Pilot Tests to Optimize the Delivery of Energy Balance Interventions
Conditions
Breast Cancer - Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Breast Cancer, Ovarian Cancer, Triple negative breast cancer, TNBC, BRCA-positive survivor, High-grade serous ovarian cancer, HGSOC, Female biological relative of a BRCA positive TNBC or HGSOC survivor, Cancer survivors, Employees at MD Anderson, Multi-phase Optimization Strategy, MOST, Energy balance interventions, EB, Telephone Coaching, Text Messaging, Social Networking, Daily Self-Monitoring, Weekly Self-Monitoring, Email Coaching, Questionnaires, Surveys
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Telephone Coaching Type: Behavioral
Name: Text Messaging Type: Behavioral
Name: Social Networking Type: Behavioral
Name: Daily Self-Monitoring Type: Behavioral
Name: Weekly Self-Monitoring Type: Behavioral
Name: Questionnaires Type: Behavioral
Name: Email Coaching Type: Behavioral
Overall Status
Recruiting
Summary
High-Risk Families:

The goal of this research study is to learn more about an exercise and weight management program for high-risk families affected by breast and ovarian cancer. Different kinds of interventions will be used and compared to learn which are more helpful.

MD Anderson Employees:

The goal of this research study is to learn more about an exercise and weight management program for MD Anderson employees. Different kinds of interventions will be used and compared to learn which are more helpful.
Detailed Description
High Risk Families:

Study Procedures:

If you are found to be eligible to take part in this study, you will be mailed an accelerometer, measuring tape, instructions for wearing the accelerometer for 7 days and measuring hip and waist circumference, and a return mailer for these items. You will also be mailed a FitBit (a small device you will wear that will track your activity), access to the FitBit website, a FitBit account with which you can view your information and record diet and non-walking/running physical activity, a guidebook, and brochures.

You will be randomly assigned (as in a roll of dice) to 1 of 16 study groups. The study staff will call you to explain which group you are in and which interventions you will receive. The 16 groups will each receive a different combination of each of the 4 following factors:

1. Weekly telephone coaching or email coaching

2. Text messages or no text messages

3. Social networking or no social networking

4. 4-7 days/week self-monitoring or one day/week self-monitoring.

For example, 1 group will receive weekly telephone coaching, text messages, social networking, and daily self-monitoring; and 1 group will receive email coaching, no text messages, no social networking, and one day/week self-monitoring. The other 14 groups will receive a combination of each of the 2 different kinds of the 4 factors.

You will receive your interventions for 16 weeks.

If you receive telephone coaching, you will have 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing. These calls will be based on your FitBit data. The coach will discuss your fitness goals with you, as well as any difficulty you may be having with meeting your goals.

If you receive email coaching, you will be called during the first week to discuss the interventions. This call will last about 10-15 minutes. You will then receive 1 email each week in Weeks 2-16 in which the coach will provide feedback about your goals and ask 1-2 questions similar to what the telephone coach would ask. If you respond to the coach, the conversation will continue until you make no further response.

If you receive text messaging, you will receive 8-12 messages each week that will contain support and/or information about how to meet your fitness goals.

If you receive social networking, you will be invited to use an online forum to discuss your fitness goals with other participants in the study who are receiving social networking.

At the beginning of the study, you will be mailed a Fitbit, as well as instructions on how to use it. If you are in a 4-7 days/week self-monitoring group, you will enter additional information about your diet and activity 4-7 days per week. If you are in a one day/week self-monitoring group, you will do this 1 day each week.

Study Questionnaires:

You will complete online questionnaires at the beginning of the study as well as 8 and 16 weeks after that. The online questionnaires will be sent to you by email, text message, and/or a letter with a link to the survey. If you prefer to complete a paper questionnaire, you may request this when you start the study and the study staff will provide you a paper questionnaire by mail with a self-addressed stamped envelope.

In the questionnaires, you will record your self-measured height, weight, and waist and hip measurements. The questionnaires will also ask you about your demographic information (such as your age), medical history, body composition, physical activity, diet, readiness to change, and your general health. These questionnaires should take about 30-45 minutes to complete.

Length of Study:

Your study participation will be over after you complete the questionnaire at Week 16. Your study participation may be stopped early if you become injured, if you become ineligible (for example, if you need to have treatment), or if the study staff thinks it is in your best interest.

This is an investigational study.

Up to 32 families will take part in this study. All will be enrolled at MD Anderson.

MD Anderson Employees:

Study Procedures:

If you are found to be eligible to take part in this study, the study staff will schedule a time, date, and location at MD Anderson for you to receive an accelerometer. The study staff will also provide you with instructions for wearing the accelerometer for 7 days before your first visit.

You will have 2 study visits at MD Anderson: at the beginning of the study and at the 4 month time point. At these visits, study staff will measure your height, weight, and waist and hip circumference. You will also return your accelerometer in person at that time. These study visits will last no longer than one hour.

At the first visit, you will receive a FitBit (a small device you will wear that will track your activity), access to the FitBit website, a FitBit account with which you can view your information and record diet and non-walking/running physical activity, a guidebook, and brochures.

You will also be randomly assigned (as in a roll of dice) to 1 of 16 study groups. The study staff will call you to explain which group you are in and which interventions you will receive. The 16 groups will each receive a different combination of each of the 4 following factors:

1. Weekly telephone coaching or email coaching

2. Text messages or no text messages

3. Social networking or no social networking

4. 4-7 days/week self-monitoring or one day/week self-monitoring.

For example, 1 group will receive weekly telephone coaching, text messages, social networking, and daily self-monitoring; and 1 group will receive email coaching, no text messages, no social networking, and one day/week self-monitoring. The other 14 groups will receive a combination of each of the 2 different kinds of the 4 factors.

You will receive your specific interventions for 16 weeks.

If you receive telephone coaching, you will have 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing. These calls will be based on your Fitbit data. The coach will discuss your fitness goals with you, as well as any difficulty you may be having with meeting your goals.

If you receive email coaching, you will be called during the first week to discuss the procedure. This call will last about 10-15 minutes. You will then receive 1 email each week in weeks 2-16 in which the coach will provide feedback about your goals and ask 1-2 questions similar to what the telephone coach would ask. If you respond to the coach, the conversation will continue until you make no further response.

If you receive text messaging, you will receive 8-12 messages each week that will contain support and/or information about how to meet your fitness goals.

If you receive social networking, you will be invited to use an online forum to discuss your fitness goals with other participants in the study who are receiving social networking.

At the beginning of the study, you will be given the Fitbit, as well as instructions on how to use it. If you are in a 4-7 days/week self-monitoring group, you will enter additional information about your diet and activity 4-7 days per week. If you are in a one day/week self-monitoring group, you will do this 1 day each week.

Study Questionnaires:

You will complete online questionnaires at the beginning of the study as well as 8 and 16 weeks after that. The online questionnaires will be sent to you by email, text message, and/or a letter with a link to the survey. If you prefer to complete a paper questionnaire, you may request this when you start the study and the study staff will provide you a paper questionnaire by mail with a self-addressed stamped envelope.

In the questionnaires, you will record your self-measured height, weight, and waist and hip measurements. The questionnaires will also ask you about your demographic information (such as your age), medical history, body composition, physical activity, diet, readiness to change, and your general health. These questionnaires should take about 30-45 minutes to complete.

Length of Study:

Your study participation will be over after you complete the questionnaire at the 4 month time point. Your study participation may be stopped early if you become injured, if you become ineligible (for example, if you need to have treatment), or if the study staff thinks it is in your best interest.

This is an investigational study.

Up to 48 participants will take part in this study. All will be enrolled at MD Anderson.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Pilot 1 and 2: BMI of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR <5 servings of fruit and vegetables per day

2. Pilot 1 and Pilot 2: Capable of participating in moderate-vigorous unsupervised exercise

3. Pilot 1 and Pilot 2: Have a cellular telephone and are able and willing to send and receive text messages

4. Pilot 1 and Pilot 2: 18 years old or older

5. Pilot 1 and Pilot 2: Able to read and write English

6. Pilot 1 and 2: Have access to internet

7. Pilot 2 (patient): BRCA (BReast CAncer) positive breast and/or ovarian cancer survivors of stage I through III, at least 3 months post-surgery and not currently receiving radiation therapy or cytotoxic chemotherapy

8. Pilot 2 (family member): Female and male biological and non-biological family members of BRCA-positive survivors

Exclusion Criteria:

1. Pilot 1 and Pilot 2: Unable to walk without crutches, walker, cane, or other assistive device

2. Women who are pregnant (by self-report)
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
September 2014
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page