CancerDIARY1NCT01477255
The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population
An observational study of Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This investigation seeks to determine the feasibility of an electronic diary methodology among pediatric cancer patients and healthy matched controls. Levels of study participation and compliance will be assessed to assist with determining overall feasibility. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- iPad
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2016
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All eligible participants will be invited to participate in the research investigation, including children and parents of both genders and of all races/ethnicities. St. Jude treats pediatric patients from across the country and around the world, which results in a culturally diverse pediatric population. Based upon enrollment patterns from previous investigations, it is anticipated that approximately 19% of enrolled pediatric participants will be racial/ethnic minority children. Because the control group will be matched to the pediatric group on variables of gender, age, race/ethnicity, and socioeconomic status, it is anticipated that the gender and race/ethnicity of the control group will be commensurate with that of the pediatric group.
Who may be able to join
- Research participant is between ages 8 and 17 years inclusive.
- Research participant has received a diagnosis of malignancy in the period 10 weeks prior to enrollment.
- Research participant has no significant cognitive, motor, or sensory deficits that would preclude completion of the study measures.
- Research participant is able to speak and read English.
- Research participant is between ages 8 and 17 years inclusive.
- Research participant has no history of a major medical diagnosis.
- Research participant has no significant cognitive, motor, or sensory deficits that would preclude completion of the study measures.
- Research participant is able to speak and read English.
Who cannot join
- Participants are excluded if they fail to meet any of the Inclusion Criteria for Pediatric or Control Participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population: A Pilot Study
This investigation seeks to determine the feasibility of an electronic diary methodology among pediatric cancer patients and healthy matched controls. Levels of study participation and compliance will be assessed to assist with determining overall feasibility. Results will offer insight into the effectiveness of this means of data collection with a pediatric oncology population, and will examine how psychosocial and contextual factors contribute to the resiliency that has been demonstrated by children with cancer. Findings will provide data for the design and implementation of a future, larger-scale study with this pediatric population that implements an electronic daily diary methodology.
Read the detailed description
The study will include two phases of participant recruitment and participation. Phase I will include recruitment of six pediatric patients to pilot an electronic daily diary on an Apple iPad. These participants will be prompted by the iPad once daily for seven days, and will be asked to answer multiple choice and yes/no questions related to their daily experiences, activities and emotions. Following the week of daily diary completion, each participant in Phase I will engage in a brief feedback interview with a member of the research team to discuss his/her overall experiences using the electronic diary, including any technological issues that arise. The purpose of Phase I is to work out any technological and/or logistical problems associated with completion of the daily iPad diary.
After any technological problems have been addressed, Phase II of the study will begin. Child participants in Phase II of the study will complete several paper and pencil questionnaires on two separate occasions that assess factors including optimism, experience of various emotions, spirituality, relationships with others, benefit-finding, quality of life, and resiliency. Children will also complete two weeks of daily electronic diaries that will prompt them to answer multiple choice and yes/no questions related to their daily experiences, activities and emotions. One parent or guardian will also be recruited to participate, and will complete paper and pencil questionnaires on two separate occasions that ask about optimism, the parent-child relationship, spirituality, psychological functioning, and their perceptions of their children's behavior and mood.
Finally, following the completion of the first week of daily diaries, a short interview will be conducted with each child and parent dyad to gather information about the child's experiences using the electronic diary. They will be asked to provide feedback about any challenges and technological difficulties that they encountered, as well as their general thoughts about using the electronic diary. The interview will also include an opportunity to trouble-shoot difficulties associated with using the electronic daily diary in preparation for the second week of diary completion. For each participant, we anticipate a participation timeframe of 10-15 weeks.
Primary Objective:
- To evaluate the usefulness of an electronic daily diary for understanding the experiences, emotions, and coping strategies of children with cancer and of their healthy peers.
- Conditions
- Cancer
- Being tested
- iPad
- Keywords
- daily assessment, electronic diary, coping strategies, resiliency of cancer patients, psychology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPadBehavioural
Also called electronic diary
The proposed investigation is a prospective case-control pilot study. The major goal of this pilot study is to assess the feasibility of a daily diary methodology for monitoring the experiences of recently diagnosed pediatric cancer patients and healthy-matched peers. The investigation will also examine the relationships among individual and contextual factors that influence the daily psychosocial functioning of youth with cancer in comparison to youth without cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patient | Patient participants will include children and adolescents between the ages of 8-17 years who have been recently diagnosed with cancer. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences. Receives: Behavioral: iPad | |
| Control | For each pediatric patient enrolled, a child without a history of a serious medical illness will be recruited from the larger community who is matched on variables of age, race/ethnicity, gender, and socioeconomic status. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences. Receives: Behavioral: iPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number who agree to participate compared to the total number approached for the study.
The rate of agreement to participate in the study.
Measured: Day 0 of study
The number of total days the participant was able to complete the daily diary.
The rate of completion of daily diary measures, and the number of participants who complete the study in its entirety.
Measured: From on-study date through up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Phipps, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477255
- Sponsor's protocol ID
- DIARY1
- Acronym
- DIARY1
- Status last verified
- Apr 2016
- First submitted
- 15 Nov 2011
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population: A Pilot Study
- ClinicalTrials.gov ID
- NCT01477255
- Acronym / sponsor ID
- DIARY1 / DIARY1
- Conditions
- Cancer
- Keywords
- daily assessment, electronic diary, coping strategies, resiliency of cancer patients, psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Nov 2011 (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.
This investigation seeks to determine the feasibility of an electronic diary methodology among pediatric cancer patients and healthy matched controls. Levels of study participation and compliance will be assessed to assist with determining overall feasibility. Results will offer insight into the effectiveness of this means of data collection with a pediatric oncology population, and will examine how psychosocial and contextual factors contribute to the resiliency that has been demonstrated by children with cancer. Findings will provide data for the design and implementation of a future, larger-scale study with this pediatric population that implements an electronic daily diary methodology.
Detailed description
The study will include two phases of participant recruitment and participation. Phase I will include recruitment of six pediatric patients to pilot an electronic daily diary on an Apple iPad. These participants will be prompted by the iPad once daily for seven days, and will be asked to answer multiple choice and yes/no questions related to their daily experiences, activities and emotions. Following the week of daily diary completion, each participant in Phase I will engage in a brief feedback interview with a member of the research team to discuss his/her overall experiences using the electronic diary, including any technological issues that arise. The purpose of Phase I is to work out any technological and/or logistical problems associated with completion of the daily iPad diary.
After any technological problems have been addressed, Phase II of the study will begin. Child participants in Phase II of the study will complete several paper and pencil questionnaires on two separate occasions that assess factors including optimism, experience of various emotions, spirituality, relationships with others, benefit-finding, quality of life, and resiliency. Children will also complete two weeks of daily electronic diaries that will prompt them to answer multiple choice and yes/no questions related to their daily experiences, activities and emotions. One parent or guardian will also be recruited to participate, and will complete paper and pencil questionnaires on two separate occasions that ask about optimism, the parent-child relationship, spirituality, psychological functioning, and their perceptions of their children's behavior and mood.
Finally, following the completion of the first week of daily diaries, a short interview will be conducted with each child and parent dyad to gather information about the child's experiences using the electronic diary. They will be asked to provide feedback about any challenges and technological difficulties that they encountered, as well as their general thoughts about using the electronic diary. The interview will also include an opportunity to trouble-shoot difficulties associated with using the electronic daily diary in preparation for the second week of diary completion. For each participant, we anticipate a participation timeframe of 10-15 weeks.
Primary Objective:
- To evaluate the usefulness of an electronic daily diary for understanding the experiences, emotions, and coping strategies of children with cancer and of their healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patient | – | Behavioral: iPadPatient participants will include children and adolescents between the ages of 8-17 years who have been recently diagnosed with cancer. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences. |
| Control | – | Behavioral: iPadFor each pediatric patient enrolled, a child without a history of a serious medical illness will be recruited from the larger community who is matched on variables of age, race/ethnicity, gender, and socioeconomic status. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All eligible participants will be invited to participate in the research investigation, including children and parents of both genders and of all races/ethnicities. St. Jude treats pediatric patients from across the country and around the world, which results in a culturally diverse pediatric population. Based upon enrollment patterns from previous investigations, it is anticipated that approximately 19% of enrolled pediatric participants will be racial/ethnic minority children. Because the control group will be matched to the pediatric group on variables of gender, age, race/ethnicity, and socioeconomic status, it is anticipated that the gender and race/ethnicity of the control group will be commensurate with that of the pediatric group.
Key inclusion criteria (8 listed)
- Research participant is between ages 8 and 17 years inclusive.
- Research participant has received a diagnosis of malignancy in the period 10 weeks prior to enrollment.
- Research participant has no significant cognitive, motor, or sensory deficits that would preclude completion of the study measures.
- Research participant is able to speak and read English.
- Research participant is between ages 8 and 17 years inclusive.
Key exclusion criteria (1 listed)
- Participants are excluded if they fail to meet any of the Inclusion Criteria for Pediatric or Control Participants.
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 |
|---|---|---|
| iPadAlso: electronic diaryThe proposed investigation is a prospective case-control pilot study. The major goal of this pilot study is to assess the feasibility of a daily diary methodology for monitoring the experiences of recently diagnosed pediatric cancer patients and healthy-matched peers. The investigation will also examine the relationships among individual and contextual factors that influence the daily psychosocial functioning of youth with cancer in comparison to youth without cancer. | Behavioural | Cancer patient, Control |
Primary outcome
The number who agree to participate compared to the total number approached for the study.
Time frame: Day 0 of study
The rate of agreement to participate in the study.
The number of total days the participant was able to complete the daily diary.
Time frame: From on-study date through up to 4 months
The rate of completion of daily diary measures, and the number of participants who complete the study in its entirety.
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 8 Apr 2016.
- 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.
Sean Phipps, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by St. Jude Children's Research Hospital at 1 site 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 8 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: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The number who agree to participate compared to the total number approached for the study. (time frame: Day 0 of study). The study lists 2 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 8 Apr 2016.