Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Routine distress screening will be conducted using the Distress Thermometer (DT) and an accompanying problem list. Participants will complete the screening tool before their consults with oncologists and the results will be stored in their medical records. During the consult, oncologists will review the DT scores and problem list with each participant to provide the corresponding educational materials, advice or referrals. Highly distressed participants may be referred by oncologists to the supportive care nurses (SCN) for further triage and review.

No routine distress screening will be performed.

Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.

Supportive and survivorship care program

Usual care

Alexandre Chan, PharmD

Alexandre Chan, Pharm.D

In Singapore, cancer patients are not consistently assessed for unmet survivorship care needs and systematically identified for subsequent referral to useful care services. To address this gap, a preliminary multidisciplinary program is developed to (i) routinely screen and identify cancer patients with high distress levels, and (ii) provide appropriate care referrals after a systematic review by a supportive care nurse.

This study hypothesized that breast and gynecological cancer patients receiving timely screening for distress and appropriate supportive care services will report better improvement in quality of life as compared to non-recipients under usual care. This pilot study then aims to evaluate:

(i) The effectiveness of the program on a patient level in improving the quality of life and the symptom burden of patients requiring further supportive services.

(ii) The feasibility of the program's implementation on a health-system level among breast and gynaecological cancer patients in the outpatient oncology clinics at a specialty cancer centre.

A cluster randomized controlled trial will be conducted at the National Cancer Centre Singapore (NCCS) over a period of 2 years. Eligible participants and their caregivers where applicable will be recruited and followed-up for a period of 12 months. Patients in the intervention arm will receive routine distress screening and referral to a supportive care nurse service where necessary; whereas patients in the control arm will receive usual care.

Patients' quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and compared longitudinally between both study arms at a 3-months interval. Additionally, physical and psychological symptom distress levels will be compared using the Rotterdam Symptom Checklist (RSCL).

For patients who receive symptom-specific services, additional questionnaires will be completed before and after they have received the service. They include the following: Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for fatigue, Patient Neurotoxicity Questionnaire (PNQ) for neuropathy, Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog v3.0) for cognitive function, and Patient-Reported Arthralgia Inventory (PRAI) for arthralgia.

An economic evaluation will be conducted using healthcare resource utilization and cost data gathered from health records and surveys including the Work Productivity and Activity Impairment (WPAI) questionnaire. Process outcomes of the program delivery will also be obtained to assess its feasibility by monitoring the referral patterns to supportive care nurse and adherence to screening or appointments. Lastly, patient satisfaction and clinicians acceptability of the program will be assessed via questionnaires.

Results from this study on the program's feasibility and effectiveness among breast and gynecological cancer patients are crucial to highlight potential implementation barriers and utility for patients before extending to other cancer types. Furthermore, results can shed a light on the program's scalability for future integration into routine care. This compelling initiative will contribute to the institution of integrated and coordinated rehabilitative and specialized clinics services to address supportive and survivorship needs of cancer patients across the continuum in the long run.

In this cluster randomized study, a cluster unit is defined as the clinic held by the individual oncologists who are treating eligible patients. The randomization schedule will allocate the cluster units (i.e. each oncologist and their clinic) in a 1:1 ratio to either the new supportive and survivorship care program or usual care arm. Therefore, all participants who received care from the same oncologist will have the same allocation.

Accessible Cancer Care to Enable Support for Survivors Programme

Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) assesses cancer patients' health-related quality of life for the past week. The global quality of life status scale will be used and it is scored from 0 to 100 where a higher score is indicative of better functioning.

Difference in quality of life scores assessed by EORTC QLQ-C30 will be tabulated for each patient. For each subscale, a medium improvement and deterioration in the longitudinal scores are defined and the proportion of patients who achieved the improvement or deterioration will be tabulated.

The physical domain of the Rotterdam Symptom Checklist (RSCL) comprises of 23 items and the psychological distress domain comprises of 7 items. Patients will rate each item/ symptom on a 4-point Likert scale ("not at all", "a little", "quite a bit" and "very much"). A higher domain score indicates higher distress levels and symptom burden.

The Singapore Caregiver Quality of Life Scale (SCQOLS) is a validated, multi-domain quality of life measurement scale. The five domains consist of: physical well-being, mental well-being, experience and meaning, impact on daily living and financial well-being. A total QOL score will also be tabulated. A higher score in each domain and the total score will indicate better performance and quality of life respectively.

The Multi-dimensional Fatigue Symptom Inventory-Short Form (MSFI-SF) consists of 30 items to assess 5 dimensions of fatigue: physical, general, emotional, mental and vigour26. Respondent will rate each statement on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely").

The Patient Neurotoxicity Questionnaire (PNQ) is a self-administered instrument designed for patient-based assessment of chemotherapy-induced peripheral neuropathy. It consists of two items that identify the incidence and severity of the sensory and motor disturbances. The severity will be rated from grade A to E with increasing severity. Also, patient will indicate the daily living activities that were interfered by chemotherapy treatment.

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog v3.0) consists of 37 items to assess subjective cognitive function in the following 6 domains: memory, concentration, mental acuity, verbal fluency, functional interference and multitasking. Two other subscales included are "noticeability" of cognitive changes and "effect of perceived cognitive impairment on quality of life". Respondent will rate the frequency of occurrence of each item in the past week on a 5-point Likert scale from 0 ("never") to 4 ("several times a day"). A higher domain or subscale score indicating better perceived cognitive functioning.

The Patient-Reported Arthralgia Inventory (PRAI) consists of 16 items to measure arthralgia severity in 8 joint pair groups. Respondent will rate the pain severity at each joint for the past week using a 11-point Likert scale from 0 ("none") to 10 ("as bad as you can imagine"). The total score will be a sum of ratings for all items and range from 0 to 160 where a higher score indicates greater arthralgia severity.

Patient acceptability questionnaire is adapted from the literature. Patients will rate the various processes in the program based on perceptions of the screening process, consult with supportive care nurse to discuss problems and the adequacy of information provision.

The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-item patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to a specific health condition (cancer status) for the past week.

Information on outpatient visits, hospitalizations, and healthcare-related resources will be extracted from participants' medical and billing records.

National Cancer Centre, Singapore

National University of Singapore

Associate Professor

caregivers of pediatric patients with cancer and other serious illnesses

pediatric patients with cancer and other serious illnesses

Lori Wiener, Ph.D.

Maryland Pao, M.D.

NIH Clinical Center Office of Patient Recruitment (OPR)

Background:

- Medical problems and treatments can cause stress in some people. Researchers want to learn more about how to measure distress in young people with medical illnesses. A screening tool called Checking In will be developed in order to help researchers find ways to identify concerns and stresses common to this group.

Objective:

- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.

Eligibility:

- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.

Design:

* Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks about mood, pain, fatigue, peer relationships, and sleep. During this phase, participants will be asked about the wording of the questions in Checking In. They will also talk about what they thought of the questions and if they understood them.
* Phase 2 will not involve participant enrollment. During this phase the researchers will be working with technologists to develop the software for an electronic version of Checking In.
* Phase 3 participants will complete an electronic version of Checking In. Researchers will ask questions about the ease or difficulty of using an electronic screen.
* Phase 4 participants and one of their caregivers will complete an electronic version of Checking In. They will also complete other questionnaires related to mood, pain fatigue, peer relationships and sleep. They will be asked their thoughts about using Checking In. On the same day, their NIH doctor will get summary data about their questionnaire answers. The doctor will also provide feedback about the summary form.
* Researchers will compare data from Checking In with data from the other questionnaires.

Objective:

The purpose of this study is to develop and implement Checking In, a brief and interactive screening measure of distress, designed to identify emotional, physical, social, practical and spiritual concerns of pediatric patients. An accompanying provider summary sheet that delineates patient report of distress, will allow providers to triage services to patients and their families, thereby enhancing patient quality of life throughout the treatment trajectory.

Objective 1: The primary objective of this protocol is to develop a brief electronic screening tool, Checking In, which would assist clinicians in assessing the presence of psychological distress in children and adolescents with cancer and other serious medical illnesses. In order to accomplish this aim, the researchers will conduct cognitive interviews with 60 pediatric patients in order to refine the questions and phrasing of items on Checking In. The results from this phase of the study of will be used to develop the electronic screen, which will be used to accomplish the remaining aims.

Objective 2: To assess the feasibility of administering Checking In to pediatric patients and their caregivers. Researchers who administer Checking In will complete a brief questionnaire rating the feasibility of administration and all barriers encountered.

Objective 3: To assess the feasibility of completing the Checking In screening tool among pediatric patients with cancer and other serious illnesses and their caregivers. This aim will be achieved by having the patients and their caregivers answer a brief questionnaire that assesses how feasible and acceptable they found Checking In to complete.

Objective 4: To establish the utility of the Checking In summary report. Providers will complete a survey evaluating the usefulness of the summary report to indicate whether: 1) the report provided useful information, 2) the information was presented in a userfriendly manner, and 3) the summary report impacted care planning for the child.

Objective 5: To assess the concurrent validity (i.e. the extent to which a test correlates with other previously validated measures of similar constructs) of Checking In as compared to validated measures of psychological symptoms (i.e. depression, anxiety, pain and fatigue) in patients with pediatric cancer, Neurofibromatosis Type 1 (NF1) or Primary Immune Deficiencies (PIDs).

Secondary Objective 1: To compare patient and caregiver ratings of Checking In in order to determine agreement rates.

-Study Population:

Outpatients, ages 8-21, enrolled in a research study either at the Pediatric Clinic or the

Primary Immune Deficiency Clinic at the NIH with a diagnosis of pediatric cancer, NF-1

LiFraumeni or PIDs will be invited to participate in this study. Additionally, outpatients

ages 8-21, receiving active cancer treatment or follow-up at Johns Hopkins, Children s

Hospital Colorado, or Levine Children s Hospital will be invited to participate.

-Design:

The initial phase of this study will consist of the researchers conducting cognitive interviews with 60 patients in order to refine the questions and phrasing of items on Checking In. Preliminary questions for Checking In were derived and modified from the PI s previous protocol on the Distress Thermometer. During this first phase, a paper and pencil version of Checking In will be used.

Results of this initial phase will be used in phase 2 to develop the electronic version of Checking In. A bid will be conducted through the NIH to hire a technology development group who will build the Checking In application. This will include the interface development, graphics, and ability for the application to generate a printout summary report. De-identified data from both phase 1 and the physician survey will be utilized to guide the application development.

During phase 3, the electronic version of Checking In will be pilot tested and assessed for feasibility. Sixty quartets, including the patient, parent/caregiver, health care provider and associated staff member will be interviewed for this phase. Patients and their parent/caregiver will be given a tablet and asked to complete Checking In. They will then be asked to complete questionnaires assessing the feasibility of the interface of the Checking In application as well as it s content. A researcher who is present to ensure that the application runs smoothly and that the interface is feasible will also complete a feasibility questionnaire evaluating the interface. Health care providers will be given the associated summary reports and asked to complete a questionnaire assessing the report content and layout as well as impact on patient care.

Once the electronic version of Checking In is finalized, researchers will begin phase 4 of the study. During phase 4, each patient will complete a brief electronic self-report distress scale, Checking In, and standardized measures of depression, anxiety, pain, fatigue, sleep disturbance, and peer relationships, as well as an evidence-based questionnaire for self-harm.

Primary caregivers will rate their child s level of distress using Checking In, as well as complete measures assessing their child s depression, anxiety, pain, fatigue, sleep disturbance, suicide risk and peer relationships

Both patients and primary caregivers will assess the feasibility of completing Checking In. Medical providers will rate the usefulness of the Checking In summary report, as well as provide a performance rating of the patient using Lansky/Karnofsky Performance status scores. Additionally, data collectors will assess the feasibility of administering Checking In in a pediatric outpatient clinic.

-Outcome Measures

Measures include Checking In; Phase 3 Feasibility Questionnaires, Phase 4 PROMIS measures of Anxiety, Depression, Fatigue, Pain Intensity, Pain Interference, Sleep Disturbance, Self Harm (evidence-based questionnaire) and Peer Relationships; and an Feasibility scale for completion of Checking In. Self- harm and suicide risk questions will only be asked to patients 10 and older.

Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress

Positive score on depression, anxiety, pain and fatigue measures

National Institute of Mental Health (NIMH)

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Syndrome

Immunologic Deficiency Syndromes

Neurofibromatosis

Neurofibromatosis Type 1

Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indicate the causes and levels of distress they feel. However, little work has been done on how to assess distress in pediatric patients. This study will investigate the effectiveness of the Distress Thermometer as a tool to accurately measure distress in pediatric patients, and determine whether primary caregivers and physicians can also use the Distress Thermometer to accurately gauge a patient s levels and sources of distress. The study will also investigate the effectiveness of the Distress Thermometer compared with other means of measuring fatigue, mood, and pain levels.

This study will include approximately 90 patients between 7 and 21 years of age who are currently enrolled in a National Institutes of Health pediatric research study. It will also include responses from the primary caregivers and primary medical providers of the patients involved in the study.

All patients will complete the Distress Thermometer s self-reported distress scale and other standardized measures of anxiety, depression, fatigue, and pain. In addition, patients between 18 and 21 years of age will be asked to assess the benefits and negative effects of participating in psychosocial research.

On the same day, the patient s primary caregiver and primary medical provider will complete a Distress Thermometer survey to estimate the patient s distress level. If either the patient or the primary caregiver indicate high levels of distress or mood symptoms, the researchers will offer them an opportunity to speak with a mental health professional. The primary medical provider will also receive a copy of the responses reported on the patient s Distress Thermometer.

OBJECTIVE:

The purpose of this protocol is to evaluate a measure that would assist clinicians in assessing the presence of psychological distress in children and adolescents with serious medical illnesses.

Aim 1: To assess the inter-rater reliability of the Distress Thermometer by comparing ratings of the patient s distress given by the patient, the primary caregiver and the patient s primary medical provider.

Aim 2: To assess the concurrent validity (i.e. the extent to which a test correlates with other previously validated measures of similar constructs) of the Distress Thermometer, a brief screening tool for psychological distress, as compared to validated measures of psychological symptoms (i.e. depression, anxiety, pain and fatigue) in patients with pediatric cancer, Neurofibromatosis Type 1 (NF1) HIV-1 infection, Primary Immune Deficiencies (PIDs), DNA repair diseases, sickle cell disease, and Li-Fraumeni.

Aim 3: To assess the acceptability of completing the Distress Thermometer to patients, primary caregivers, and medical providers.

Aim 4: To assess the feasibility of administering the Distress Thermometer to patients with cancer, NF1, and HIV-1 infection, PIDs, and DNA repair diseases.

Secondary Aim 1: To assess the relationship between the caregiver s self-report of psychological symptoms and his or her rating of the patient s level of distress on the Distress Thermometer.

Secondary Aim 2: To assess whether patient ratings on the Distress Thermometer differ between the specific diseases, controlling for disease severity.

Secondary Aim 3: To assess the burden and benefits of participating in psychosocial research.

STUDY POPULATION:

This study is taking place at the National Institutes of Health (NIH) and Medstar Georgetown University Hospital. All outpatients, ages 7-21, enrolled in a research study either at the Pediatric Clinic, the Primary Immune Deficiency Clinic, or the Dermatology Clinic at the NIH with a diagnosis of pediatric cancer, NF-1, HIV, PIDs, and DNA repair, and those at risk for Li-Fraumeni (P53 positive)syndrome diseases will be invited to participate in this study. Additionally, all outpatients, ages 7-21, seen at Medstar Georgetown University Hospital for HIV or sickle cell disease will be invited to participate in this study.

DESIGN:

Each patient will complete a brief self-report distress scale (the Distress Thermometer) and standardized measures of depression, anxiety, pain, and fatigue. Additionally, all patients will be asked to assess the benefits and burdens of participating in psychosocial research.

Primary caregivers will rate their child s level of distress (using the Distress Thermometer), pain, fatigue anxiety and depression, and complete a self-report measure assessing their own psychological symptoms in addition to questions that assess the benefits and burdens of participating in psychosocial research.

The primary medical provider (physicians or nurse practitioners) will give their estimation of the patient s distress (using the Distress Thermometer).

All patients, primary caregivers and medical providers will assess the acceptability of completing the Distress Thermometer. Additionally, data collectors will assess the feasibility of administering the Distress Thermometer in a pediatric clinic. \<TAB\>

MEASURES:

Measures include the Distress Thermometer, a brief screening tool consisting of a single item rating of distress and a list of possible reasons for distress; the Children s Depression Inventory (CDI); the Brief Symptom Inventory 18 (BSI-18); the State Trait Anxiety Inventory (STAI); the Wong-Baker FACES Pain Scale; the Children s Fatigue Scales; an Acceptability and Feasibility scale for completion of the Distress Thermometer; and two questions regarding perception of research participation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accessible Cancer Care to Enable Support for Survivors Programme	NCT04014309	Survivorship Breast Cancer Gynecologic Can...	Supportive and ... Usual care	21 Years -	National University of Singapore
Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress	NCT02423031	Cancer		8 Years - 21 Years	National Institutes of Health Clinical Center (CC)
The Use of a Distress Thermometer in a Pediatric Research Setting: An Exploratory Pilot Study	NCT00824278	Cancer HIV Infections		7 Years - 21 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for distress screening