A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment

Completed

• Conditions: Sarcoma
• Interventions: Behavioral: Interview; Behavioral: Observations; Behavioral: Guided Activities

• Registration Number: NCT02041689
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. Little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. This information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment.

This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to change the health outcomes of the participants in this study. The observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.

Detailed Description

This is a longitudinal qualitative case study, and no randomized interventions will be used. Instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting.

PRIMARY OBJECTIVE:

* The primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• The child is between the ages of 7 and 11 years on the day of their initial arrival to the hospital
• The child has a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma that will require multimodal therapy to include chemotherapy, plus or minus surgical resection, plus or minus radiation therapy.
• Both the child and parents speak English as their primary language
• Parents are willing to give consent and child is willing to give assent

Exclusion Criteria

• The child has a pre-existing, documented learning disability or cognitive impairment and has previously received learning accommodations under an individualized education plan (IEP).
• The child has a pre-existing, documented diagnosis of autism spectrum disorder (including autism and Asperger's disorder).
• Child has previously received treatment for a cancer diagnosis either at St. Jude or another institution.
• Parent and/or child are unwilling or unable to give consent/assent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Observations	Patients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma. Interventions: two unstructured life-story interview sessions, observations, and guided activities.
Participants	Interview	Patients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma. Interventions: two unstructured life-story interview sessions, observations, and guided activities.
Participants	Guided Activities	Patients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma. Interventions: two unstructured life-story interview sessions, observations, and guided activities.

Primary Outcome Measures

Name	Time	Method
Case study of the ways in which children with cancer learn about their diagnosis and treatment in the hospital setting	Observations collected from diagnosis through 6 months	Data will be collected during individual interviews, guided activity sessions, and observations of participant clinic appointments, inpatient admissions, and other medical events. Because there are no hypotheses to be tested or evaluated, and because this is a qualitative study, no statistical analyses will be used. Instead, coding and categorizing techniques will be used as are common in multiple case study designs. Data analysis in this study will occur constantly and simultaneously alongside data collection and interpretation. Data sources will be analyzed between and within participants using multiple case study analysis. Contextualizing analysis will be used to construct a thematic analysis.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States