Skin CarcinomaNCT04358276
Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study
A study testing Computer-Assisted Intervention, Dermatoscope and Educational Intervention in people with Skin Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This trial studies the impact of a 12-month invention focused on early detection of skin cancer and timely follow up in patients who underwent stem cell transplant and their primary care providers. Some stem cell transplant survivors may develop complications related to the treatment they received. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Carcinoma
- What is being tested?
- Computer-Assisted Intervention, Dermatoscope and Educational Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have undergone autologous or allogeneic hematopoietic stem cell transplantation (HCT) at City of Hope (COH)
- Are 2 years (yrs) to 5 yrs (+/- 3 months [m]) after HCT
- Have seen a primary care provider (PCP) in the previous 12 m (expected > 95% of all eligible) or planning to do so in next 12 m
- Have a mobile phone with the ability to receive text messages
- Can fluently read and write in English or Spanish
- Can understand and sign the study-specific Informed Consent Form (ICF)
Who cannot join
- Patients who have evidence of active hematologic malignancy or acute illness that would limit study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Technology-Enabled Activation of Skin Cancer Screening for Hematopoietic Cell Transplantation Survivors and Their Primary Care Providers (TEACH)
This trial studies the impact of a 12-month invention focused on early detection of skin cancer and timely follow up in patients who underwent stem cell transplant and their primary care providers. Some stem cell transplant survivors may develop complications related to the treatment they received. Many of these complications may not be known for years after the treatment and preventive measures can be taken to reduce the chances that a complication will occur and encourage early detection. This study focuses on one complication that stem cell transplant survivors are at high risk of developing - skin cancer. An early diagnosis of skin cancer is important since the cancer is usually smaller, requires less extensive treatments, and has better outcomes. Teaching skin self-examination and encouraging patients to alert doctors to skin changes may provide an important opportunity for early detection of skin cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the impact of patient activation and education (PAE, N=360) alone or with physician activation (PAE+Phys, N=360) on skin cancer screening and health promotion practices at 12 months, measured by percentage of survivors who conduct skin self-exam and receive physician skin exam, and time to detection and diagnosis of suspicious lesions.
II. Among primary care physicians of transplant patients, determine the impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.
GROUP II: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit.
GROUP III: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice.
- Conditions
- Skin Carcinoma
- Being tested
- Computer-Assisted Intervention, Dermatoscope, Educational Intervention, Educational Intervention (Physician), Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted InterventionOther
Complete online course
DermatoscopeDevice
Receive dermatoscope
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive study packet
Educational Intervention (Physician)Other
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive physician directed letter and educational package
Questionnaire AdministrationOther
Ancillary studies
Text MessageOther
Also called SMS Text, SMS Text Message, Text
Receive text messages
| Study group | Role | What they receive |
|---|---|---|
| Group I (PAE) | Experimental | Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Receives: Other: Educational Intervention; Other: Questionnaire Administration; Other: Text Message |
| Group II (PAE, physician) | Experimental | Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Receives: Other: Educational Intervention; Other: Educational Intervention (Physician); Other: Questionnaire Administration; Other: Text Message |
| Group III (PAE, physician, dermatoscope) | Experimental | Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice. Receives: Other: Computer-Assisted Intervention; Device: Dermatoscope; Other: Educational Intervention; Other: Educational Intervention (Physician); Other: Questionnaire Administration; Other: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of patient activation and education alone or with physician activation on change in skin cancer screening and health promotion practices
Will administer questionnaires at baseline and 12 months to ask about skin examinations performed within the past 12 months. Will use logistic regression to adjust for imbalance in patient characteristics and risk factors. Will also test for group by covariate interactions, depending on group main effect.
Measured: Baseline and 12 months
Time interval between a participant's first notice of a suspect mole or lesion and the date on which a definitive diagnosis was made
Will be a continuous variable, and will employ a generalized linear model to compare the interval between the two study arms, adjusted for covariates of interest. Will begin with bivariate models to determine potential variables to include in a multivariable regression model. If the group main effect is significant, interactions of the group main effect with other variables will be examined.
Measured: Up to 12 months
Impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions
Will compare the group difference in changes in attitude over time, using generalized estimating equation (GEE) for normally distributed data, with a compound symmetry covariance matrix analysis to account for within-physician correlation. Will dichotomize the Likert scale (1-5) response and compare the proportion of primary care physicians (PCPs) reporting a higher (>= 4 versus < 4) level of confidence at 12 months (m) compared to baseline between groups, using the longitudinal binomial GEE model with a compound symmetry covariance structure. Covariate adjustment will be made in these models as necessary.
Measured: Up to 12 months
Economic impact on patients - cost-effectiveness analysis
Evaluated using standard incremental cost-effectiveness analysis methods will be used to assess the impact of assumptions and uncertainty on results and conclusions.
Measured: Up to 12 months
Economic impact on patients - sensitivity analysis
Evaluated using standard incremental sensitivity analysis will be used to assess the impact of assumptions and uncertainty on results and conclusions.
Measured: Up to 12 months
Downstream costs
Will estimate the cost per additional self skin exam completed and the cost per additional PCP exam completed, comparing the two intervention arms.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 Oct 2020
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saro H Armenian, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358276
- Sponsor's protocol ID
- 20096
- Other IDs
- NCI-2020-01830, 20096
- Status last verified
- May 2026
- First submitted
- 7 Apr 2020
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Armenian SH, Du X, Bosworth A, Rodarte S, Balasian E, Boyapalli S, Herrera C, Echevarria M, Lindenfeld L, Al Malki M, Nakamura R, Modi B, Oeffinger KC, Emmons KM, Marghoob AA, Forman SJ, Wong FL, Geller AC. Technology-Enabled Patient and Physician Activation to Enhance Skin Cancer Screening After HCT: A Randomized Controlled Trial. J Natl Compr Canc Netw. 2026 Aug 6:1-8. doi: 10.6004/jnccn.2026.7030. Online ahead of print.
PubMed 42562001Armenian SH, Lindenfeld L, Iukuridze A, Echevarria M, Bebel S, Coleman C, Nakamura R, Abdullah F, Modi B, Oeffinger KC, Emmons KM, Marghoob AA, Geller AC. Technology-enabled activation of skin cancer screening for hematopoietic cell transplantation survivors and their primary care providers (TEACH). BMC Cancer. 2020 Aug 3;20(1):721. doi: 10.1186/s12885-020-07232-2.
PubMed 32746799
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Activation of Skin Cancer Screening for Hematopoietic Cell Transplantation Survivors and Their Primary Care Providers (TEACH)
- ClinicalTrials.gov ID
- NCT04358276
- Acronym / sponsor ID
- 20096
- Conditions
- Skin Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Apr 2020 (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 trial studies the impact of a 12-month invention focused on early detection of skin cancer and timely follow up in patients who underwent stem cell transplant and their primary care providers. Some stem cell transplant survivors may develop complications related to the treatment they received. Many of these complications may not be known for years after the treatment and preventive measures can be taken to reduce the chances that a complication will occur and encourage early detection. This study focuses on one complication that stem cell transplant survivors are at high risk of developing - skin cancer. An early diagnosis of skin cancer is important since the cancer is usually smaller, requires less extensive treatments, and has better outcomes. Teaching skin self-examination and encouraging patients to alert doctors to skin changes may provide an important opportunity for early detection of skin cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine the impact of patient activation and education (PAE, N=360) alone or with physician activation (PAE+Phys, N=360) on skin cancer screening and health promotion practices at 12 months, measured by percentage of survivors who conduct skin self-exam and receive physician skin exam, and time to detection and diagnosis of suspicious lesions.
II. Among primary care physicians of transplant patients, determine the impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.
GROUP II: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit.
GROUP III: Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (PAE) | Experimental | Other: Educational Intervention, Other: Questionnaire Administration, Other: Text MessageParticipants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. |
| Group II (PAE, physician) | Experimental | Other: Educational Intervention, Other: Educational Intervention (Physician), Other: Questionnaire Administration, Other: Text MessageParticipants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. |
| Group III (PAE, physician, dermatoscope) | Experimental | Other: Computer-Assisted Intervention, Device: Dermatoscope, Other: Educational Intervention, Other: Educational Intervention (Physician), Other: Questionnaire Administration, Other: Text MessageParticipants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months. Participants' physician receives a letter that describes the educational intervention and encourages them to do a skin examination at next patient visit. Physicians also receive a free dermatoscope with instructions for uploading images of suspect lesions and attend a 30-minute online course comprising additional descriptions of dermoscopic images for skin cancers and "mimickers" common in hematopoietic stem cell transplantation patients, along with clear instructions for using a dermatoscope and steps to integrate dermoscopy into their practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have undergone autologous or allogeneic hematopoietic stem cell transplantation (HCT) at City of Hope (COH)
- Are 2 years (yrs) to 5 yrs (+/- 3 months [m]) after HCT
- Have seen a primary care provider (PCP) in the previous 12 m (expected > 95% of all eligible) or planning to do so in next 12 m
- Have a mobile phone with the ability to receive text messages
- Can fluently read and write in English or Spanish
Key exclusion criteria (1 listed)
- Patients who have evidence of active hematologic malignancy or acute illness that would limit study participation
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 |
|---|---|---|
| Computer-Assisted InterventionComplete online course | Other | Group III (PAE, physician, dermatoscope) |
| DermatoscopeReceive dermatoscope | Device | Group III (PAE, physician, dermatoscope) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive study packet | Other | Group I (PAE), Group II (PAE, physician), Group III (PAE, physician, dermatoscope) |
| Educational Intervention (Physician)Also: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive physician directed letter and educational package | Other | Group II (PAE, physician), Group III (PAE, physician, dermatoscope) |
| Questionnaire AdministrationAncillary studies | Other | Group I (PAE), Group II (PAE, physician), Group III (PAE, physician, dermatoscope) |
| Text MessageAlso: SMS Text, SMS Text Message, TextReceive text messages | Other | Group I (PAE), Group II (PAE, physician), Group III (PAE, physician, dermatoscope) |
Primary outcome
Impact of patient activation and education alone or with physician activation on change in skin cancer screening and health promotion practices
Time frame: Baseline and 12 months
Will administer questionnaires at baseline and 12 months to ask about skin examinations performed within the past 12 months. Will use logistic regression to adjust for imbalance in patient characteristics and risk factors. Will also test for group by covariate interactions, depending on group main effect.
Time interval between a participant's first notice of a suspect mole or lesion and the date on which a definitive diagnosis was made
Time frame: Up to 12 months
Will be a continuous variable, and will employ a generalized linear model to compare the interval between the two study arms, adjusted for covariates of interest. Will begin with bivariate models to determine potential variables to include in a multivariable regression model. If the group main effect is significant, interactions of the group main effect with other variables will be examined.
Impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions
Time frame: Up to 12 months
Will compare the group difference in changes in attitude over time, using generalized estimating equation (GEE) for normally distributed data, with a compound symmetry covariance matrix analysis to account for within-physician correlation. Will dichotomize the Likert scale (1-5) response and compare the proportion of primary care physicians (PCPs) reporting a higher (>= 4 versus < 4) level of confidence at 12 months (m) compared to baseline between groups, using the longitudinal binomial GEE model with a compound symmetry covariance structure. Covariate adjustment will be made in these models as necessary.
Economic impact on patients - cost-effectiveness analysis
Time frame: Up to 12 months
Evaluated using standard incremental cost-effectiveness analysis methods will be used to assess the impact of assumptions and uncertainty on results and conclusions.
Economic impact on patients - sensitivity analysis
Time frame: Up to 12 months
Evaluated using standard incremental sensitivity analysis will be used to assess the impact of assumptions and uncertainty on results and conclusions.
Downstream costs
Time frame: Up to 12 months
Will estimate the cost per additional self skin exam completed and the cost per additional PCP exam completed, comparing the two intervention arms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42562001Armenian SH, Du X, Bosworth A, Rodarte S, Balasian E, Boyapalli S, Herrera C, Echevarria M, Lindenfeld L, Al Malki M, Nakamura R, Modi B, Oeffinger KC, Emmons KM, Marghoob AA, Forman SJ, Wong FL, Geller AC. Technology-Enabled Patient and Physician Activation to Enhance Skin Cancer Screening After HCT: A Randomized Controlled Trial. J Natl Compr Canc Netw. 2026 Aug 6:1-8. doi: 10.6004/jnccn.2026.7030. Online ahead of print.
- Derived from this study: PubMed 32746799Armenian SH, Lindenfeld L, Iukuridze A, Echevarria M, Bebel S, Coleman C, Nakamura R, Abdullah F, Modi B, Oeffinger KC, Emmons KM, Marghoob AA, Geller AC. Technology-enabled activation of skin cancer screening for hematopoietic cell transplantation survivors and their primary care providers (TEACH). BMC Cancer. 2020 Aug 3;20(1):721. doi: 10.1186/s12885-020-07232-2.
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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.
Saro H Armenian principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Intervention, Dermatoscope and Educational Intervention in people with Skin Carcinoma, run by City of Hope Medical Center 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 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Impact of patient activation and education alone or with physician activation on change in skin cancer screening and health promotion practices (time frame: Baseline and 12 months). The study lists 6 primary outcomes in all. 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 NCT04358276, 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 25 Jun 2026.