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

Primary Purpose

Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

One Diet and Physical Activity Session

Electronic (e) Health (eHealth) Communication Intervention

Twelve Diet and Physical Activity Group Sessions

Questionnaire Administration

Quality-of-Life Assessment

About this trial

This is an interventional supportive care trial for Anatomic Stage 0 Breast Cancer AJCC v8 focused on measuring Breast Cancer Survivors, Diet, eHealth, Nutrition, Physical Activity, Breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

Accrual rate

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

Adherence: Session(s) Attendance

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

Adherence: Responsiveness to eHealth communication

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

Biospecimen collection rate

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

Retention

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

Acceptability: Questions during exit interview

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

Secondary Outcome Measures

Change in daily servings of fruits and vegetables per day

Will be assessed by 24-hour dietary recalls.

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

Will be assessed by 7-day accelerometer data.

Change in systemic inflammation

Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.

Change in gut barrier permeability

Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.

Full Information

NCT ID

NCT04200482

First Posted

December 10, 2019

Last Updated

November 2, 2021

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Breast Cancer Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04200482

Brief Title

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

Official Title

Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

February 21, 2020 (Actual)

Primary Completion Date

August 24, 2021 (Actual)

Study Completion Date

October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

One Diet and Physical Activity Session

Other Intervention Name(s)

Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

Intervention Description

Attend 1 remote diet and physical activity session

Intervention Type

Other

Intervention Name(s)

Electronic (e) Health (eHealth) Communication Intervention

Intervention Description

Receive eHealth communication intervention

Intervention Type

Behavioral

Intervention Name(s)

Twelve Diet and Physical Activity Group Sessions

Other Intervention Name(s)

Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions, Behavioral Treatments

Intervention Description

Attend 12 remote diet and physical activity sessions in 6 months

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Accrual rate

Description

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

Time Frame

At 6 months

Title

Adherence: Session(s) Attendance

Description

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

Time Frame

At 6 months

Title

Adherence: Responsiveness to eHealth communication

Description

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

Time Frame

At 6 months

Title

Biospecimen collection rate

Description

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

Time Frame

At 6 months

Title

Retention

Description

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

Time Frame

At 6 months

Title

Acceptability: Questions during exit interview

Description

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

Time Frame

At 6 months

Secondary Outcome Measure Information:

Title

Change in daily servings of fruits and vegetables per day

Description

Will be assessed by 24-hour dietary recalls.

Time Frame

Baseline to 6 months

Title

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

Description

Will be assessed by 7-day accelerometer data.

Time Frame

Baseline to 6 months

Title

Change in systemic inflammation

Description

Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein.

Time Frame

Baseline to 6 months

Title

Change in gut barrier permeability

Description

Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein.

Time Frame

Baseline to 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy E Davidson

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heather Greenlee

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36336249

Citation

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.

Results Reference

derived

PubMed Identifier

35788100

Citation

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.

Results Reference

derived

Learn more about this trial

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

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