Cancer Prevention Mastery Model Internet Intervention
18 Years
63 Years
Both
Unspecified Adult Solid Tumor, Protocol Specific
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 University | Blacksburg, Virginia 24061 |
