Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: An internet-based health behavior program that provides information about physical activity, fitness, and nutrition may help participants become healthier and reduce the risk of developing cancer. PURPOSE: This randomized clinical trial is studying an individualized internet-based health behavior program to see how well it works compared to a standard internet-based health behavior program in preventing cancer and improving physical activity, fitness, and nutrition in participants who are physically inactive with a higher body mass index.
Detailed description
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.
Interventions
PROCEDUREevaluation of cancer risk factors
OTHERinternet-based intervention
BEHAVIORALbehavioral dietary intervention
OTHEReducational intervention
Sponsors
National Cancer Institute (NCI)
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
18 Years to 63 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed