Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study

NCT04358276 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: 20096NCI-2020-0183038249
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Up to 12 months

Study Arms (3)

Group I (PAE)

EXPERIMENTAL

Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.

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.

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.

Other: Computer-Assisted Intervention; Device: Dermatoscope; Other: Educational Intervention; Other: Educational Intervention (Physician); Other: Questionnaire Administration; Other: Text Message

Interventions

Dermatoscope DEVICE

Receive dermatoscope

Group III (PAE, physician, dermatoscope)

Educational Intervention OTHER

Receive study packet

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (PAE); Group II (PAE, physician); Group III (PAE, physician, dermatoscope)

Questionnaire Administration OTHER

Ancillary studies

Group I (PAE); Group II (PAE, physician); Group III (PAE, physician, dermatoscope)

Text Message OTHER

Receive text messages

Also known as: SMS Text, SMS Text Message, Text

Group I (PAE); Group II (PAE, physician); Group III (PAE, physician, dermatoscope)

Computer-Assisted Intervention OTHER

Complete online course

Group III (PAE, physician, dermatoscope)

Educational Intervention (Physician) OTHER

Receive physician directed letter and educational package

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group II (PAE, physician); Group III (PAE, physician, dermatoscope)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients who have evidence of active hematologic malignancy or acute illness that would limit study participation

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• Armenian 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.

  PMID: 32746799 DERIVED

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods; Physicians; Communication Devices for People with Disabilities

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Health Personnel; Self-Help Devices; Equipment and Supplies

Study Officials

• Saro H Armenian

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 24, 2020
• Study Start: October 30, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)