Clinical trial NCT01941784: Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
Official title: Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-13
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants.

II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored.

III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial.

IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit.

OUTLINE:

Participants undergo four 30-60 minute health education sessions and 3 follow-up phone sessions with an interventionist trained in behavioral science, physical activity and nutrition, and positive psychology over 12 months.

EDUCATION SESSION I: Participants receive information from the interventionist concerning healthy diet choices and exercise and begin to keep a food log.

EDUCATION SESSION II: Interventionists review information from session I and patient food logs. Participants receive recommendations for exercise and set activity goals.

EDUCATION SESSION III: Participants receive information on how to determine portion sizes and the importance of strength training and building lean muscle mass.

EDUCATION SESSION IV: Interventionists review information from the previous 3 sessions and discuss the importance of planning and goal setting with participants. The interventionist also discusses physical and mental barriers to exercise.

After completion of the education sessions, patients receive 3 phone calls at times convenient to the patient to answer questions about information learned in previous educational sessions.

After completion of study, participants are followed up for 12 months.

Eligibility criteria: Inclusion Criteria:

* Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
* 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) \> 20
* Treating physician approval to participate in study
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Diagnosis of recurrent breast cancer
* Women who are already participating in a formal or medically prescribed weight management program
* Women who have already completed more than two rounds of chemotherapy
* Women who are pregnant or nursing

Primary outcomes:
measure: Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
timeFrame: Baseline
Secondary outcomes:
measure: Effect of the intervention on body composition
timeFrame: Up to 52 weeks
measure: Effect of the intervention on self-efficacy
timeFrame: Up to 52 weeks
measure: Effect of the intervention on perceived stress
timeFrame: Up to 52 weeks
measure: Effect of the intervention on fatigue
timeFrame: Up to 52 weeks
measure: Effect of the intervention on 6 minute walk distance
timeFrame: Up to 52 weeks
measure: Effect of the intervention on fruit, vegetable, and fat intake
timeFrame: Up to 52 weeks
measure: Effect of the intervention on physical activity participation
timeFrame: Up to 52 weeks
measure: Effect of the intervention on health-related quality of life
timeFrame: Up to 52 weeks
measure: Sample size for future larger trials
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Shannon Mihalko
role: PRINCIPAL_INVESTIGATOR
References: