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Completed

NCT Number: NCT01941784

Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy

This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.

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Key information

Conditions

Stage IA Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

PRIMARY OBJECTIVES:

I. To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants.

II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored.

III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial.

IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit.

OUTLINE:

Participants undergo four 30-60 minute health education sessions and 3 follow-up phone sessions with an interventionist trained in behavioral science, physical activity and nutrition, and positive psychology over 12 months.

EDUCATION SESSION I: Participants receive information from the interventionist concerning healthy diet choices and exercise and begin to keep a food log.

EDUCATION SESSION II: Interventionists review information from session I and patient food logs. Participants receive recommendations for exercise and set activity goals.

EDUCATION SESSION III: Participants receive information on how to determine portion sizes and the importance of strength training and building lean muscle mass.

EDUCATION SESSION IV: Interventionists review information from the previous 3 sessions and discuss the importance of planning and goal setting with participants. The interventionist also discusses physical and mental barriers to exercise.

After completion of the education sessions, patients receive 3 phone calls at times convenient to the patient to answer questions about information learned in previous educational sessions.

After completion of study, participants are followed up for 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
  • 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) > 20
  • Treating physician approval to participate in study
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion criteria

  • Diagnosis of recurrent breast cancer
  • Women who are already participating in a formal or medically prescribed weight management program
  • Women who have already completed more than two rounds of chemotherapy
  • Women who are pregnant or nursing

Treatment and study plan

Educational Intervention

Other

Undergo health education program

Other names: intervention, educational

counseling intervention

Other

Undergo health education program

Other names: counseling and communications studies

Telephone-Based Intervention

Behavioral

Receive follow-up phone calls

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate

    Time frame: Baseline

    Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.

Secondary outcomes

  1. Effect of the intervention on body composition

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure analysis of covariance (ANCOVAs) to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  2. Effect of the intervention on self-efficacy

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  3. Effect of the intervention on perceived stress

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  4. Effect of the intervention on fatigue

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  5. Effect of the intervention on 6 minute walk distance

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  6. Effect of the intervention on fruit, vegetable, and fat intake

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  7. Effect of the intervention on physical activity participation

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  8. Effect of the intervention on health-related quality of life

    Time frame: Up to 52 weeks

    Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.

  9. Sample size for future larger trials

    Time frame: Up to 52 weeks

    Data from outcomes 1 and 2 along with qualitative data, will allow researchers to refine the protocol accordingly.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2013
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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