Stage IA Uterine Corpus CancerNCT02575872
Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors
A study testing Exercise Intervention in people with Stage IA Uterine Corpus Cancer and Stage IB Uterine Corpus Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2018
- 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent form signed and dated by the subject
- English and/or Spanish speaking
- History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment
- Overweight (body mass index [BMI] >= 30)
- Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
- Medically capable of performing moderate intensity exercise
Who cannot join
- Must not have engaged in a regular (> 3x/week, physical activity program in the last 6 months)
- Medical contraindication to exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.
SECONDARY OBJECTIVES:
- To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.
TERTIARY OBJECTIVES:
- To determine the effects of a 12-week behavior/exercise intervention for ethnically diverse endometrial cancer survivors on physical function and quality-of-life.
II. To determine the most important behavioral variables for predicting physical activity adherence.
III. To determine the most significant facilitators and barriers to adherence during the 12-week intervention.
IV. To compare the thematic differences between high-adherence and low-adherence participants and qualitatively assess the strengths and weaknesses of the 12-week intervention.
OUTLINE: Participants are randomized to 1 of 2 groups
GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.
GROUP II: Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.
After completion of study, participants are followed up at 12 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Participate in physical activity behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks. Receives: Behavioral: Exercise Intervention |
| wait-list for intervention | No intervention | Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
Data will be analyzed using Pearson Chi-square test.
Measured: 12 weeks
Secondary outcomes (12)
Barrier avoidance/coping, measured using 5 point Likert scales
Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders.
Measured: Up to 12 weeks
BMI
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Up to 12 weeks
Change in ability to perform activities of daily living, assessed with the YPAS
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Baseline to 12 weeks
Change in sedentary time, assessed with the YPAS
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Baseline to 12 weeks
Exercise efficacy, measured using 5 point Likert scales
Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders.
Measured: Up to 12 weeks
Fatigue, assessed by the FACT-Fatigue
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Up to 12 weeks
Outcome expectations, measured using 5 point Likert scales
Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders.
Measured: Up to 12 weeks
Physical function score
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Up to 12 weeks
Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Up to 12 weeks
Self-regulation, measured using 5 point Likert scales
Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders.
Measured: Up to 12 weeks
Social support, measured using 5 point Likert scales
Multiple logistic regression analysis will be used to examine the association of the Social Cognitive Theory behavior variables to physical activity, adjusting for potential confounders.
Measured: Up to 12 weeks
Waist circumference
Will be analyzed using student t-test. When the data are non-normal, investigators will use appropriate nonparametric tests.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IA Uterine Corpus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nicole Nevadunsky, Albert Einstein College of Medicine
- Investigators
- Nicole Nevadunsky, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575872
- Sponsor's protocol ID
- 2013-2167
- Other IDs
- NCI-2014-01510, 2013-2167, P30CA013330
- Status last verified
- Sep 2019
- First submitted
- 13 Oct 2015
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.
PubMed 36971688
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Comprehensive Physical Activity Behavioral Intervention on Underserved Diverse Obese Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT02575872
- Acronym / sponsor ID
- 2013-2167
- Conditions
- Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.
SECONDARY OBJECTIVES:
- To determine the effects of a 12-week behavior/exercise intervention on body composition among ethnically diverse endometrial cancer survivors.
TERTIARY OBJECTIVES:
- To determine the effects of a 12-week behavior/exercise intervention for ethnically diverse endometrial cancer survivors on physical function and quality-of-life.
II. To determine the most important behavioral variables for predicting physical activity adherence.
III. To determine the most significant facilitators and barriers to adherence during the 12-week intervention.
IV. To compare the thematic differences between high-adherence and low-adherence participants and qualitatively assess the strengths and weaknesses of the 12-week intervention.
OUTLINE: Participants are randomized to 1 of 2 groups
GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.
GROUP II: Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.
After completion of study, participants are followed up at 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionParticipants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks. |
| wait-list for intervention | No intervention | –Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent form signed and dated by the subject
- English and/or Spanish speaking
- History of endometrial cancer stage I-IV > 6 months < 5 years, not currently receiving cancer treatment
- Overweight (body mass index [BMI] >= 30)
- Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
Key exclusion criteria (2 listed)
- Must not have engaged in a regular (> 3x/week, physical activity program in the last 6 months)
- Medical contraindication to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionParticipate in physical activity behavioral intervention | Behavioural | Exercise Intervention |
Primary outcome
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)
Time frame: 12 weeks
Data will be analyzed using Pearson Chi-square test.
12 secondary outcomes
Barrier avoidance/coping, measured using 5 point Likert scales
Time frame: Up to 12 weeks
BMI
Time frame: Up to 12 weeks
Change in ability to perform activities of daily living, assessed with the YPAS
Time frame: Baseline to 12 weeks
Change in sedentary time, assessed with the YPAS
Time frame: Baseline to 12 weeks
Exercise efficacy, measured using 5 point Likert scales
Time frame: Up to 12 weeks
Fatigue, assessed by the FACT-Fatigue
Time frame: Up to 12 weeks
Outcome expectations, measured using 5 point Likert scales
Time frame: Up to 12 weeks
Physical function score
Time frame: Up to 12 weeks
Quality of life, assessed by the Functional Assessment of Cancer Therapy (FACT)-Endometrial Cancer
Time frame: Up to 12 weeks
Self-regulation, measured using 5 point Likert scales
Time frame: Up to 12 weeks
Social support, measured using 5 point Likert scales
Time frame: Up to 12 weeks
Waist circumference
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Derived from this study: PubMed 36971688Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Nevadunsky principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Stage IA Uterine Corpus Cancer and Stage IB Uterine Corpus Cancer, run by Albert Einstein College of Medicine 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 6 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 16 Sep 2019. 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 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?
Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS) (time frame: 12 weeks). 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 NCT02575872, which also lists 1 linked publication.
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 16 Sep 2019.