Quality of LifeNCT05412563
Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients
An observational study of Quality of Life, run by St. Jude Children's Research Hospital at 2 sites in United States.
Trial summary
This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2022to 18 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Those who meet the Inclusion criteria and consent to participate
Who may be able to join
- Caregiver is 18 years of age or older
- Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian
- If more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation
- Caregiver is comfortable speaking and reading English
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Cancer Institute/National Institutes of Health
Bethesda, Maryland, 20892
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.
Primary Objective
- To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.
Read the detailed description
Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.
- Conditions
- Quality of Life
- Keywords
- Palliative Care, Pediatric Oncology Patients, Caregiver, Phase I studies, Associated Distress, Hopes, Worries
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of patient and family experience
Qualitative analysis of interviews done with parents of children with cancer who are enrolling in phase 1 studies will be performed. Broad thematic domains will be identified through a rigorous review of transcript data, with the development of codes to delineate conceptual categories. Domains will be further sub-stratified as text analysis progresses in order to identify new themes and formulate new concepts and theories. To enhance construct validity and reliability of identified domains, data will be audited by an expert panel of PPC investigators with proficiency in communication-based research, including both clinicians and researchers. Coding schemata will remain flexible to accommodate expansion of the list as the PI and expert panel agree on new code additions. Following the well-described processes of disassembling and reassembling coding categories, emerging themes will be categorized and refined, with the ultimate goal of theory-building.
Measured: Up to approximately 8 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Sep 2022
- Primary completion18 Dec 2024
- Study completion18 Feb 2025
Why it stopped: IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Kaye, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412563
- Sponsor's protocol ID
- EPCP1
- Other IDs
- NCI-2022-04886
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT05412563
- Acronym / sponsor ID
- EPCP1
- Conditions
- Quality of Life
- Keywords
- Palliative Care, Pediatric Oncology Patients, Caregiver, Phase I studies, Associated Distress, Hopes, Worries
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.
Primary Objective
- To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.
Detailed description
Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Those who meet the Inclusion criteria and consent to participate
Key inclusion criteria (4 listed)
- Caregiver is 18 years of age or older
- Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian
- If more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation
- Caregiver is comfortable speaking and reading English
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative assessment of patient and family experience
Time frame: Up to approximately 8 months after enrollment
Qualitative analysis of interviews done with parents of children with cancer who are enrolling in phase 1 studies will be performed. Broad thematic domains will be identified through a rigorous review of transcript data, with the development of codes to delineate conceptual categories. Domains will be further sub-stratified as text analysis progresses in order to identify new themes and formulate new concepts and theories. To enhance construct validity and reliability of identified domains, data will be audited by an expert panel of PPC investigators with proficiency in communication-based research, including both clinicians and researchers. Coding schemata will remain flexible to accommodate expansion of the list as the PI and expert panel agree on new code additions. Following the well-described processes of disassembling and reassembling coding categories, emerging themes will be categorized and refined, with the ultimate goal of theory-building.
Results and safety
The study was stopped early (reason given: IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Kaye, MD, MPH principal investigator
St. Jude Children's Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by St. Jude Children's Research Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of patient and family experience (time frame: Up to approximately 8 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.