sponsor for this project. KHN will be principal investigator of all studies in collaboration with the research management group, the national and international research collaborators (mentors) and clinical collaborators who all have agreed to participate in the study (Figure 2, Table 1).

Sexual Health in Patients With Hematologic Malignancies

Sexual Health in Patients With Hematologic Malignancies - Symptom Assessment and Management

The primary outcome is sexual function which will be assessed by Female Sexual Function Index FSFI in female participants

The primary outcome is sexual function which will be assessed by The International Index of Erectile Function Questionnaire IIEF in male patients

Feasibility of the intervention will be evaluated as acceptability measured by the rate of included participants, the dropout rate and the rate of completing participants

Feasibility of the intervention will be evaluated as practicability measured by logistics or other circumstances challenging adherence during intervention

Feasibility of the intervention will be evaluated as integration measured by an evaluation of the intergration of the intervention in the clinical praticice and daily work

Feasibility of the intervention will be evaluated as resource utilization measured by the total amount of time pr patient of nurse konsultation hours including preparation, and of doctor consultation

Feasibility of the intervention will be evaluated as safety measured by unexpected adverse events

Sexual distress will be assessed by the Female Sexual Distress Scale - Revised (FSDS-R) with higher scores indication higher sexual distress.

Symptoms of genital GVHD will be assessed by specially developed questions based on clinical and experienced manifestations of genital GVHD.

Symptoms of GVHD in other organs will be assessed by the chronic GVHD symptom scale. The scale contains 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological), and patients report their level of symptom over the past month

Quality of life will be assessed by by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30) with higher scores indicating better quality of life.

Symptom burden will be assessed with M.D. Anderson Symptom Inventory (MDASI) which is a 19 item measure and assesses the severity of 13 symptoms and their impact in cancer patients

Rigshospitalet, Denmark

Clinical Nurse Specialist, PhD

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Heart Diseases

Heart Defects, Congenital

Congenital Abnormalities

Cardiovascular Abnormalities

Patients uses the symptom assessment tool SiSom. A summary of their reported symptoms are printed out and given to the pediatrician and nurse before the consultation. The consultation is videotaped.

The control group do not use the symptom assessment tool "SiSom" before the consultation. The control group receives usual care and the consultation is videoptaped.

SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.

SiSom

Cornelia M Ruland, PhD

Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.

This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations:

* Children and parents will experience less anxiety.
* Children and parents will be more satisfied with the outpatient visit.
* There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.

To better understand the mechanisms by which these effects may occur, the investigators will also explore:

* Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed;
* The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions.

Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians.

For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.

Supporting Patient Provider Communication in Paediatric Care

Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease

The Research Council of Norway

Oslo University Hospital

Professor

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Participants get access to the eHealth application InvolveMe

An eHealth application that allows participants to report symptoms and needs prior to out-patient visits at the hospital. The application creates a summary that allows patients to prioritize what is important to talk with their health care providers about. Health care providers can use the summary to prepare the consultation.

InvolveMe

Elin Børøsund, PhD

The purpose with this study is to test a digital patient-provider communication tool for symptom and needs management among patients with chronic health conditions.

Living with chronic health conditions affects all areas of life. Fatigue, sleeping problems, pain and loneliness are common. In addition to troublesome symptoms that vary in intensity, many experience worry and uncertainty. There is a need to improve the quality of follow-up of patients with chronic health conditions. A digital patient-provider communication tool, which supports shared decision making, can be one way to improve quality.

The digital tool (InvolveMe) will provide patients with the opportunity to complete and submit a symptom and need assessment prior to out-patient visits at the hospital. Also, patients will have the opportunity to use secure e-mail for follow-up from health care providers in between hospital visits. The assessment will allow patient to prioritize what is important to talk with their health care providers about.

Such a tool can help to make changes in symptoms more visible to both patients and health care providers, as well as make it easier to ask for information and guidance to deal with the individual difficulties patients' experience. The goal is to better address symptoms and concerns and to enhance follow up and coordination between consultations as well as increase the quality of life and reduce illness related stress.

The digital communication tool will first be tested in a feasibility pilot study. The tool will be offered to 50 patients (kidney transplant recipients and patients with non-functioning pituitary adenomas). Participants will be given the opportunity to use the digital communication tool with baseline measures and following measures after 3 and 6 months.

After pilot testing of the tool, a larger longitudinal clinical study among 160 patients with non-functioning pituitary adenomas (n=60) and kidney transplant recipients (n=100) will be conducted to assess the clinical utility. The participants will be assigned to use the digital communication tool, and will be followed with repeated measures over 12 months.

All participants get access to the ehealth application

Implementing eHealth Interventions Into Regular Clinical Practice

Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement

10 item scale measuring system usability. The scale has a total score with a range from 0 to 100. Higher scores indicate higher system usability.

36 item scale measuring health related quality of life (HRQoL). The scale has 8 subscales and 1 single item score. Scale and single item range: 0 to 100. Higher scores indicate higher HRQoL.

14 item scale measuring anxiety and depression. The Scale has a total score with a scale range of 0 to 42 and an anxiety (HADS-A) and a depression (HADS-D) subscale, both with scale range of 0 to 21. Higher scores indicate higher level of anxiety and depression

44 item scale measuring health literacy. The scale consists of 9 subscales that covers distinct areas of health literacy. The scores for the first 5 scales range from 1 to 4, and the scores for scale 6-9 range from 1 to 5. Higher scores indicates better health literacy.

Norwegian Nurses Organisation

Head of Research and Education

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Symptoms and General Pathology

Breast Neoplasms

Arthralgia

Breast Diseases

Skin Diseases

Joint Diseases

Pain

Neurologic Manifestations

Antineoplastic Agents

All Drugs and Chemicals

Anastrozole

Aromatase Inhibitors

Breast cancer patients assigned to one or two groups: Group 1) enrolled at beginning of anastrozole treatment; or Group 2) if beginning third year of anastrozole treatment.

Questionnaires about pain and other symptoms, quality of life, and ability to work will be completed.

Questionnaire

A telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes.

Phone Calls

Charles Cleeland, PhD

The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.

Study Groups:

If you agree to take part in this study, you will be assigned to one of two groups, depending on how long you have been receiving anastrozole treatment. If you are within two months prior to or one month after starting treatment, you will be assigned to Group 1 and you will be followed through 2 years of treatment. If you have been taking anastrozole for about 2 years, you will be assigned to Group 2 and you will be followed through your third year of treatment.

Study Procedures:

You will complete tests and procedures during your regularly scheduled clinic visits.

Assessment 1:

* You will be taught how to use an automated symptom assessment program. For this program, a telephone system will call you at your home at a time that is convenient for you. Using the numeric key pad on your telephone, you will rate your pain and how it interferes with your daily activities.
* You will complete questionnaires about your pain and other symptoms, quality of life, and your ability to work. Completing the questionnaires should take about 45 minutes.
* You will also complete some cognitive (mental) questionnaires that should take about 30 minutes to complete. The cognitive questionnaires will be given to learn about problems with attention or mental fatigue that may be related to your treatment. If you choose not to complete the cognitive questionnaires, you can still participate in this study.
* Blood (about 2 ½ tablespoons) will be drawn to learn about how certain proteins called cytokines (found in the blood) change during therapy. Researchers will also measure the C-reactive protein (CRP) which indicates whether there is inflammation in your body.
* You will have an exam of your bone joints and you will be shown how to perform a self-exam on your joints at home using a study joint pain kit. This kit will be mailed to you if you have a new joint pain.
* Demographic information (name, address, date of birth, weight, height, marital status, job status, education, medical insurance status, and race) will be collected.
* Participants in Group 2 will complete a medication adherence questionnaire. This questionnaire contains questions about the dose of anastrozole you are taking, if it has changed (increased or decreased), and if you have been given any drugs to help manage symptoms that you may be experiencing. This form should take about 5 minutes to complete.
* If your doctor in the breast clinic thinks you need to see a specialist because of the pain or swelling you are experiencing, you will be referred to a rheumatologist here at MD Anderson. The rheumatologist will perform a bone joint examination and may order a blood draw to test for inflammation in your body.

Telephone System Calls:

The telephone system will call you every 2 weeks at a time convenient to you so that you can rate your pain and how it interferes with your daily activities. Each phone call will take about 5 minutes to complete.

While you are on the study, if you report through the telephone system joint pain of a certain level of severity, a joint pain kit will be mailed to you along with a pre-addressed stamped envelope. Study staff will call you to let you know the kit is being mailed and that they can help you complete it, if needed. You will be asked to perform a self exam of your joints and to mark the area that is painful to you on the body drawing included in the kit. You will also answer some questions about your pain and about your medication and supplement use. You will be asked to return the completed kit to the project office in the pre-addressed stamped envelope included with the kit. This kit should be able to be completed in about 15 minutes.

Every Month:

The study coordinator will call you monthly at a time convenient to you so that you can rate your symptoms and how they interfere with your daily activities.

Every 4 - 6 Months:

Research staff will arrange to meet you at your regularly scheduled clinic visits. These visits will take about 45 minutes. At these visits, you will have the following exams:

* Demographic information (marital status, job status, education, weight, and medical insurance status will again be collected.
* Blood (about 2 ½ tablespoons) will be drawn for cytokines and CRP testing.
* You will be asked to complete some questionnaires about your symptoms, ability to work, and quality of life.
* All participants will repeat the medication adherence questionnaire.
* A brief exam of your bone joints will be performed by the research staff.
* You will be asked to tell researchers about any changes in the medications, both prescribed and over the counter, and supplements you may be taking.

Annual Visits:

At your regularly scheduled annual visit (up to 2 times while on study), you will complete the following tests:

-If you agreed at the beginning of the study, you will complete the cognitive questionnaires. This should take about 45 minutes to complete.

The entire study-related time you will spend at your annual visit will be about 1 hour and 30 minutes.

Research staff will also collect clinical information and test results from your medical record while you are on study.

Length of Study:

Participants in Group 1 will remain on the study for up to 2 years. Participants in Group 2 will remain on the study for 12-14 months, depending on how follow-up clinic visits are scheduled.

This is an investigational study. Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.

Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors

AstraZeneca

M.D. Anderson Cancer Center

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Mouth and Tooth Diseases

Depression

Colorectal Neoplasms

Prostatic Neoplasms

Depressive Disorder

Leukemia

Melanoma

Mouth Neoplasms

Neurobehavioral Manifestations

Behavioral Symptoms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Standard care. Standard supportive care and Toolkit given at 12 weeks.

Interactive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study.

Interactive Voice Response (IVR) Reminders daily for the first 8 weeks of the study.

Interactive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8.

Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.

Interactive Voice Response (IVR) Reminders

Barbara Given, PhD

Charles Given, PhD

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of this study are to improve adherence to oral chemotherapeutic medications and self-management of symptoms among cancer patients. More than 40 oral agents currently are on the market with projections that in three years 30% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects.

This longitudinal randomized trial tests and compares 'two strategies' for improving patient adherence to their oral cancer medication prescriptions to standard care. Both strategies incorporate symptom management support using an interactive voice response system (IVR) for symptom assessment and a printed evidence-based Medication Management and Symptom Management Toolkit (Toolkit) with helpful strategies and information for symptom management.

We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this study. Recruiters will identify patients as they are prescribed oral cancer medications, present the study to the patient, and ask them to consent to be part of the study.

Study Aims Following are the Aims of the study.

1. Cancer patients assigned to the intervention will have greater adherence to their prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained effect).
2. When compared with patients receiving weekly assessments only, patients receiving weekly assessments plus daily adherence reminders and printed symptom management strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at weeks 5-8, and at 12 weeks.

Two exploratory aims are assessed:

1. To test how patient characteristics (age, sex, depression), dose variation, symptom severity, and concurrent infusion therapy moderate the impact of the novel intervention on adherence at 4, 8, and 12 weeks.
2. To test the impact of the novel intervention on dose alterations, emergency department visits and hospital admissions over the 12 weeks in order to support the translation of this system into oncology practices.

Design and Methods A unique feature of this study is that assessments, reminders, and symptom management strategies will be delivered by an Interactive Voice Response system (IVR). This system has been tested in a previous trial and in a pilot study of medication adherence; it received high satisfaction ratings from patients.

All patients will complete intake (baseline), 4 week, 8 week, and 12 week interviews for symptom severity, depression, beliefs about oral agents, self-efficacy, and pill count. Following the intake interview a computerized procedure will randomize patients to one of two groups: experimental and control. Patients in both arms will receive 12 weekly assessments of adherence to their oral cancer medications and symptom severity delivered by the IVR.

In addition, patients in the experimental group will receive daily reminder calls for 4 weeks delivered by the IVR. At the end of week 4 patients will be offered the option to reduce calls to every other day, or continue with daily reminders for weeks 5-8. Reminder calls will be tailored to the cycle of each medication. Daily reminder calls include a question to determine if medication changes have occurred. If this occurs, reminder calls are stopped and/or adjusted to the revised prescription. Patients in the experimental group will be mailed a Toolkit. Patients who report symptoms above designated thresholds during a weekly assessment call will be referred to the Toolkit to assist with self-management.

The control group will not receive IVR reminder calls during the first 8 weeks. Control group patients, who report difficulty taking their cancer medications as prescribed, will be randomized following the 8 week interview to either receive 4 weeks of daily IVR reminder calls during weeks 9-12, or to continue in the control group. Patients randomized to receive daily IVR reminder calls will receive a Toolkit following randomization (and if during their weekly assessment calls they report symptoms above designated thresholds they will be referred to the Toolkit to assist with self-management). Patients randomized to continue in the control group will receive a Toolkit upon completion of the 12 week interview.

Medical records will be audited for oral cancer medication changes during the study period as well as adverse toxic events noted, and scripts written.

Implications \& Impact This research will identify and explore the factors (symptom severity, medication complexity, patient characteristics) affecting adherence to oral cancer medications and how symptom management might improve levels of adherence. This will allow patients to engage in their care and potentially transform the safety and quality of cancer care for patients on oral cancer medications.

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Individual participant data will not be made available.

this assesses the ability to believe that they can adhere

The Given Symptom assessment tool is used

This is an adaptation of the Cleeland Interference scale

We use the PROMIS physical function measure

This captures the use during the 8 weeks and is Emergency room use and hospital admissions including length of stay.

National Cancer Institute (NCI)

Michigan State University

University Distinguished Professor

Dyads will receive mailed print education materials regarding healthy lifestyle (nutrition and physical activity) disseminated by ACS and NCI. They will also receive 12 weekly phone calls to assess post-treatment related symptoms.

Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.

Dyads will receive 12 weekly phone calls to assess symptom management.

Symptom assessment only

Survivor and caregiver dyads will work together with a coach to establish diet and physical activity change SMART goals. Motivational interviewing based weekly coaching sessions will review symptom management and goal attainment and then enact strategies to modify goals to be more relevant and achievable.

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Spots Global Cancer Trial Database for symptom assessment