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

NCT04200482 | Completed Phase 2

• 3 other identifiers: RG1006427NCI-2019-0764310335
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Breast Cancer Survivors; Diet; eHealth; Nutrition; Physical Activity; Breast

Outcome Measures

Primary Outcomes (6)

• Accrual rate

  Accrual rate will be measured by number of participants randomized during each month of study accrual.

  At 6 months

• Adherence: Session(s) Attendance

  Adherence will be measured by number of online session(s) attended per participant.

  At 6 months

• Adherence: Responsiveness to eHealth communication

  Adherence will be measured by the number of responses to text messages per participant.

  At 6 months

• Biospecimen collection rate

  Biospecimen collection rate will be assessed based on number of biospecimens collected.

  At 6 months

• Retention

  Retention will be measured by the number of completed study assessments per participants.

  At 6 months

• Acceptability: Questions during exit interview

  Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire.

  At 6 months

Secondary Outcomes (4)

• Change in daily servings of fruits and vegetables per day

  Baseline to 6 months

• Change in minutes per week of moderate-to-vigorous physical activity

  Baseline to 6 months

• Change in systemic inflammation

  Baseline to 6 months

• Change in gut barrier permeability

  Baseline to 6 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

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

EXPERIMENTAL

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

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

Interventions

One Diet and Physical Activity Session BEHAVIORAL

Attend 1 remote diet and physical activity session

Also known as: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

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

Electronic (e) Health (eHealth) Communication Intervention OTHER

Receive eHealth communication intervention

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

Twelve Diet and Physical Activity Group Sessions BEHAVIORAL

Attend 12 remote diet and physical activity sessions in 6 months

Also known as: Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

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

Questionnaire Administration OTHER

Ancillary studies

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• Ueland K, Sanchez SC, Rillamas-Sun E, Shen H, Schattenkerk L, Garcia G, VanDoren M, Myers SA, Santiago-Torres M, Di C, Dey N, Guthrie KA, Yung R, Davidson NE, Greenlee H. A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106993. doi: 10.1016/j.cct.2022.106993. Epub 2022 Nov 3.

  PMID: 36336249 DERIVED

• Rillamas-Sun E, Schattenkerk L, Cobos S, Ueland K, Gaffney AO, Greenlee H. Characteristics of Users of the Cook for Your Life Website, an Online Nutrition Resource for Persons Affected by Cancer: Descriptive Study. JMIR Cancer. 2022 Jul 5;8(3):e37212. doi: 10.2196/37212.

  PMID: 35788100 DERIVED

MeSH Terms

Conditions

Breast Carcinoma In Situ; Motor Activity

Interventions

Behavior Therapy; Health; Telemedicine

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nancy E Davidson

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Heather Greenlee

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 16, 2019
• Study Start: February 21, 2020
• Primary Completion: August 24, 2021
• Study Completion: October 28, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)