NCT03751449

Brief Summary

This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2021

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2.1 years

First QC Date

November 14, 2018

Last Update Submit

June 3, 2022

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Cancer SurvivorInactivityObesityOverweightPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

  • Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.

    Will measure the effect on physical function (6-minute walk test). Activity levels for all participants will be collected using the Fitbit applications and/or a weekly activity log.

    Up to 2 years

  • Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment)

    Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on quality of life.

    Up to 2 years

Secondary Outcomes (5)

  • Diet quality as assessed by the ASA24 website

    Up to 2 years

  • Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Up to 2 years

  • Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention

    Up to 2 years

  • motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)

    Up to 2 years

  • Centers for Epidemiologic Studies Depression Scale (CESD-R)

    Up to 2 years

Study Arms (2)

Group I (active treatment)

EXPERIMENTAL

Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.

Other: Educational InterventionBehavioral: Exercise InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Group II (waitlist)

ACTIVE COMPARATOR

Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.

Other: Educational InterventionBehavioral: Exercise InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Educational InterventionOTHER

Receive nutrition education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Group I (active treatment)Group II (waitlist)
Exercise InterventionBEHAVIORAL

Complete home-based aerobic and resistance exercise program

Group I (active treatment)Group II (waitlist)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Group I (active treatment)Group II (waitlist)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (active treatment)Group II (waitlist)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men or women with a history of breast cancer who have completed treatment \>=3 months ago (not including hormonal therapy, Zometa, or other non-chemotherapy/radiation cancer treatment at the discretion of the principal investigator)
  • Physically inactive, defined as not meeting 150 minutes or 2 hours and 30 minutes a week of vigorous-intensity exercise
  • Overweight or obese, defined as having a body mass index (BMI) between 26 kg/m\^2 and 42 kg/m\^2, inclusive
  • Meeting criteria for participation in low to moderate risk exercise based on the American College of Sports and Medicine (ACSM) guideline
  • Providing informed consent indicating understanding the investigational nature of this study by signing an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedures

You may not qualify if:

  • Metastatic breast cancer
  • Orthopedic or neuromuscular disorders that preclude participation in exercise
  • Any history of myocardial infarction (MI), angina pectoris, or congestive heart failure
  • High risk for moderate exercise based on ACSM risk classification
  • Pregnant or nursing
  • Unwilling or unable to follow protocol requirements
  • Any condition which - in the investigator?s opinion - deems the participant an unsuitable candidate to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorObesityOverweight

Interventions

Early Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Tracey O'Connor

    Roswell Park Cancer Institute

    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
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 23, 2018

Study Start

March 25, 2019

Primary Completion

May 1, 2021

Study Completion

May 21, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

US(1)