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Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

Primary Purpose

Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Dietary Intervention
Internet-Based Intervention
Internet-Based Intervention
Laboratory Biomarker Analysis
Questionnaire Administration
Telephone-Based Intervention
Telephone-Based Intervention
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Mass Index 25 or Greater

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day
  • PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
  • PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
  • PILOTS I, II AND III: Able to read and write English
  • PILOTS I, II AND III: Have access to internet
  • PILOT II: BRCA positive OR Lynch syndrome positive individuals
  • PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
  • PILOT III: CLL survivors
  • PILOT III: Has experienced fatigue within the past seven days

Exclusion Criteria:

  • PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
  • PILOTS I, II AND III: Women who are pregnant (by self-report)
  • PILOTS I, II AND III: Less than 3 months post-surgery
  • PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (energy balance interventions)

Arm Description

TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.

Outcomes

Primary Outcome Measures

Change in waist circumference (Pilot I)
Expressed as the mean difference.
Change in waist circumference (Pilot II)
Expressed as the mean difference.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2014
Last Updated
August 22, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02194387
Brief Title
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Official Title
Pilot Tests to Optimize the Delivery of Energy Balance Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2014 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
Detailed Description
PRIMARY OBJECTIVES: I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I) II. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive individuals and their family members. (Pilot II) III. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (chronic lymphocytic leukemia) patients. (Pilot III) SECONDARY OBJECTIVES: I. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot II) III. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot III) EXPLORATORY OBJECTIVES: I. To examine relationship between individual-level (e.g., distress) and family-level (e.g., shared mutation status) variables that are specific to high-risk families and the effectiveness of energy balance interventions. (Pilot II) OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups using a randomized factorial design. TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone application (app). After completion of study, patients are followed up at 4 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma, Cancer Survivor, Chronic Lymphocytic Leukemia, Fatigue, Health Status Unknown, Lynch Syndrome, Ovarian Carcinoma, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (energy balance interventions)
Arm Type
Experimental
Arm Description
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Record dietary intake 4-7 days per week
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Record dietary intake 1 day per week
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive email coaching
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Participate in social networking
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone coaching
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive text messages
Primary Outcome Measure Information:
Title
Change in waist circumference (Pilot I)
Description
Expressed as the mean difference.
Time Frame
Baseline to 4 months post-intervention
Title
Change in waist circumference (Pilot II)
Description
Expressed as the mean difference.
Time Frame
Baseline to 4 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages PILOTS I, II AND III: Able to read and write English PILOTS I, II AND III: Have access to internet PILOT II: BRCA positive OR Lynch syndrome positive individuals PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals PILOT III: CLL survivors PILOT III: Has experienced fatigue within the past seven days Exclusion Criteria: PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device PILOTS I, II AND III: Women who are pregnant (by self-report) PILOTS I, II AND III: Less than 3 months post-surgery PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Basen-Engquist
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

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