Cancer Survival Through Weight Loss and Exercise

NCT01217216 | Completed DMC

• 1 other identifier: PBRC 28036
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Survivors

Keywords

Breast Cancer; Weight loss; Group Intervention; Telephone Intervention

Outcome Measures

Primary Outcomes (1)

• Weight loss

  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.

  1 year

Secondary Outcomes (2)

• Feasibility of recruiting breast cancer survivors

  1 year

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

  1 year

Study Arms (2)

Group-based Intervention

ACTIVE COMPARATOR

We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.

Behavioral: Group-based Intervention

Telephone-based Intervention

ACTIVE COMPARATOR

We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.

Behavioral: Telephone-based Intervention

Interventions

Group-based Intervention BEHAVIORAL

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

Group-based Intervention

Telephone-based Intervention BEHAVIORAL

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

Telephone-based Intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5.

  PMID: 22535636 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy S Church, MD, MPH, PhD

  Pennington Biomedica Research Center

  PRINCIPAL INVESTIGATOR

• Donna H Ryan, MD

  Pennington Biomedical Research Center

  STUDY DIRECTOR

• Conrad P Earnest, PhD

  Pennington Biomedical Research Center

  STUDY DIRECTOR

• Valerie H Myers, PhD

  Pennington Biomedical Research Center

  STUDY DIRECTOR

• Catherine M Champagne, PhD

  Pennington Biomedical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 8, 2010
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (1)