Solid TumorNCT02199548
The Good Patient Study
An observational study of Solid Tumor and Hematological Malignancies, run by St. Jude Children's Research Hospital at 2 sites in United States.
Trial summary
Adolescents with cancer weigh multiple influences in medical decision-making, including their own best interest, the perceived wishes of family members, and the interpreted preferences of the health care team. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Solid Tumor, Hematological Malignancies, Brain Tumor
- What is being tested?
- Interview
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to May 2015
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be teens who are patients at St. Jude Children's Research Hospital and meet the criteria for study enrollment.
Who may be able to join
- Participants must be between 12 and 19 years of age at the time of enrollment.
- Participants must have primary care team approval to participate.
- Participants must be English-speaking.
- Participants must carry an oncologic diagnosis.
- Participants must be within four months of initial oncologic diagnosis or within four months of relapse/recurrent disease.
Who cannot join
- This study lacks any exclusion related to pregnancy (an Institutional Review Board requirement for enrollment of females who are capable of becoming pregnant), lactation or plans to become pregnant and lacks any exclusion of males fathering children while on study.
- Patients who, in the opinion of their physician, are not capable mentally or verbally of participating in the interview, will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Adolescents with cancer weigh multiple influences in medical decision-making, including their own best interest, the perceived wishes of family members, and the interpreted preferences of the health care team. Parents of children with cancer often describe themselves as trying to be a good parent in making decisions in the child's best interest. Adolescents with cancer often describe themselves as trying to be a good patient and good child in making decisions in accord with how they believe a good patient and good child would decide.
Among the challenges of caring for adolescents is the reality that the formative relational influences in adolescents' decision-making are both complex and unique due to adolescent patients' social networks and relational roles. Delineating adolescents' definitions of being a good patient, a good child, a good sibling, and a good friend may enable the care team to better understand the formative decisional influences relevant to adolescents with cancer. Expanding knowledge about the decision making constructs relevant to adolescents with cancer and recognizing the role of these social constructs in medical interactions has the potential for development of a comprehensive care model that methodically evaluates the self-assessed decision making influences and needs of adolescents at various stages in oncology care.
This qualitative construct-defining study represents an initial step in the development of enhanced interventions for improved psychosocial support in this vulnerable population.
Read the detailed description
PRIMARY OBJECTIVES:
- Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions;
- By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making;
- Identify adolescent participants' preferred role in medical decision making.
SECONDARY OBJECTIVES:
- Develop definitions of being a "good" patient, child, sibling, and friend from adolescent participant reports (will also welcome the study participant to self-declare any additional relational constructs they may wish to report);
- Describe how the adolescent study participant believes his or her "good" patient, child, sibling, and friend definition may have changed over time;
- Describe the self-assessed positive and negative aspects of trying to achieve the meanings of the "good" patient, child, sibling, and friend constructs from adolescent participant reports;
- Describe the actions of members of the study participant's social network which may help the study participant reach his/her definition of being a "good" patient, child, sibling, and friend.
Participants will participate in a one-time voice-recorded, face-to-face interview consisting of open-ended questions. Completion of the interview is expected to take less than one hour.
The qualitative interview consists of thirty open-ended questions for participants with no siblings and thirty-eight open-ended questions for participants who have siblings. Questions will be audio-recorded, face-to-face semi-structured in-depth interview format. Health information will also be collected from medical records.
Expected accrual is 100 participants, 50 at each participating site. Accrual will be halted when the study reaches qualitative theme saturation. For this study, saturation will occur when three consecutive interviews fail to raise a new theme.
- Conditions
- Solid Tumor, Hematological Malignancies, Brain Tumor
- Being tested
- Interview
- Keywords
- Adolescent, Decision-making, Social network
- Medical subject headings
- Hematologic Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
This study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | All enrolled participants will take part in a face-to-face interview. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors contributing to decision-making
Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions.
Measured: Once, at enrollment
Behaviors that make a positive impact on decision-making
By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making.
Measured: Once, at enrollment
Preferred decision-making role
Identify adolescent participants' preferred role in medical decision making.
Measured: Once, at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meaghann Weaver, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199548
- Sponsor's protocol ID
- GPS14
- Status last verified
- Jun 2015
- First submitted
- 22 Jul 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Good Patient Study
- ClinicalTrials.gov ID
- NCT02199548
- Acronym / sponsor ID
- GPS14
- Conditions
- Solid Tumor, Hematological Malignancies, Brain Tumor
- Keywords
- Adolescent, Decision-making, Social network
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jul 2014 (estimated)
- 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.
Adolescents with cancer weigh multiple influences in medical decision-making, including their own best interest, the perceived wishes of family members, and the interpreted preferences of the health care team. Parents of children with cancer often describe themselves as trying to be a good parent in making decisions in the child's best interest. Adolescents with cancer often describe themselves as trying to be a good patient and good child in making decisions in accord with how they believe a good patient and good child would decide.
Among the challenges of caring for adolescents is the reality that the formative relational influences in adolescents' decision-making are both complex and unique due to adolescent patients' social networks and relational roles. Delineating adolescents' definitions of being a good patient, a good child, a good sibling, and a good friend may enable the care team to better understand the formative decisional influences relevant to adolescents with cancer. Expanding knowledge about the decision making constructs relevant to adolescents with cancer and recognizing the role of these social constructs in medical interactions has the potential for development of a comprehensive care model that methodically evaluates the self-assessed decision making influences and needs of adolescents at various stages in oncology care.
This qualitative construct-defining study represents an initial step in the development of enhanced interventions for improved psychosocial support in this vulnerable population.
Detailed description
PRIMARY OBJECTIVES:
- Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions;
- By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making;
- Identify adolescent participants' preferred role in medical decision making.
SECONDARY OBJECTIVES:
- Develop definitions of being a "good" patient, child, sibling, and friend from adolescent participant reports (will also welcome the study participant to self-declare any additional relational constructs they may wish to report);
- Describe how the adolescent study participant believes his or her "good" patient, child, sibling, and friend definition may have changed over time;
- Describe the self-assessed positive and negative aspects of trying to achieve the meanings of the "good" patient, child, sibling, and friend constructs from adolescent participant reports;
- Describe the actions of members of the study participant's social network which may help the study participant reach his/her definition of being a "good" patient, child, sibling, and friend.
Participants will participate in a one-time voice-recorded, face-to-face interview consisting of open-ended questions. Completion of the interview is expected to take less than one hour.
The qualitative interview consists of thirty open-ended questions for participants with no siblings and thirty-eight open-ended questions for participants who have siblings. Questions will be audio-recorded, face-to-face semi-structured in-depth interview format. Health information will also be collected from medical records.
Expected accrual is 100 participants, 50 at each participating site. Accrual will be halted when the study reaches qualitative theme saturation. For this study, saturation will occur when three consecutive interviews fail to raise a new theme.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Other: InterviewAll enrolled participants will take part in a face-to-face interview. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be teens who are patients at St. Jude Children's Research Hospital and meet the criteria for study enrollment.
Key inclusion criteria (5 listed)
- Participants must be between 12 and 19 years of age at the time of enrollment.
- Participants must have primary care team approval to participate.
- Participants must be English-speaking.
- Participants must carry an oncologic diagnosis.
- Participants must be within four months of initial oncologic diagnosis or within four months of relapse/recurrent disease.
Key exclusion criteria (2 listed)
- This study lacks any exclusion related to pregnancy (an Institutional Review Board requirement for enrollment of females who are capable of becoming pregnant), lactation or plans to become pregnant and lacks any exclusion of males fathering children while on study.
- Patients who, in the opinion of their physician, are not capable mentally or verbally of participating in the interview, will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewThis study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions. | Other | Study Participants |
Primary outcome
Factors contributing to decision-making
Time frame: Once, at enrollment
Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions.
Behaviors that make a positive impact on decision-making
Time frame: Once, at enrollment
By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making.
Preferred decision-making role
Time frame: Once, at enrollment
Identify adolescent participants' preferred role in medical decision making.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- 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.
Meaghann Weaver, MD 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 Solid Tumor and Hematological Malignancies, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jun 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Factors contributing to decision-making (time frame: Once, at enrollment). The study lists 3 primary outcomes in all. 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 4 Jun 2015.