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

City of Hope logo

City of Hope

Status

Active, not recruiting

Conditions

Skin Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04358276
20096 (Other Identifier)
38249 (Other Identifier)
NCI-2020-01830 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

840 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

840 participants in 3 patient groups

Group I (PAE)
Experimental group
Description:
Participants receive a study packet on skin cancer. Participants also receive text messages once every 3 weeks for 9 months.
Treatment:
Other: Text Message
Other: Questionnaire Administration
Other: Educational Intervention
Group II (PAE, physician)
Experimental group
Description:
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.
Treatment:
Other: Text Message
Other: Questionnaire Administration
Other: Educational Intervention
Other: Educational Intervention (Physician)
Group III (PAE, physician, dermatoscope)
Experimental group
Description:
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.
Treatment:
Other: Text Message
Other: Computer-Assisted Intervention
Other: Questionnaire Administration
Device: Dermatoscope
Other: Educational Intervention
Other: Educational Intervention (Physician)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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