Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of some types of cancer. Dietary counseling may be effective in helping women change to a healthy diet. PURPOSE: This randomized clinical trial is studying how well individual counseling and/or computer-based counseling work in helping healthy women adopt a cancer prevention diet.
Detailed description
OBJECTIVES: * Compare 3-, 12-, and 18-month changes in self-reported daily servings of fruits and vegetables and percent of energy from fat in healthy women undergoing dietary modification intervention comprising in-person individualized counseling vs automated computer-based counseling vs both dietary modification interventions vs automated computer-based physical activity counseling (control). * Compare the efficacy and long-term effects of these interventions in these participants. * Compare participant acceptance of these interventions, in terms of the proportion and characteristics (e.g., age and race) of participants who accept the intervention and participate in intervention activities. * Compare initial dietary change, in terms of dietary habits, socio-demographics, and self-efficacy, in participants undergoing these interventions. * Compare the maintenance of dietary change, in terms of demographics, self efficacy, and perceived community environmental support, in participants undergoing these interventions. * Compare the cost of delivering these interventions to these participants. * Compare the cost of these interventions when used in routine practice. OUTLINE: This is a randomized study. Participants are randomized to 1 of 4 arms. * Arm I (in-person individualized dietary modification counseling): Participants undergo in-person individualized counseling in weeks 0 and 3 and receive a phone call by a counselor in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy. * Arm II (automated computer-based dietary modification counseling): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy. * Arm III (in-person individualized and automated computer-based dietary modification counseling): Participants undergo in-person individualized counseling and automated computer-based counseling in weeks 0 and 3 and receive a phone call by a counselor in week 6 and an automated phone call in weeks 1 and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reduce fat intake to no more than 25% of energy. * Arm IV (automated computer-based physical activity counseling \[control\]): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily physical activity to a moderate amount (20-30 minutes per day). After study completion, patients are followed at 3, 12, and 18 months. PROJECTED ACCRUAL: A total of 600 participants (150 per arm) will be accrued for this study within 2 years.
Interventions
An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan
An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Healthy participant * Not undergoing care for cancer * Kaiser Permanente health plan member for at least 2 years * No current dietary goals * No diet comprising an average consumption of \> 4 combined servings of fruits and vegetables per day and/or fat consumption below 30% of total energy * No physician-prescribed diets PATIENT CHARACTERISTICS: Age * 30 to 70 Sex * Female Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | Baseline and 3 months | Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months. |
| Change in Percentage of Fat Consumed | Baseline and 3 months | Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months. |
Countries
United States
Participant flow
Recruitment details
Women in Kaiser Permanente were identified from the electronic medical record and sent a letter inviting them to participate in the study. Recruitment started in 2003
Pre-assignment details
Women who agreed to come in for the initial visit and randomization were excluded if they were not willing to change diet or physical activity, could not speak and read English.
Participants by arm
| Arm | Count |
|---|---|
| Computer Only Dietary Counseling delivered by interactive computer | 154 |
| Counseling Only Dietary counseling delivered by nutritionist | 153 |
| Combined Dietary counseling delivered using computer program and nutritionist | 155 |
| Physcial Activity-computer Physical activity counseling delivered by computer only | 153 |
| Total | 615 |
Baseline characteristics
| Characteristic | Counseling Only | Combined | Physcial Activity-computer | Total | Computer Only |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 12 Participants | 9 Participants | 41 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants | 143 Participants | 144 Participants | 574 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 4 Participants | 19 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants | 147 Participants | 146 Participants | 586 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 3 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 1 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 16 Participants | 48 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 6 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) White | 131 Participants | 135 Participants | 129 Participants | 527 Participants | 132 Participants |
| Region of Enrollment United States | 153 participants | 155 participants | 153 participants | 615 participants | 154 participants |
| Sex: Female, Male Female | 153 Participants | 155 Participants | 153 Participants | 615 Participants | 154 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 154 | 0 / 153 | 0 / 155 | 0 / 153 |
| serious Total, serious adverse events | 0 / 154 | 0 / 153 | 0 / 155 | 0 / 153 |
Outcome results
Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Time frame: Baseline and 3 months
Population: Participant who returned for follow up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer Only | Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | 2.7272727 number of servings per day | Standard Deviation 2.7480483 |
| Counseling Only | Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | 2.9758065 number of servings per day | Standard Deviation 2.8426456 |
| Combined | Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | 2.7330645 number of servings per day | Standard Deviation 2.7742053 |
| Physcial Activity-computer | Change in Fruit, Vegetable Consumption as Measured by Food Frequency Questionnaire at 3 Months | 0.4720000 number of servings per day | Standard Deviation 2.2229594 |
Change in Percentage of Fat Consumed
Self reported dietary change in consumption as collected via Block Food Frequency Questionnaire (FFQ) servings of fruit or vegetable per day and average fat consumption. This FFQ asks participants to recall their average consumption of various categories of food during the previous three months.
Time frame: Baseline and 3 months
Population: Participants who returned for follow up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Computer Only | Change in Percentage of Fat Consumed | -4.653333 Percentage of fat consumed | Standard Deviation 7.4788051 |
| Counseling Only | Change in Percentage of Fat Consumed | -5.3439516 Percentage of fat consumed | Standard Deviation 7.3594025 |
| Combined | Change in Percentage of Fat Consumed | -6.0113710 Percentage of fat consumed | Standard Deviation 6.9703683 |
| Physcial Activity-computer | Change in Percentage of Fat Consumed | -1.4154400 Percentage of fat consumed | Standard Deviation 7.9831426 |