Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

NCT ID: NCT02887196

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-09-18

Brief Summary

Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . The primary goal of this pilot study is to investigate the physical and behavioral changes that occur in patients receiving treatment for breast cancer.

Detailed Description

In this cross sectional, longitudinal, observational study, 25 women will be followed through their treatment for stage I-III breast cancer. The women will be asked to provide their opinions and desires for lifestyle intervention at four timepoints throughout treatment. In addition to qualitative data, basic clinical data will be collected (anthropometrics, vital signs, dietary intake, and physical activity). The primary goal of this pilot study is to investigate the anthropometric and behavioral changes that occur in patients undergoing adjuvant chemotherapy for breast cancer.

Aim 1: To better understand patients' attitudes toward and perceived barriers to nutrition and physical activity interventions during neoplastic treatment.

Hypothesis: Patients' reported attitudes, motivation, and perceived barriers will change throughout treatment.

Aim 2: To measure the physical and metabolic changes that occur throughout neoplastic treatment for breast cancer.

Hypothesis: Over 50% of the participants will gain body weight during treatment and metabolic parameters will trend with body weight change.

Conditions

Breast Neoplasms; Body Weight Changes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Female
• ≥18 years of age
• Diagnosed with stage I, II or III breast cancer with plans to undergo endocrine and/or chemotherapy treatment (radiation in combination with one or more of these therapies is acceptable)
• Willing to complete up to 4 clinic visits

Exclusion Criteria

• Have received neoadjuvant therapy for current diagnosis
• Currently receiving adjuvant chemotherapy or other adjuvant therapy that was initiated prior to study enrollment
• History of cancer and neoplastic treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Anne Gilmore

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Gilmore, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 2016-050

Identifier Type: -

Identifier Source: org_study_id