Clinical trial NCT06470230: RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
Official title: RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stigma
Keywords: Cancer Related Stigma
Pediatric Cancer Population
Parent/Caregivers
Patients/Survivors
Diverse global settings
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-24
Enrollment: 1320
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active cancer patients or survivors of cancer and adult parents or caregivers of active cancer patients or survivors of cancer.

Brief summary: Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools to identify and measure stigma in the pediatric cancer population within culturally diverse global settings of the United States, Guatemala, and Jordan.

Primary Objectives

* Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
* Pilot new stigma tools in geographically and culturally diverse cancer referral settings in the United States, Guatemala, and Jordan.

Detailed description: There are 2 parts to this study; participants will be included in either Part 1 or Part 2, but not both.

In Part 1 of the study, investigators will conduct a systematic literature review of tools measuring stigma in healthcare at the level of the patient and survivor, or caregiver, through which they will catalog all items included in existing instruments of the study. Literature will be searched for concepts of patient self-stigma and scales, instruments, measurements, or outcomes.

Once the search strategy is completed, a panel of experts will review items and domains sorts to remove confusing or duplicative items and produce final pilot tools containing patient-centered and clinically relevant items. Preliminary tools will be translated into Spanish and Arabic. The preliminary English tools will be professionally translated into Spanish and Arabic. Translated tools will be reviewed by international study teams as well as bilingual members of the St. Jude team to account for regional linguistic differences. The Spanish and Arabic tools will be back translated into English to ensure original intent is maintained. Any modifications needed to ensure language consistency across versions will be made in all languages, ensuring parallel versions of the tool are developed.

We will recruit up to 20 active patients and/or survivor participants aged 8-17.9 in each language (up to 60 total patient/survivor participants), and similar numbers of parents or caregivers (not recruited as dyads) and ask questions about stigma. Experienced interviewers trained by the St. Jude team will verbally administer the tool followed by probing questions to assess face validity and rate each item on a scale of 1-5 based on accuracy, clarity, and difficulty of content. After 3-4 participants have been interviewed in each language, all three tools will be reassessed with modifications made as necessary. This process will be repeated until no additional modifications are identified through interviews.

In Part 2 of the study, children who have or had cancer and their caregivers will test out the questionnaire that was created during Part 1 of the study. Investigators will recruit 225-600 active patients or survivor participants (75-200 in each language) and 225-600 parents or caregivers (75-200 in each language) to pilot the tools.

Eligibility criteria: Inclusion Criteria:

* Cognitive Debriefing and Pilot Data Collection - Patients/Survivors

  * Age 8 to 17.9 years of age
  * Active cancer patients or survivors of cancer
* Cognitive Debriefing and Pilot Data Collection - Parent/Caregivers

  * Adult parents or caregivers (≥ 18 years of age) of active cancer patients or survivors of cancer.

Exclusion Criteria: NA

Primary outcomes:
measure: Develop two clinical tools that can be used to identify and measure stigma as experienced by (1) pediatric oncology patients/survivors and (2) their guardians/caregivers in culturally diverse global settings.
timeFrame: Up to 2 months after the start of study
measure: Pilot new stigma tools in geographically and culturally diverse cancer referral settings.
timeFrame: Approximately one year after the start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Guatemala City
country: Guatemala
facility: UNOP Unidad Nacional De Oncologia Pediatrica
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Dylan Graetz, MD
role: PRINCIPAL_INVESTIGATOR
References: