Childhood CancerNCT02559219
Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and Patient Satisfaction
An observational study of Childhood Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and Patient Satisfaction is a pilot project designed to test the feasibility and acceptability of use of an online care plan generator for adult survivors of pediatric cancers. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Questionniares
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 16 Sep 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: any person who has received a cancer diagnosis of acute lymphoblastic leukemia (ALL) or Hodgkins lymphoma (HL) before the age of 21 and now is 15 years or older and is now off therapy (considered in remission).
Who may be able to join
- Patients with a cancer diagnosis of acute lymphoblastic leukemia or Hodgkin's lymphoma
- Diagnosis before age 21 years
- Currently off therapy and considered in remission
- Currently 15 years or older
Who cannot join
- Persons who have never had cancer or who have another pediatric malignancy (Wilms tumor, neuroblastoma) as the website will not yet be adapted to create care plans for them.
- Persons who were diagnosed with cancer >21 years. This program is designed for survivors of pediatric cancers. Survivors of adult cancers are referred to the existing information provided by Oncolink, Oncolife and the LIVESTRONG survivorship care plans.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and Patient Satisfaction is a pilot project designed to test the feasibility and acceptability of use of an online care plan generator for adult survivors of pediatric cancers.
Because of improvements in cancer screening, diagnosis and treatment, there are an estimated 13 million cancer survivors living in the U.S. today, with projected growth to 18 million by 2020 (De Moor). These survivors include survivors of leukemia and lymphoma, as well as solid tumors including breast, colon, testicular and prostate cancers. It also include a subset of patients who are survivors of pediatric cancers, as over 80% of children diagnosed with cancer today are cured. In fact, it is estimated that 1 in every 600 young adults between the ages of 20-35 is a cancer survivor (Dreyer, Hewitt, Greenlee).
Read more
Cancer patients as a whole, despite improved cure rates, have been shown to receive inadequate medical care as survivors. Comprehensive survivorship care should include routine age appropriate medical care as well as information about prior diagnosis and treatment, and screening for recurrence of their primary malignancy as well as secondary malignancies, and screening for late effects of cancer treatment (Earle, Craig). Adult survivors of pediatric cancer, exposed to life-saving but toxic treatments during times of growth and development, are particularly prone to late effects but also have been shown to have inadequate monitoring and follow up. This is a concern as late effects of treatment are sometimes silent for years or decades after completion of cancer therapy and that adult survivors of childhood cancer, years from their diagnosis and treatment, have been shown to have alarming rates of life threatening chronic health conditions compared to their peers (Oeffinger). Thus, these late effects may emerge during adulthood when patients have moved on from the care of their primary oncologist. Complicating matters, primary care providers, who often assume the care of these patients, may not have the knowledge or tools necessary to appropriately care for survivors of childhood cancer (Suh).
National organizations have come together to identify ways to improve quality of and access to long term follow up care for adult survivors of childhood cancer. The Children's Oncology Group published Long Term Follow up guidelines which recommend lifelong risk based follow up care and screening (COG guidelines). In addition, in 2005, the Institute of Medicine published a report, From Cancer Patient to Cancer Survivor: Lost in Transition gave recommendations to improve health outcomes of cancer survivors which includes the receipt of a comprehensive care summary and follow up plan to aid in appropriate risk based follow up care (Hewitt). Despite these recommendations childhood cancer survivors knowledge about past diagnosis and treatment and engagement in follow up care is suboptimal (Kaden-Lottick, Nathan). It has been demonstrated that pediatric cancer survivors are not receiving care summaries, and thus may try to find appropriate follow up information via the other sources such as the internet (Casillas).
Oncolife, a free online tool to create survivorship care plans, was created in May 2007 (Hill 2009), and has been housed at maintained at the University of Pennsylvania since then. This tool has shown to be feasible way to provide information and care plans to survivors of adult cancers. In addition, survivors who have used the resource, state that it will, or has already, positively influenced communication about cancer related follow up with their healthcare team (Hill 2013).
The study aim is to adapt Oncolife to provide individualized information for adult survivors of childhood cancer with the unique recommendations for long term follow up for pediatric cancer survivors. Oncolife has already been collecting data on plans created by adult survivors of adult cancers and has been reviewed by the IRB previously (IRB#806368 and #811528 note: previously called Oncolink). Adaption of Oncolife to meet the needs of adult survivors of childhood cancer will improve access to high quality electronic health information as patients may find long term follow up guidelines cumbersome or largely irrelevant to their needs depending on their specific exposures. Individualizing the available information to a particular survivor will allow for better understanding of and improved adherence to recommended cancer related follow up care. We propose to develop survivorship care plans in a way that will most benefit users, thus after creation of the Smart Adult Living After Childhood Cancer care plan we will ask for patient input via survey immediately after receipt of their care plan and in a one month follow up survey.
- Conditions
- Childhood Cancer
- Being tested
- Questionniares
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionniaresOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects completing questionnaires
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Hill-Kayser, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559219
- Sponsor's protocol ID
- UPCC 36914
- Status last verified
- Apr 2020
- First submitted
- 23 Jun 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT02559219
- Acronym / sponsor ID
- UPCC 36914
- Conditions
- Childhood Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 24 Sep 2015 (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.
Smart Adult Living After Childhood Cancer (SmartALACC) Online Care Plans: Feasibility and Patient Satisfaction is a pilot project designed to test the feasibility and acceptability of use of an online care plan generator for adult survivors of pediatric cancers.
Because of improvements in cancer screening, diagnosis and treatment, there are an estimated 13 million cancer survivors living in the U.S. today, with projected growth to 18 million by 2020 (De Moor). These survivors include survivors of leukemia and lymphoma, as well as solid tumors including breast, colon, testicular and prostate cancers. It also include a subset of patients who are survivors of pediatric cancers, as over 80% of children diagnosed with cancer today are cured. In fact, it is estimated that 1 in every 600 young adults between the ages of 20-35 is a cancer survivor (Dreyer, Hewitt, Greenlee).
Cancer patients as a whole, despite improved cure rates, have been shown to receive inadequate medical care as survivors. Comprehensive survivorship care should include routine age appropriate medical care as well as information about prior diagnosis and treatment, and screening for recurrence of their primary malignancy as well as secondary malignancies, and screening for late effects of cancer treatment (Earle, Craig). Adult survivors of pediatric cancer, exposed to life-saving but toxic treatments during times of growth and development, are particularly prone to late effects but also have been shown to have inadequate monitoring and follow up. This is a concern as late effects of treatment are sometimes silent for years or decades after completion of cancer therapy and that adult survivors of childhood cancer, years from their diagnosis and treatment, have been shown to have alarming rates of life threatening chronic health conditions compared to their peers (Oeffinger). Thus, these late effects may emerge during adulthood when patients have moved on from the care of their primary oncologist. Complicating matters, primary care providers, who often assume the care of these patients, may not have the knowledge or tools necessary to appropriately care for survivors of childhood cancer (Suh).
National organizations have come together to identify ways to improve quality of and access to long term follow up care for adult survivors of childhood cancer. The Children's Oncology Group published Long Term Follow up guidelines which recommend lifelong risk based follow up care and screening (COG guidelines). In addition, in 2005, the Institute of Medicine published a report, From Cancer Patient to Cancer Survivor: Lost in Transition gave recommendations to improve health outcomes of cancer survivors which includes the receipt of a comprehensive care summary and follow up plan to aid in appropriate risk based follow up care (Hewitt). Despite these recommendations childhood cancer survivors knowledge about past diagnosis and treatment and engagement in follow up care is suboptimal (Kaden-Lottick, Nathan). It has been demonstrated that pediatric cancer survivors are not receiving care summaries, and thus may try to find appropriate follow up information via the other sources such as the internet (Casillas).
Oncolife, a free online tool to create survivorship care plans, was created in May 2007 (Hill 2009), and has been housed at maintained at the University of Pennsylvania since then. This tool has shown to be feasible way to provide information and care plans to survivors of adult cancers. In addition, survivors who have used the resource, state that it will, or has already, positively influenced communication about cancer related follow up with their healthcare team (Hill 2013).
The study aim is to adapt Oncolife to provide individualized information for adult survivors of childhood cancer with the unique recommendations for long term follow up for pediatric cancer survivors. Oncolife has already been collecting data on plans created by adult survivors of adult cancers and has been reviewed by the IRB previously (IRB#806368 and #811528 note: previously called Oncolink). Adaption of Oncolife to meet the needs of adult survivors of childhood cancer will improve access to high quality electronic health information as patients may find long term follow up guidelines cumbersome or largely irrelevant to their needs depending on their specific exposures. Individualizing the available information to a particular survivor will allow for better understanding of and improved adherence to recommended cancer related follow up care. We propose to develop survivorship care plans in a way that will most benefit users, thus after creation of the Smart Adult Living After Childhood Cancer care plan we will ask for patient input via survey immediately after receipt of their care plan and in a one month follow up survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any person who has received a cancer diagnosis of acute lymphoblastic leukemia (ALL) or Hodgkins lymphoma (HL) before the age of 21 and now is 15 years or older and is now off therapy (considered in remission).
Key inclusion criteria (4 listed)
- Patients with a cancer diagnosis of acute lymphoblastic leukemia or Hodgkin's lymphoma
- Diagnosis before age 21 years
- Currently off therapy and considered in remission
- Currently 15 years or older
Key exclusion criteria (2 listed)
- Persons who have never had cancer or who have another pediatric malignancy (Wilms tumor, neuroblastoma) as the website will not yet be adapted to create care plans for them.
- Persons who were diagnosed with cancer >21 years. This program is designed for survivors of pediatric cancers. Survivors of adult cancers are referred to the existing information provided by Oncolink, Oncolife and the LIVESTRONG survivorship care plans.
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 |
|---|---|---|
| Questionniares | Other | – |
Primary outcome
Number of subjects completing questionnaires
Time frame: 2 years
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 24 Apr 2020.
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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.
Christine Hill-Kayser, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 Childhood Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 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 24 Apr 2020. 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?
Number of subjects completing questionnaires (time frame: 2 years). 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 24 Apr 2020.