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Completed

NCT Number: NCT01217216

Cancer Survival Through Weight Loss and Exercise

To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.

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Key information

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women between the ages of 30 and 75.
  • Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
  • BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
  • Not involved in regular physical activity or weight loss management programs.
  • Stage I, II or IIIa breast cancer with good prognosis.

Exclusion criteria

  • Presence of any co-morbidities including cardiovascular disease or diabetes
  • Fasting triglycerides > 500 mg/dl.
  • Consume more than 14 alcoholic beverages per week.
  • A history of drug abuse, or excess alcohol consumption (40g/day)6.
  • Currently dieting or engaging in any activity with the goal of losing weight.
  • Significant intentional weight loss in the past year (> 50 lbs in the past year) or current use of weight loss medications.
  • History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
  • Pregnant or plan on becoming pregnant in the next 12 months.
  • Factors that may limit adherence to intervention or affect conduct of the trial.
  • Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
  • Failure to complete run-in and baseline testing.
  • Lack support from health care provider or family members.
  • Other temporary intervening event, such as sick spouse, bereavement, or recent move.
  • Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
  • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
  • Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.

Treatment and study plan

Group-Based Intervention

Behavioral

compared effects of a group-based intervention on weight loss and physical activity.

Telephone-Based Intervention

Behavioral

compared telephone-based intervention to weight loss and physical activity.

Primary outcomes

  1. Weight loss

    Time frame: 1 year

    To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer.

Secondary outcomes

  1. Feasibility of recruiting breast cancer survivors

    Time frame: 1 year

    To examine the feasibility of recruiting, administering, and maintaining interventions in a small sample of women with a history of breast cancer in a community health setting for pilot data.

  2. Examination of health outcomes, breast cancer reoccurrence, and mortality.

    Time frame: 1 year

    To examine health outcomes, cancer reoccurrence, and mortality in women with a history of breast cancer within the 12 month period via adverse events. Additional procedures include resting ECG, waist circumference, weight, and blood work.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Cancer Survival Through Weight Loss and Exercise (CASTLE)

Acronym: CASTLE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2010
Registry last updated
Sep 15, 2022

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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