Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study
June 23, 2026 updated by: City of Hope Medical Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Interventional
Enrollment (Actual)
840
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients who have evidence of active hematologic malignancy or acute illness that would limit study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (PAE)
Participants receive a study packet on skin cancer.
Participants also receive text messages once every 3 weeks for 9 months.
|
Ancillary studies
Receive text messages
Other Names:
Receive study packet
Other Names:
|
|
Experimental: Group II (PAE, physician)
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.
|
Ancillary studies
Receive text messages
Other Names:
Receive study packet
Other Names:
Receive physician directed letter and educational package
Other Names:
|
|
Experimental: Group III (PAE, physician, dermatoscope)
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.
|
Ancillary studies
Receive text messages
Other Names:
Receive study packet
Other Names:
Receive physician directed letter and educational package
Other Names:
Complete online course
Receive dermatoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
Up to 12 months
|
|
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.
|
Up to 12 months
|
|
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.
|
Up to 12 months
|
|
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.
|
Up to 12 months
|
|
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.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Saro H Armenian, City of Hope Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2020
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
April 7, 2020
First Submitted That Met QC Criteria
April 20, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 25, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Skin Neoplasms
- Investigative Techniques
- Equipment and Supplies
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Health Personnel
- Self-Help Devices
- Methods
- Early Intervention, Educational
- Educational Status
- Physicians
- Communication Devices for People with Disabilities
Other Study ID Numbers
- 20096 (Other Identifier: City of Hope Medical Center)
- NCI-2020-01830 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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