Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 2

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: One Diet and Physical Activity Session; Other: Electronic (e) Health (eHealth) Communication Intervention; Behavioral: Twelve Diet and Physical Activity Group Sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT04200482

RG1006427

10335 (Other Identifier)

NCI-2019-07643 (Registry Identifier)

Details and patient eligibility

About

The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.

Full description

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment
• No evidence of recurrent or metastatic disease
• No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 8%
• No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care
• At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
• Access to phone for study contacts
• Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website)
• Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months
• Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample
• Willing and able to complete all study activities for 6 months after randomization
• Participants must consume < 5 servings of fruits and vegetables per day and/or engage in < 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status.
• Signed physician approval for diet change and physical activity
• Able to understand and willing to sign written informed electronic (e) consent in English

Exclusion criteria

• Participants must not be active smokers within the past 30 days.
• Women must not be pregnant at time of enrollment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Arm A (low dose nutrition and PA class, eHealth intervention)

Active Comparator group

Description:

Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

Treatment:

Other: Questionnaire Administration

Other: Electronic (e) Health (eHealth) Communication Intervention

Behavioral: One Diet and Physical Activity Session

Other: Quality-of-Life Assessment

Arm B (high dose nutrition and PA class, eHealth intervention)

Experimental group

Description:

Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

Treatment:

Other: Questionnaire Administration

Behavioral: Twelve Diet and Physical Activity Group Sessions

Other: Electronic (e) Health (eHealth) Communication Intervention

Other: Quality-of-Life Assessment