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Completed

NCT Number: NCT02681965

A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors

Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).

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Key information

Conditions

Breast Cancer Survivorship Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.

The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.

Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Overweight individuals (BMI >= 25.0 kg/m2)
  • Breast cancer survivors who have completed chemotherapy and/or radiation therapy
  • Stage 0-III
  • The ability to be physically able to exercise (e.g. walk at a moderate pace)
  • Agree to random assignment to either group
  • Give informed consent to participate in all study activities
  • Accessible by telephone
  • Able read and communicate in English

Exclusion criteria

  • Pregnant or intending to become pregnant in the next year
  • Recent (past 6 months) stroke or myocardial infarction
  • Severe uncontrolled mental illness

Treatment and study plan

LEAN book/videos

Behavioral

The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.

Primary outcomes

  1. Body weight (kg)

    Time frame: 6 Months

    A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).

Secondary outcomes

  1. Body weight (kg)

    Time frame: Baseline

    A standard digital scale will be used to measure participants at baseline. Body weight will be collected in kilograms (kg).

  2. Body weight (kg)

    Time frame: 12 Months

    A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).

  3. Quality of Life (QOL)

    Time frame: Baseline

    QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment.

  4. Quality of Life (QOL)

    Time frame: 6 months

    QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment.

  5. Dietary Intake

    Time frame: Baseline

    The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.

  6. Dietary Intake

    Time frame: 6 months

    The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.

  7. Dietary Intake

    Time frame: 12 months

    The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.

  8. Physical Activity (Moderate)

    Time frame: Baseline

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

  9. Physical Activity (Moderate)

    Time frame: 6 months

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

  10. Physical Activity (Moderate)

    Time frame: 12 months

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

  11. Physical Activity (Vigorous)

    Time frame: Baseline

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

  12. Physical Activity (Vigorous)

    Time frame: 6 months

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

  13. Physical Activity (Vigorous)

    Time frame: 12 months

    Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.

Acronym: LEAN3

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2016
Registry last updated
Jun 29, 2018

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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