Skin NeoplasmsNCT02046811
Reducing Skin Cancer Risk in Childhood Cancer Survivors
A study testing Patient activation and education (PAE), PAE plus physician activation (PAE + MD) and PAE physician activation, plus teledermoscopy (PAE +MD +TD) in people with Skin Neoplasms, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- Patient activation and education (PAE), PAE plus physician activation (PAE + MD) and PAE physician activation, plus teledermoscopy (PAE +MD +TD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 1 Jan 2018
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- treated with radiation for a childhood cancer
- have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
- have a phone that can receive text messages
- have access to a dermlite compatible smartphone or tablet
Who cannot join
- personal history of a skin cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.
Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.
Read the detailed description
There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.
- Conditions
- Skin Neoplasms
- Being tested
- Patient activation and education (PAE), PAE plus physician activation (PAE + MD), PAE physician activation, plus teledermoscopy (PAE +MD +TD)
- Keywords
- Skin neoplasms, Radiation, Screening, Self-examination, Comparative effectiveness research, Dermoscopy
- Medical subject headings
- Skin Neoplasms, Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient activation and education (PAE)Behavioural
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
PAE plus physician activation (PAE + MD)Behavioural
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients
PAE physician activation, plus teledermoscopy (PAE +MD +TD)Behavioural
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens
| Study group | Role | What they receive |
|---|---|---|
| Patient activation and education | Experimental | Patient activation and education (PAE) Receives: Behavioral: Patient activation and education (PAE) |
| PAE plus physician activation | Experimental | PAE plus physician activation (PAE + MD) Receives: Behavioral: PAE plus physician activation (PAE + MD) |
| PAE, MD, plus teledermoscopy | Experimental | PAE physician activation, plus teledermoscopy (PAE +MD +TD) Receives: Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient thorough skin self-examination (TSSE)
Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.
Measured: 18 months
Secondary outcomes (2)
Completion of a physician skin exam
Completion of a physician skin exam will be assessed by participant report and chart review.
Measured: 18 months
Shorter time interval to diagnostic visit
A shorter time interval between the first finding of a suspect lesion after randomization and a diagnostic visit will be assessed by participant report and chart review.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Emory University
- Responsible party
- Principal investigator, Alan Geller, Harvard School of Public Health (HSPH)
- Investigators
- Alan Geller, RN, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046811
- Sponsor's protocol ID
- 1R01CA175231
- Other IDs
- R01CA175231
- Status last verified
- Jun 2018
- First submitted
- 22 Jan 2014
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Geller AC, Coroiu A, Keske RR, Haneuse S, Davine JA, Emmons KM, Daniel CL, Gibson TM, McDonald AJ, Robison LL, Mertens AC, Elkin EB, Marghoob A, Armstrong GT. Advancing Survivors Knowledge (ASK Study) of Skin Cancer Surveillance After Childhood Cancer: A Randomized Controlled Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2023 Apr 20;41(12):2269-2280. doi: 10.1200/JCO.22.00408. Epub 2023 Jan 9.
PubMed 36623247Daniel CL, Armstrong GT, Keske RR, Davine JA, McDonald AJ, Sprunck-Harrild KM, Coleman C, Haneuse SJ, Mertens AC, Emmons KM, Marghoob AA, Elkin EB, Dusza SW, Robison LL, Geller AC. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial. Trials. 2015 Mar 24;16:109. doi: 10.1186/s13063-015-0637-x.
PubMed 25873142
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Skin Cancer Risk in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT02046811
- Acronym / sponsor ID
- 1R01CA175231
- Conditions
- Skin Neoplasms
- Keywords
- Skin neoplasms, Radiation, Screening, Self-examination, Comparative effectiveness research, Dermoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Cancer Institute (NCI), St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Emory University
- Study start
- Mar 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 28 Jan 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.
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.
Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.
Detailed description
There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient activation and education | Experimental | Behavioral: Patient activation and education (PAE)Patient activation and education (PAE) |
| PAE plus physician activation | Experimental | Behavioral: PAE plus physician activation (PAE + MD)PAE plus physician activation (PAE + MD) |
| PAE, MD, plus teledermoscopy | Experimental | Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD)PAE physician activation, plus teledermoscopy (PAE +MD +TD) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- treated with radiation for a childhood cancer
- have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
- have a phone that can receive text messages
- have access to a dermlite compatible smartphone or tablet
Key exclusion criteria (1 listed)
- personal history of a skin cancer diagnosis
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 |
|---|---|---|
| Patient activation and education (PAE)Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface) | Behavioural | Patient activation and education |
| PAE plus physician activation (PAE + MD)Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients | Behavioural | PAE plus physician activation |
| PAE physician activation, plus teledermoscopy (PAE +MD +TD)Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens | Behavioural | PAE, MD, plus teledermoscopy |
Primary outcome
Patient thorough skin self-examination (TSSE)
Time frame: 18 months
Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.
2 secondary outcomes
Completion of a physician skin exam
Time frame: 18 months
Shorter time interval to diagnostic visit
Time frame: 18 months
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 20 Jun 2018.
- Derived from this study: PubMed 36623247Geller AC, Coroiu A, Keske RR, Haneuse S, Davine JA, Emmons KM, Daniel CL, Gibson TM, McDonald AJ, Robison LL, Mertens AC, Elkin EB, Marghoob A, Armstrong GT. Advancing Survivors Knowledge (ASK Study) of Skin Cancer Surveillance After Childhood Cancer: A Randomized Controlled Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2023 Apr 20;41(12):2269-2280. doi: 10.1200/JCO.22.00408. Epub 2023 Jan 9.
- Derived from this study: PubMed 25873142Daniel CL, Armstrong GT, Keske RR, Davine JA, McDonald AJ, Sprunck-Harrild KM, Coleman C, Haneuse SJ, Mertens AC, Emmons KM, Marghoob AA, Elkin EB, Dusza SW, Robison LL, Geller AC. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial. Trials. 2015 Mar 24;16:109. doi: 10.1186/s13063-015-0637-x.
- Individual participant dataSharing planned: No
Related trials for Skin Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
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.
Alan Geller, RN, MPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient activation and education (PAE), PAE plus physician activation (PAE + MD) and PAE physician activation, plus teledermoscopy (PAE +MD +TD) in people with Skin Neoplasms, run by Harvard School of Public Health (HSPH) 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 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 20 Jun 2018. 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?
Patient thorough skin self-examination (TSSE) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02046811, which also lists 2 linked publications.
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 20 Jun 2018.