Behaviors and Mental Disorders

All Conditions

Quality of Life

Qualitative data collection will occur through one-on-one semi-structured interviews with AYA patients (n=36). AYA patients are eligible if they: (1) are 15 to 39 years of age, (2) were diagnosed with cancer at 15 to 39 years of age; (3) are able to read and understand English; (4) have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 5 years post-treatment. AYA patients will be excluded if they: (1) were diagnosed with basal cell skin cancer; (2) experienced a cancer recurrence; (3) are currently receiving palliative or hospice care; (4) had an infertility diagnosis prior to their cancer diagnosis, or (5) report a significant psychiatric history.

Qualitative data collection will occur through one-on-one semi-structured interviews with AYA providers (n=36). Providers will be health professionals who provide supportive care for AYAs to help address financial, body image, and fertility/future parenthood concerns or needs. Psychosocial providers (e.g., social workers, patient navigators, psychologists) will all be eligible to participate. We will also include reproductive endocrinologists, nurse practitioners, and other medical professionals who have expertise in the appropriate area of health-related quality of life (HRQOL). Additional inclusion criteria will be: (1) provision of care to AYAs; (2) ≥2 years practicing; (3) English-speaking.

Qualitative data collection will occur through one-on-one semi-structured interviews with content experts (n=36). Content experts are a purposive sample of scientists and clinicians who have recognized expertise in each of the three domains of interest to this project - financial burden, body image, and fertility/future parenthood.

Five forms have been created for AYA patients (n=25). Each form consists of 25 to 30 items. Forms for AYA patients include an even number of items from the body image, financial burden, and fertility domains counterbalanced in order of administration to reduce the potential for order effects. Participants will also complete a sociodemographic form and, to evaluate literacy and reading grade equivalent, an interviewer-administered Wide Range Achievement Test (WRAT-5) will also be completed. Only the Word Reading portion of the WRAT-5 will be administered to the participants. Cognitive interviews will be conducted over 2 rounds with half the sample comprising each round. Items substantially revised from Round 1 will be re-evaluated in Round 2.

Two forms for AYA caregivers (n=10). Each form consists of 25 to 30 items. Forms for AYA caregivers only include items from the financial burden domain. Participants will also complete a sociodemographic form and, to evaluate literacy and reading grade equivalent, an interviewer-administered Wide Range Achievement Test (WRAT-5) will also be completed. Only the Word Reading portion of the WRAT-5 will be administered to the participants. Cognitive interviews will be conducted over 2 rounds with half the sample comprising each round. Items substantially revised from Round 1 will be re-evaluated in Round 2.

John M Salsman, Ph.D.

Regina Smith, BS, CCRP

David E Victorson, Ph.D.

John M Salsman, PhD

AIM1a:

AYAs with cancer experience many challenges that impact their health-related quality of life (HRQOL) but few measures adequately capture AYAs' HRQOL in valid and reliable ways. The main goal of the study is to expand the use of the Patient-Reported Outcome Measurement Information System (PROMIS) to provide valid and reliable assessment of important HRQOL concerns for AYAs. The study team will do this by validating existing PROMIS measures and developing and validating new measures of financial distress, fertility/parenthood concerns, and body image concerns for AYAs with cancer.

AIM1b:

Investigators have developed conceptual frameworks and created item pools for body image, fertility, and financial burden domains and are ready to proceed with the next aim of our measure development work, cognitive interview testing.

AIM1a:

There are approximately 70,000 new diagnoses of cancer annually in adolescents and young adults (AYAs; ages 15-39), and nearly 2 million people in the United States are living with or have survived being diagnosed with cancer as an AYA. Despite the high number of AYA survivors, survival rates of AYAs have not kept pace with those of their younger or older counterparts. AYAs face unique challenges given the physical, cognitive, and psychosocial developmental milestones that may be disrupted as a result of their cancer experience. In addition to the age-related disparities in survival rates, AYAs are at greater risk of significant psychological and financial distress compared to older adults with cancer. Accordingly, assessing and better understanding the unique needs and health-related quality of life (HRQOL) of this important, underserved group as they manage their cancer experience is essential in order to optimize and tailor supportive care approaches.

A few HRQOL conceptual frameworks exist that describe the types of symptom burden and functional impact experienced by AYAs with cancer, but most HRQOL measures fail to capture the range of HRQOL domains that are important to AYAs. Further, measures of HRQOL specifically developed for AYAs lack common items and standardized scoring approaches across the age range of 15-39, limiting the ability to understand the unique needs of this age group. The NIH's Patient-Reported Outcomes Measurement Information System (PROMIS) assesses most of the relevant HRQOL domains (pain, fatigue, anxiety, depression, cognitive functioning, physical functioning, sexual functioning, and social support) but has not been validated in AYAs and PROMIS does not include key domains such as financial distress, body image concerns, or fertility/ parenthood concerns that provide a complete perspective of HRQOL in AYAs with cancer.

The main objective of the study is to expand the use of PROMIS to provide reliable and valid assessment of important HRQOL concerns for AYAs. To accomplish this goal, the study team propose the following specific aims: (1) develop item pools of financial distress, body image concerns, and fertility/parenthood concerns for AYAs with cancer using PROMIS measurement development methodologies; (2) calibrate item banks and short forms of financial distress, body image concerns, and fertility/ parenthood concerns in a large, developmentally diverse sample of AYAs with and without cancer; and (3) validate newly developed short forms of financial distress, body image concerns, and fertility/ parenthood concerns along with existing PROMIS short forms in a developmentally and clinically diverse, prospective sample of AYAs with cancer.

At the end of this research study, the investigators will have a psychometrically robust, state-of-the-art measurement system tailored to AYAs' unique HRQOL needs. Through the identification, adaptation, and development of reliable, valid, and responsive measures of HRQOL for AYAs with cancer, the investigators will give these underserved patients a voice and provide the assessment tools clinicians and researchers need to enhance patient-centered care.

AIM1b:

In this project, are utilizing the cutting-edge measures and scientific standards of the PROMIS in the development of new item banks for financial burden, body image, and fertility, and in the examination of the psychometric properties of existing PROMIS measures for use in AYAs with cancer. For the purposes of this current protocol, investigators will focus on the cognitive interview stage of this process to evaluate the comprehensibility of the preliminary item pools.

Measuring Health Related Quality of Life in AYAs

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology:

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for financial burden that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for body image that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for fertility and future parenthood that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Investigators will ascertain: (a) comprehension of the question (i.e., what does the respondent believe the question is asking; what do specific words, phrases and concepts in the question mean to the respondent); (b) the processes used by the respondent to retrieve relevant information from memory (i.e., what does the respondent need to recall to be able to answer the question; what strategies does the respondent use to retrieve the information); and (c) response processes (i.e., can the respondent match his/her response to the question's response options). Participant responses to interview questions will be coded 0 or 1 reflecting adequate comprehension or misunderstanding. Translatability review will also be conducted by FACITtrans to identify items/concepts that may not translate easily or prove to have limited or no conceptual equivalence in other cultures and to suggest alternative wording changes.

Northwestern University Feinberg School of Medicine

Wake Forest University Health Sciences

Children, adolescents, and young adults diagnosed with cancer before the age of 40 enrolled at any point during the diagnosis-treatment-survivorship continuum.

Andrew Smitherman, MD

Lauren Lux, MSW

Purpose: This study aims to create a registry of childhood, adolescent, and young adult patients with cancer (\<40 years-old at cancer diagnosis), entitled the 'UNC Childhood, Adolescent, and Young Adult Cancer Cohort' (UNC-CAYACC). This resource will serve to support cancer outcomes research among pediatric and young adult cancer patients with a primary focus on enrolling patients treated as adolescents or young adults (AYAs, 15-39 years).

Procedures: As appropriate for age, participants will complete physical and cognitive functional assessments; questionnaires to assess health-related quality of life and other patient-reported outcomes; will undergo body composition and anthropometric measurements; and will be asked to provide biospecimens for biobanking. Assessments will be collected (as possible) at diagnosis, during active treatment, following treatment completion, and annually in survivorship to assess outcomes throughout the treatment and survivorship trajectory. Sociodemographic and clinical information such as cancer treatment modalities and cumulative doses will be collected by medical record abstraction. Participants will be eligible to enroll at any time from diagnosis through survivorship. This registry will provide data to better understand the manifestations of accelerated aging and key contributing factors among children, adolescents, and young adults with cancer.

Up to 22.5 milliliters of peripheral blood

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

De-identified aggregate data will be available upon request. De-identified or coded individual data from the registry may be made available upon request following completion of necessary data use agreements and with Institutional Review Board (IRB) approval.

Creation of a registry of pediatric and young adult patients with cancer treated within the University of North Carolina Health System

Assess feasibility for completing repeated physical and cognitive functional assessments among young cancer survivors. These assessments include measures of physical and general frailty.

Assess feasibility for collection of sociodemographic (including social determinants of health), cancer (e.g., site and stage), and treatment (e.g., modalities and cumulative doses) variables using patient questionnaires and medical record abstraction.

Assess feasibility for the repeated collection of patient-reported measures of health-related quality of life, health behaviors, and functional status.

Hyundai Hope On Wheels

UNC Lineberger Comprehensive Cancer Center

Subjects will have access to their oncology health care providers and other members of the health care team for questions related to cancer and cancer treatment (as per usual).

Subjects will receive access to DECIDES with an informational handout that includes goals of the decision support intervention and instructions for accessing the application independently.

Subjects will receive access to DECIDES with live, coach-assisted support.

DECIDES is a developmentally appropriate, engaging and interactive web-based decision support application designed to address health literacy through education about cancer and cancer treatment, and provide support for AYA patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.

Decision Aid for Education and Support about Cancer Treatment (DECIDES)

Live support in the form of a coach is provided to support navigation of DECIDES and promote involvement in decision-making. DECIDES is a developmentally appropriate, engaging and interactive web-based decision support application designed to address health literacy through education about cancer and cancer treatment, and provide support for AYA patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.

Decision Aid for Education and Support about Cancer Treatment with Coach-Assisted Support (DECIDES + coach)

Lamia Barakat, PhD

The goals of this clinical trial are to evaluate DECIDES, a web-based decision support application that provides education about cancer and cancer treatment and provides support to encourage adolescent and young adult (AYA) patients, their caregivers, and oncology health care providers to make informed decisions about cancer treatment together.

The main questions this study aims to answer are:

* Is DECIDES acceptable, usable, and feasible for AYA, caregivers, and oncology health care providers?
* Is DECIDES helpful for AYA, caregivers, and oncology health care providers that are making cancer treatment decisions together?

AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups: (1) Usual Care, (2) DECIDES, or (3) DECIDES + Coach. Participants in 'Usual Care' will continue to have access to their oncology health care team for questions related to cancer and cancer treatment, as per usual standard of care. Participants in both 'DECIDES' and 'DECIDES + Coach' groups will receive access to DECIDES, and those in 'DECIDES + Coach' will receive additional live, coach-assisted support. After 8 weeks, AYA and caregivers will complete a follow-up questionnaire and those in the 'DECIDES' and 'DECIDES + Coach' groups will complete a semi-structured qualitative interview. Oncology health care providers of participating AYA will be invited to participate in a questionnaire and semi-structured qualitative interview. Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES (with and without coach-assisted support) report more positive decision-making processes compared to those that receive usual standard of care.

DECIDES is a developmentally appropriate, engaging, and interactive web-based decision support application that has been designed to address health literacy and includes:

* Education on cancer and cancer treatments, including clinical trials
* An exercise to identify perceived barriers and benefits to treatment options
* An exercise to clarify personal goals for treatment that align with life goals
* Resources to support communication with the oncology health care team

Family Units (AYA and caregiver participants) are randomized to one of three arms: (1) Usual Care \[no intervention\], (2) DECIDES \[access to web-based decision aid\], or (3) DECIDES + Coach \[access to web-based decision aid with coach-assisted support\].

Oncology health care providers of participating AYA are not enrolled in an intervention arm.

Decision Aid for Education and Support About Cancer Treatment

This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES + Coach). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability.

This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score \>80.3 reflects letter grade "A" (adjective rating "excellent"); 68-80.3 reflects letter grade "B" (adjective rating "good"), 68 reflects letter grade "C" (adjective rating "OK"); 51-67 reflects letter grade "D" (adjective rating "poor"); and \<51 reflects letter grade "F" (adjective rating "awful").

A semi-structured qualitative interview is conducted with AYA, caregivers, and oncology health care providers to assess the acceptability, feasibility, and usability of DECIDES. Interview data is used to inform implementation strategies for future dissemination.

This is a 25-item true/false questionnaire collected to measure AYA and caregiver knowledge of clinical trials. Items are scored (correct versus incorrect) and an overall knowledge score that ranges from 0-100 is calculated based on % correct.

This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Higher scores reflect more support for participation (range = 6-30), perceived incentives for participation (range = 3-15), trust in participation (range = 11-55), barriers/costs to participation (range = 9-45) and greater decision balance about participation \[range = -3 (negative) - 3 (positive) valence\].

This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret).

This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident).

This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction.

This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician.

The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process.

Children's Hospital of Philadelphia

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Digestive System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Antibodies

Folic Acid

Immunoglobulins

Mirvetuximab soravtansine

Vitamin B Complex

Maytansine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunoconjugates

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Mirvetuximab Soravtansine (MIRV) plus Bevacizumab

Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measuring Health Related Quality of Life in AYAs	NCT03482778	Oncology Quality of Life		15 Years - 39 Years	Wake Forest University Health Sciences
UNC Childhood, Adolescent, and Young Adult Cancer Cohort	NCT05096923	Pediatric Cance... Cancer Cancer Metastat... Survivorship		1 Year - 39 Years	UNC Lineberger Comprehensive Cancer Center
Decision Aid for Education and Support About Cancer Treatment	NCT06191679	Cancer Childhood Cance...	Decision Aid fo... Decision Aid fo...	15 Years - 24 Years	Children's Hospital of Philadelphia
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)	NCT05445778	Ovarian Cancer Peritoneal Canc... Fallopian Tube ...	Mirvetuximab so... Bevacizumab	18 Years -	ImmunoGen, Inc.
Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma	NCT06341712	Osteosarcoma Osteosarcoma in... Osteosarcoma in...	Cabozantinib Best Supportive... Best Supportive...	5 Years - 30 Years	Ipsen
Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients	NCT05336318	Cancer Psychosocial Pr...	Peer support	18 Years - 39 Years	University of Leipzig
Physical Activity for Adolescent and Young Adult Cancer Survivors	NCT03016728	Adolescent and ...	Physical Activi...	15 Years - 44 Years	University of Ottawa
CyberCycling to Reduce Therapeutic Side Effects and Improve Quality of Life in AYA Cancers	NCT02916472	Adolescent and ...	CyberCycling Stretching Resistance Band...	15 Years - 30 Years	Case Comprehensive Cancer Center
UNC Childhood, Adolescent, and Young Adult Cancer Cohort	NCT05096923	Pediatric Cance... Cancer Cancer Metastat... Survivorship		1 Year - 39 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for aya

Every month we try and update this database with for aya cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aya

Every month we try and update this database with for aya cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aya cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.