Clinical trial NCT04358276: Technology-Enabled Activation of Skin Cancer Screening for Stem Cell Transplant Survivors and Their Primary Care Providers, TEACH Study
Official title: Technology-Enabled Activation of Skin Cancer Screening for Hematopoietic Cell Transplantation Survivors and Their Primary Care Providers (TEACH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-24
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of patient activation and education alone or with physician activation on change in skin cancer screening and health promotion practices
timeFrame: Baseline and 12 months
measure: Time interval between a participant's first notice of a suspect mole or lesion and the date on which a definitive diagnosis was made
timeFrame: Up to 12 months
measure: Impact of an e-learning teledermoscopy program compared with provision of print materials for identifying suspect lesions
timeFrame: Up to 12 months
measure: Economic impact on patients - cost-effectiveness analysis
timeFrame: Up to 12 months
measure: Economic impact on patients - sensitivity analysis
timeFrame: Up to 12 months
measure: Downstream costs
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Saro H Armenian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.