Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors

June 3, 2022 updated by: Roswell Park Cancer Institute

Exercise and Nutrition Intervention in Older Breast Cancer Survivors - The WIN CA Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention in overweight or obese, sedentary, older (65 years and above) breast cancer survivors on physical function (6-minute walk test) and quality of life compared to standard of care.

SECONDARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality, sleep, anxiety, depression, source of motivation for exercise, and immune function in overweight or obese, sedentary, older (65 years and above) breast cancer survivors compared to standard of care.

EXPLORATORY OBJECTIVES:

I. To determine how body composition (dual X-ray absorptiometry [DEXA]) and weight maintenance are affected by a 12-week aerobic and resistance exercise training program among older (65 years and above), sedentary, overweight and obese breast cancer survivors.

II. To compare differences in the above outcomes among older (65 years and above), sedentary, overweight and obese breast cancer survivors who completed a home-based aerobic and resistance exercise training program versus those who did not receive the intervention, standard of care.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.

GROUP II (WAITLIST): 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (active treatment)
Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive nutrition education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Behavioral: Exercise Intervention
Complete home-based aerobic and resistance exercise program
Active Comparator: Group II (waitlist)
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive nutrition education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Behavioral: Exercise Intervention
Complete home-based aerobic and resistance exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet quality as assessed by the ASA24 website
Time Frame: Up to 2 years
Will measure the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality.
Up to 2 years
Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Up to 2 years
The PSQI measures the quality and pattern of sleeps in adults. There are 19 items. Each item is weighted on a 0-3 interval scale.
Up to 2 years
Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention
Time Frame: Up to 2 years
Will measure anxiety as assessed by the State Trait Anxiety Inventory (STAI-Y1)e STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety
Up to 2 years
motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)
Time Frame: Up to 2 years
A 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me)
Up to 2 years
Centers for Epidemiologic Studies Depression Scale (CESD-R)
Time Frame: Up to 2 years
A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Tracey O'Connor, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 21, 2021

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • i 67518 (Other Identifier: Roswell Park Cancer Institute)
  • NCI-2018-01704 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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