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Cancer Prevention Mastery Model Internet Intervention


N/A
18 Years
63 Years
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Cancer Prevention Mastery Model Internet Intervention


OBJECTIVES:

- Compare the efficacy of an internet-based mastery-model health behavior educational
intervention vs internet-based standard care health behavior educational intervention
in improving physical activity and nutrition in sedentary participants with a higher
body mass index.

- Compare the efficacy of these interventions in reducing cancer risk, in these
participants.

OUTLINE: This is a randomized, controlled, multicenter study. Participants are stratified
according to participating site, age (55 years and over vs under 55 years), gender, ethnic
group, and aerobic capacity (≤ 6 metabolic equivalent tasks [METS] vs > 6 METS).
Participants are randomized to 1 of 2 intervention arms.

- Arm I (mastery model health behavior educational intervention): Participants log on to
the Guide to Health Project (GTH) website weekly and are provided access over a
24-month period to healthy lifestyle coaching modules and a completely individualized
fitness program organized according to a mastery-model health behavior educational
intervention. The mastery-model intervention comprises a 6-month behavioral initiation
phase that includes an orientation and refinement of goals and expectations for each
content area; a 6-month behavioral establishment phase comprising healthy lifestyle
coaching modules focusing on physical activity and nutrition at least once a week; and
a 6-month behavioral maintenance phase comprising a taper in the frequency of coaching
sessions to once a month.

- Arm II (standard care health behavior educational intervention): Participants log on to
the GTH website weekly and are provided access over a 24-month period to information
regarding a healthy lifestyle focusing on physical activity and nutrition organized
according to a standard care health behavior educational intervention.

In both arms, participants verify step-counts measured by a pedometer and complete the Block
Food Frequency Questionnaire online at 10 and 18 months.

PROJECTED ACCRUAL: A total of 300 participants (150 per arm) will be accrued for this study
within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Sedentary participant

- Not currently participating in a regular exercise program (i.e., < 30
minutes/day of moderate physical activity, 5 days a week)

- Body Mass Index 23-33.5

- Patiwnts that meet any of the following criteria are excluded:

- High blood pressure (BP) (i.e., systolic BP ≥ 140 mm Hg OR diastolic BP ≥ 90 mm
Hg) OR BP controlled with medications other than beta-blockers

- Known high cholesterol (i.e., > 200 mg/dL)

- Known low high-density lipoprotein level (i.e., < 40 mg/dL)

- Use of antihyperlipidemic medications

- Existing disease (i.e., heart disease, cancer, diabetes, and kidney or liver
problems)

PATIENT CHARACTERISTICS:

Age

- 18 to 63

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No known liver disease

Renal

- No known kidney disease

Cardiovascular

- See Disease Characteristics

- No known cardiovascular disease

- Blood pressure ≤ 140/90 mm Hg

Pulmonary

- No known pulmonary disease

Other

- Not pregnant

- No known diabetes

- No known HIV positivity

- No cancer within the past 5 years

- No condition (e.g., orthopedic injuries or musculoskeletal disabilities) that would
restrict physical activity or the ability to take a 1-mile walk test

- No other known life-threatening illness or condition

- Internet user

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- No prior organ transplantation

Other

- No concurrent beta-blockers

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Richard A. Winett, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Polytechnic Institute and State University

Authority:

Unspecified

Study ID:

CDR0000441158

NCT ID:

NCT00128570

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Virginia Polytechnic Institute and State UniversityBlacksburg, Virginia  24061