NCT03243786

Brief Summary

The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

February 16, 2017

Last Update Submit

November 18, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm

    6 months

Secondary Outcomes (28)

  • Percent of participant retention thoughout the 12-week intervention through the six month follow-up

    6 months

  • The percent of eligible patient who choose to take part in the study

    6 months

  • Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm

    6 months

  • Changes in lean soft tissue over the study period associated with intervention and activity

    6 months

  • Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity

    6 months

  • +23 more secondary outcomes

Study Arms (2)

12-week "Stay on Track" intervention

ACTIVE COMPARATOR

The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging

Behavioral: Lifestyle- Supportive Care

12-week self-guided control

ACTIVE COMPARATOR

The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months

Behavioral: Lifestyle- Supportive Care

Interventions

Lifestyle- Supportive CareBEHAVIORAL

The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy

12-week "Stay on Track" intervention12-week self-guided control

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Breast Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years of age;
  • confirmed primary non-metastatic breast adenocarcinoma;
  • planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
  • planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
  • Have a Karnovsky Performance Score of 70 or above (see Appendix)
  • Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
  • have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
  • understand and speak English;
  • physically able to engage in the intervention;
  • accepting of randomization (Note that anti-estrogen therapy is allowed.)

You may not qualify if:

  • Patients who have metastatic disease;
  • Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
  • Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
  • Patients who have received chemotherapy for their breast cancer.
  • Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carmen Bergom, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Radiation Oncology

Study Record Dates

First Submitted

February 16, 2017

First Posted

August 9, 2017

Study Start

April 12, 2017

Primary Completion

September 1, 2018

Study Completion

October 31, 2018

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)