Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

Terminated

• Conditions: Breast Neoplasms; Body Weight Changes

• Registration Number: NCT02887196
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Study Start: 2016-12
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived attitudes towards lifestyle interventions	9 months	Qualitative data collected via semi-structured interview

Secondary Outcome Measures

Name	Time	Method
Diet	9 months	24 hour recall (ASA24) to assess food intake changes throughout treatment
Physical Activity	9 months	Wrist worn Actigraph accelerometer to assess activity changes throughout treatment
Body Weight	9 months	Body weight change throughout treatment

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States