Clinical trial NCT02887196: Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment
Official title: Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Body Weight Changes
Keywords: Breast Cancer
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community hospitals and physician offices in the Baton Rouge, LA area

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.

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

Primary outcomes:
measure: Perceived attitudes towards lifestyle interventions
timeFrame: 9 months
Secondary outcomes:
measure: Diet
timeFrame: 9 months
measure: Physical Activity
timeFrame: 9 months
measure: Body Weight
timeFrame: 9 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Anne Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: