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Anatomic Stage I Breast Cancer AJCC v8NCT03751449

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

A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Educational Intervention, Exercise Intervention and Quality-of-Life Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
25 Mar 2019to 21 May 2021
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Educational Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Sedentary Behavior, Obesity, Overweight

What participants receive

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

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive nutrition education

  • Exercise InterventionBehavioural

    Complete home-based aerobic and resistance exercise program

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03751449
Study groupRoleWhat they receive
Group I (active treatment)ExperimentalParticipants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.
Receives: Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (waitlist)Active comparatorParticipants 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.
Receives: Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Diet quality as assessed by the ASA24 website

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

    Measured: Up to 2 years

  2. Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: Up to 2 years

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

    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

    Measured: Up to 2 years

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

    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)

    Measured: Up to 2 years

  5. Centers for Epidemiologic Studies Depression Scale (CESD-R)

    A self reported 20 item scale that measures depressive symptoms. A higher score denotes greater depressive symptoms.

    Measured: Up to 2 years

Timeline

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

  1. First posted23 Nov 2018
  2. Study start25 Mar 2019
  3. Primary completion1 May 2021
  4. Study completion21 May 2021

Why it stopped: lack of resources

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03751449
Sponsor's protocol ID
i 67518
Other IDs
NCI-2018-01704, i 67518
Status last verified
Jun 2022
First submitted
14 Nov 2018
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Roswell Park Cancer Institute 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Jun 2022. 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.

Are results available for this study?

The study was stopped early (reason given: lack of resources). Results are not available in the source record.

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?

Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log. (time frame: Up to 2 years). The study lists 2 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 NCT03751449.

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 6 Jun 2022.

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