Measuring Health Related Quality of Life in AYAs

NCT03482778 | Completed

• 2 other identifiers: IRB00044525CCCWFU04617
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Oncology; Quality of Life

Keywords

PROMIS; AYA; ONCOLOGY; HRQOL; Adolescent and Young Adult; Health Related Quality of Life Measurement; Patient-Reported Outcomes Measurement Information System

Outcome Measures

Primary Outcomes (4)

• Number and type of themes for financial burden - Aim1A

  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.

  Baseline

• Number and type of themes for body image - Aim1A

  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.

  Baseline

• Number and type of themes for fertility and future parenthood - Aim1A

  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.

  Baseline

• Number of Participants with Adequate Understanding of Trial Themes Through Cognitive Interviews

  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.

  Baseline

Study Arms (5)

AYA Patients - AIM1A

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 - AIM1A

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 - AIM1A

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.

AYA Patients - AIM1B

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.

AYA Caregivers - AIM1B

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.

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• AYA Caregivers:
• years or age or older.
• Able to read and understand English
• Have a child/ward/partner for whom they are providing care and at least partly financially responsible.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (3)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• John M Salsman, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: February 9, 2018
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (3)