Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy

NCT ID: NCT01941784

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-25
• Study Completion Date: 2017-04-12

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (health education program)

See Detailed Description.

Group Type: EXPERIMENTAL

educational intervention

Intervention Type: OTHER

Undergo health education program

counseling intervention

Intervention Type: OTHER

Undergo health education program

telephone-based intervention

Intervention Type: BEHAVIORAL

Receive follow-up phone calls

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

Interventions

educational intervention

Undergo health education program

Intervention Type: OTHER

counseling intervention

Undergo health education program

Intervention Type: OTHER

telephone-based intervention

Receive follow-up phone calls

Intervention Type: BEHAVIORAL

questionnaire administration

Ancillary studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

Other Intervention Names

intervention, educational; counseling and communications studies; quality of life assessment

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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon Mihalko

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2013-01742

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 97513

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00025131

Identifier Type: -

Identifier Source: org_study_id