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

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: Recruiting
• Conditions: Skin Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Text Message; Other: Educational Intervention; Other: Educational Intervention (Physician); Other: Computer-Assisted Intervention; Device: Dermatoscope

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 (Anticipated): 720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Saro H. Armenian; Phone Number: 800-826-4673; Email: sarmenian@coh.org
      • Principal Investigator: Saro H. Armenian

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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.	Other: Questionnaire Administration; Ancillary studies; Other: Text Message; Receive text messages; Other Names: Text; SMS Text; SMS Text Message; Other: Educational Intervention; Receive study packet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
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.	Other: Questionnaire Administration; Ancillary studies; Other: Text Message; Receive text messages; Other Names: Text; SMS Text; SMS Text Message; Other: Educational Intervention; Receive study packet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention (Physician); Receive physician directed letter and educational package; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
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.	Other: Questionnaire Administration; Ancillary studies; Other: Text Message; Receive text messages; Other Names: Text; SMS Text; SMS Text Message; Other: Educational Intervention; Receive study packet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention (Physician); Receive physician directed letter and educational package; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Computer-Assisted Intervention; Complete online course; Device: Dermatoscope; 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	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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Saro H Armenian, City of Hope Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): March 31, 2025

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): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 20096 (Other Identifier: City of Hope Medical Center); NCI-2020-01830 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 38249 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes