Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
NCT ID: NCT02194387
Last Updated: 2025-09-08
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
337 participants
INTERVENTIONAL
2014-09-17
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Supportive care (energy balance interventions)
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.
Dietary Intervention
Record dietary intake 4-7 days per week
Dietary Intervention
Record dietary intake 1 day per week
Internet-Based Intervention
Receive email coaching
Internet-Based Intervention
Participate in social networking
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive telephone coaching
Telephone-Based Intervention
Receive text messages
Interventions
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Dietary Intervention
Record dietary intake 4-7 days per week
Dietary Intervention
Record dietary intake 1 day per week
Internet-Based Intervention
Receive email coaching
Internet-Based Intervention
Participate in social networking
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive telephone coaching
Telephone-Based Intervention
Receive text messages
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Karen M Basen-Engquist
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Crane JC, Gordon MJ, Basen-Engquist K, Ferrajoli A, Markofski MM, Lee CY, Fares S, Simpson RJ, LaVoy EC. Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Eur J Haematol. 2023 Jun;110(6):732-742. doi: 10.1111/ejh.13958. Epub 2023 Mar 31.
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2015-00095
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0230
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0230
Identifier Type: -
Identifier Source: org_study_id
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