Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

Breast Neoplasms Clinical Trial

— CARE  

Official title:

Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02887196
• Other study ID #: PBRC 2016-050
• Status: Terminated
• Start date: December 2016
• Est. completion date: September 18, 2018

Study information

• Verified date: July 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 18, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived attitudes towards lifestyle interventions	Qualitative data collected via semi-structured interview	9 months
Secondary	Diet	24 hour recall (ASA24) to assess food intake changes throughout treatment	9 months
Secondary	Physical Activity	Wrist worn Actigraph accelerometer to assess activity changes throughout treatment	9 months
Secondary	Body Weight	Body weight change throughout treatment	9 months