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Spots Global Cancer Trial Database for Home Away From Home - Quality of Life Surveys

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Trial Identification

Brief Title: Home Away From Home - Quality of Life Surveys

Official Title: Home or Away From Home: Comparing Patient and Caregiver Reported Quality of Life (QoL) and Other Patient-centered Outcomes for Inpatient Versus Outpatient Management of Neutropenia in Children With AML

Study ID: NCT02777021

Interventions

Study Description

Brief Summary: Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. Further, no studies have been conducted that assess the impact of neutropenia management strategy on the quality of life of pediatric patients with AML and their caregivers.

Detailed Description: This is a prospective observational cohort study, where the primary objective of this study is to compare patient and caregiver quality of life and other patient-centered outcomes for inpatient versus outpatient management of neutropenia in children with AML or MDS receiving standard intensive AML frontline chemotherapy. Local study investigators (pediatric oncologists and study coordinators) at each of the fifteen participating pediatric institutions will communicate on a weekly basis with their inpatient leukemia service to identify AML or MDS patients potentially eligible for study enrollment. Once identified, study personnel will review each patient for study eligibility criteria. Three visits with the patient and their caregivers will occur: a screening visit, initial survey visit, and a follow-up visit. Screening Visit: The eligibility criteria for participation will be confirmed prior to approaching for consent. Eligible patients interested in the study will be approached for consent at any time from AML/MDS diagnosis through last day of chemotherapy in the treatment course under study. In some cases, the patient's caregivers may not be present in the hospital to provide consent. In these cases, study personnel will obtain verbal consent from the caregivers and child assent (if appropriate). Visit 1 will occur prior to the last day of chemotherapy administration in the course. This visit will include: * 2 Brief demographic surveys to capture covariates unavailable in the medical record * Baseline health-related quality of life (HRQOL) surveys * A baseline financial toxicity assessment Surveys will be administered via paper or a smart device and will last a total of 15-30 minutes per respondent. In the case that the child is 5 years of age or older, the child self-report and parent proxy-report scales will be separately administered to the child and caregiver, respectively. If the child is under 5 years of age, only the parent-proxy version will be administered. Only the caregiver completes the baseline financial toxicity assessment. We will provide a $25 gift card to each child-parent dyad upon completion of the baseline surveys Visit 2 will occur within the period after absolute neutrophil count recovery and ideally prior to the start of the subsequent course of chemotherapy, but no later than the last day of chemotherapy in that next treatment course. This visit will include: * Follow-up HRQOL surveys * Patient-centered outcome survey developed previously from qualitative interviews of AML patients and their caregivers * A follow-up financial toxicity assessment Surveys will be administered via paper or a smart device and will last a total of 15-30 minutes per respondent. In the case that the child is 5 years of age or older, the child self-report and parent proxy-report scales will be administered to the child and caregiver, respectively. If the child is under 5 years of age, only the parent-proxy version will be administered. The follow-up financial toxicity assessment and the patient-centered outcome survey are completed by the caregiver only. We will provide a $25 gift card to each child-parent dyad upon completion of the follow-up surveys.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Lucile Packard Children's Hospital, Palo Alto, California, United States

Children's Hospital of Colorado, Aurora, Colorado, United States

Nemours/Alfred I DuPont Hospital for Children, Wilmington, Delaware, United States

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

Dana-Farber Cancer Institute/Boston Children's Hospital, Boston, Massachusetts, United States

C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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

Children's Medical Center of Dallas, Dallas, Texas, United States

Texas Children's Hospital, Houston, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

Seattle Children's Hospital, Seattle, Washington, United States

Contact Details

Name: Richard Aplenc, MD, PhD

Affiliation: Children's Hospital of Philadelphia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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