Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring Health Related Quality of Life in AYAs (PROMIS AYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482778
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease
Oncology Quality of Life PROM

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: PROMIS AYA AIM1A
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2022

Group/Cohort
AYA Patients
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.
AYA Providers
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.
Content Experts
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.



Primary Outcome Measures :
  1. Number and type of themes for financial burden [ Time Frame: baseline ]
    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.

  2. Number and type of themes for body image [ Time Frame: baseline ]
    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.

  3. Number and type of themes for fertility and future parenthood [ Time Frame: baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents or young adults diagnosed with cancer (except for basal cell skin cancer) at 15 to 39 years of age. Patients who have met with a reproductive specialist or who have indicated a pre-treatment desire to have biological children will be prioritized in recruitment.
Criteria

Inclusion Criteria:

  • 15 to 39 years of age
  • diagnosed with cancer at 15 to 39 years of age
  • able to read and understand English
  • have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 5 years post-treatment

Exclusion Criteria:

  • diagnosed with basal cell skin cancer
  • experienced a cancer recurrence
  • currently receiving palliative or hospice care
  • had an infertility diagnosis prior to their cancer diagnosis
  • report a significant psychiatric history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482778


Contacts
Layout table for location contacts
Contact: John M Salsman, Ph.D. 336-713-3613 jsalsman@wakehealth.edu
Contact: Denisha Little-Greene 336-713-5061 drlittle@wakehealth.edu

Locations
Layout table for location information
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: David E Victorson, Ph.D.    847-467-3060    d-victorson@northwestern.edu   
United States, North Carolina
Brenner Children's Hospital Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: John M Salsman, Ph.D.    336-713-3613    jsalsman@wakehealth.edu   
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: John M Salsman, PhD    336-713-3613    jsalsman@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Feinberg School of Medicine, Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: John M Salsman, Ph.D. Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03482778    
Other Study ID Numbers: IRB00044525
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
PROMIS
AYA
ONCOLOGY
HRQOL
Adolescent and Young Adult
Health Related Quality of Life Measurement
Patient-Reported Outcomes Measurement Information System
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms