Breast Cancer Screening Via Computer V. Phone

Indiana University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer Screening

Treatments: Behavioral: Tailored, interactive intervention for mammography screening

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00287040

NIH: R01 NR0083434

R01NR008434 (U.S. NIH Grant/Contract)

0408-03B

Details and patient eligibility

About

The purpose of this study is to compare mammography adherence among women receiving tailored, interactive mammography interventions via DVD and telephone counseling to usual care.

Full description

Efficacy Study - We will use stratified block randomization based on race to ensure that the treatment groups maintain comparable race composition. Participants will be randomly assigned to one of the intervention groups or to usual care. Intervention Group 1 will receive, by mail, a DVD version of the interactive computer program; based on responses to its queries, the program will supply immediate feedback to promote mammography. Intervention Group 2 will receive a telephone version of the tailored intervention delivered by a counselor stationed at a computer. The counselor will use questions from the interactive program and deliver messages the program generates in response to each woman's answers. A third group will receive usual care. All women will be asked to participate in 6-month and 21-month follow-up telephone interviews querying stage of mammography adherence and beliefs.

Enrollment: 1,686 patients

Sex: Female

Ages: 41 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Must have been a member of their HMO/insurance plan for at least 15 months with records indicating no mammogram (screening or diagnostic) in that 15-month period

  • Current member of the plan at time of study enrollment
  • No history of breast cancer diagnosis
  • Complete telephone number and mailing address

Exclusion criteria

• • Any claim submitted for a mammogram (screening or diagnostic) in the last 15 months within the HMO/insurance plan or an outside source

  • Previous breast cancer diagnosis
  • Incomplete telephone number or mailing address

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,686 participants in 3 patient groups

1 - Usual Care

No Intervention group

Description:

This arm looks at mammogram adherence in those individuals who at this time are not receiving booster mammogram interventions.

2. DVD Intervention

Experimental group

Description:

This arm will receive the initial information provided in usual care and will also receive booster mammography interventions via DVD.

Treatment:

Behavioral: Tailored, interactive intervention for mammography screening

3. Telephone Counseling

Experimental group

Description:

This arm will receive the initial information provided in usual care and receive boosters through tailored telephone counseling.

Treatment:

Behavioral: Tailored, interactive intervention for mammography screening