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Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT04200482

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

A Phase 2 study testing One Diet and Physical Activity Session, Electronic (e) Health (eHealth) Communication Intervention and Twelve Diet and Physical Activity Group Sessions in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
One Diet and Physical Activity Session, Electronic (e) Health (eHealth) Communication Intervention and Twelve Diet and Physical Activity Group Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
21 Feb 2020to 28 Oct 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
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
Keywords
Breast Cancer Survivors, Diet, eHealth, Nutrition, Physical Activity, Breast
Medical subject headings
Breast Carcinoma In Situ, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One Diet and Physical Activity SessionBehavioural

    Also called Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions

    Attend 1 remote diet and physical activity session

  • Electronic (e) Health (eHealth) Communication InterventionOther

    Receive eHealth communication intervention

  • Twelve Diet and Physical Activity Group SessionsBehavioural

    Also called Behavior or Lifestyle Modifications, behavior modification, Behavior Conditioning Therapy, Behavioral Interventions

    Attend 12 remote diet and physical activity sessions in 6 months

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT04200482
Study groupRoleWhat they receive
Arm A (low dose nutrition and PA class, eHealth intervention)Active comparatorParticipants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Receives: 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)ExperimentalParticipants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
Receives: Other: Electronic (e) Health (eHealth) Communication Intervention; Behavioral: Twelve Diet and Physical Activity Group Sessions; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual rate

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

    Measured: At 6 months

  2. Adherence: Session(s) Attendance

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

    Measured: At 6 months

  3. Adherence: Responsiveness to eHealth communication

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

    Measured: At 6 months

  4. Biospecimen collection rate

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

    Measured: At 6 months

  5. Retention

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

    Measured: At 6 months

  6. Acceptability: Questions during exit interview

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

    Measured: At 6 months

Secondary outcomes (4)

  1. Change in daily servings of fruits and vegetables per day

    Will be assessed by 24-hour dietary recalls.

    Measured: Baseline to 6 months

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

    Will be assessed by 7-day accelerometer data.

    Measured: Baseline to 6 months

  3. Change in systemic inflammation

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

    Measured: Baseline to 6 months

  4. Change in gut barrier permeability

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

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start21 Feb 2020
  3. Primary completion24 Aug 2021
  4. Study completion28 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200482
Sponsor's protocol ID
RG1006427
Other IDs
NCI-2019-07643, 10335
Status last verified
Nov 2021
First submitted
10 Dec 2019
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36336249

  • 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.

    PubMed 35788100

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing One Diet and Physical Activity Session, Electronic (e) Health (eHealth) Communication Intervention and Twelve Diet and Physical Activity Group Sessions in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual rate (time frame: At 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04200482, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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