Clinical trial NCT00287040: Breast Cancer Screening Via Computer V. Phone
Official title: Breast Cancer Screening Via Computer V. Phone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer Screening
Keywords: Breast Cancer
Mammography
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Cancer Institute (NCI)
First posted: 2006-02-06
Enrollment: 1686
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To increase annual mammography adherence
timeFrame: at 6-, 12-, and 21-Months
Secondary outcomes:
measure: Cost-effectiveness of DVD versus telephone survey
timeFrame: at 6-, 12-, and 21-months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Indiana University
name: Victoria Champion, DNS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gathirua-Mwangi WG, Monahan PO, Stump T, Rawl SM, Skinner CS, Champion VL. Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial. Ann Behav Med. 2016 Feb;50(1):70-8. doi: 10.1007/s12160-015-9733-0.
citation: Champion VL, Rawl SM, Bourff SA, Champion KM, Smith LG, Buchanan AH, Fish LJ, Monahan PO, Stump TE, Springston JK, Gathirua-Mwangi WG, Skinner CS. Randomized trial of DVD, telephone, and usual care for increasing mammography adherence. J Health Psychol. 2016 Jun;21(6):916-26. doi: 10.1177/1359105314542817. Epub 2014 Jul 28.