Endometrial CancerPhase 1NCT01401829
Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
A Phase 1 study testing 150 weekly minutes walking, 75 weekly minutes walking and Stretching/Flexibility exercise in people with Endometrial Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- 150 weekly minutes walking, 75 weekly minutes walking and Stretching/Flexibility exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2013
- Phase
- Phase 1
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Female, 18 to 70 years of age with history of Stage I, II, or III endometrial cancer diagnosis occurring at least 6 months prior to study enrollment,
- 2) if chemotherapy or radiation therapy was received, patient must be ≥ 4 weeks post final primary treatment administration,
- 3) if patient has undergone surgical procedure, must be ≥ 8 weeks post-procedure or cleared by surgeon for moderate intensity walking,
- 4) English speaking,
- 5) medical clearance for participation provided by primary care physician or oncologist,
- 6) average fatigue over the past week of ≥3 on a 1 to 10 Likert scale or worrying thoughts ≥ a lot of the time or enjoy the things they used to a little/ not at all.
Who cannot join
- 1) metastatic or recurrent endometrial cancer,
- 2) inability to ambulate without assistance,
- 3) unstable angina,
- 4) New York Heart Association class II, III, or IV congestive heart failure,
- 5) uncontrolled asthma,
- 6) having been told by a physician to only do exercise prescribed by a physician,
Show all 16Show fewer
- 7) dementia or organic brain syndrome,
- 8) schizophrenia or active psychosis,
- 9) participating, on average, in more than 20 minutes of physical activity on two or more days per week during the past six months,
- 10) anticipates undergoing elective surgery during the duration of the intervention which would interfere with the intervention participation,
- 11) does not live or work less than 50 miles from the study site,
- 12) lack of transportation to the study site,
- 13) plans to move residence out of the local area during the study duration,
- 14) plans to travel out of the local area for more than a week during the intervention,
- 15) contraindication to participation in physical activity,
- 16) non-compliant with sleep apnea treatments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.
Read the detailed description
Endometrial cancer is the most prevalent gynecologic cancer in women. Because of its excellent 5 year survival rate of 83%, addressing longer term cancer effects in this group is an important aspect of cancer survivor care. Unfortunately, women with a history of endometrial cancer may report persistent levels of fatigue, depression, and anxiety that are, on average, higher than those of healthy, gynecologic out-patients. Physical activity is one potential approach to reducing these symptoms, but little is known about the effects of physical activity in endometrial cancer survivors specifically. Furthermore, current evidence is insufficient to make recommendations regarding the optimal exercise amount, type, and duration for improving fatigue, depression, or anxiety after a cancer diagnosis (any cancer type).
This pilot, randomized trial is unique in its focus on endometrial cancer survivors, a previously understudied population with a large potential for benefiting from regular physical activity. Two separate walking intervention groups will work with an exercise specialist three times a week to walk for either 75 minutes (group 1) or 150 minutes (group 2) weekly. The participants will start out slowly and then gradually increase to the particular group goal of 75 or 150 minutes. The stretching exercise group will work with an exercise specialist doing stretching/flexibility exercises three times a week starting with 15 seconds and then gradually increasing to 30 seconds of holding the stretch.
- Conditions
- Endometrial Cancer
- Being tested
- 150 weekly minutes walking, 75 weekly minutes walking, Stretching/Flexibility exercise
- Keywords
- endometrial cancer, aerobic walking, stretching/flexibility exercises, quality of life
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 weekly minutes walkingBehavioural
Also called moderate intensity aerobic walking
12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
75 weekly minutes walkingBehavioural
Also called moderate intensity aerobic walking
12 week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
Stretching/Flexibility exerciseBehavioural
Also called stretching exercise
12 week stretching intervention group with a goal of 3 sessions per week while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
| Study group | Role | What they receive |
|---|---|---|
| 75 weekly minutes walking | Experimental | 12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week Receives: Behavioral: 75 weekly minutes walking |
| 150 weekly minutes walking | Experimental | 12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week Receives: Behavioral: 150 weekly minutes walking |
| Stretching and Flexibility exercise | Active comparator | Stretching/Flexibility exercise Receives: Behavioral: Stretching/Flexibility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]
Measured: Change from baseline at 12 weeks
Secondary outcomes (18)
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Measured: Change from baseline at 8 weeks
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Measured: Change in baseline at 12 weeks
Task self-efficacy
4 item scale for chronic disease patients
Measured: Change in baseline at 8 weeks
Task self-efficacy
4 item scale for chronic disease patients
Measured: Change in baseline at 12 weeks
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Measured: Change in baseline at 8 weeks
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Measured: Change in baseline at 12 weeks
Body Mass Index (BMI)
BMI calculated with weight and height
Measured: Change in baseline at 8 weeks
Body Mass Index (BMI)
BMI calculated with weight and height
Measured: Change in baseline at 12 weeks
Body Composition
Bioelectrical Impedance
Measured: Change in baseline at 8 weeks
Body Composition
Bioelectrical Impedance
Measured: Change in baseline at 12 weeks
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
Measured: Change in baseline at 8 weeks
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
Measured: Change in baseline at 12 weeks
fitness
submaximal fitness test
Measured: Change in baseline at 8 weeks
fitness
submaximal fitness test
Measured: Change in baseline at 12 weeks
muscle strength
back/leg dynamometer and hand grip dynamometer
Measured: Change in baseline at 8 weeks
muscle strength
back/leg dynamometer and hand grip dynamometer
Measured: Change in baseline at 12 weeks
feasibility
Number of patients recruited, Number of patients who complete the walking intervention, Number of adverse events reported, and Number of patients who complete the study
Measured: one year
demographic, lifestyle, and medical covariates
self-administered survey
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Terminated due to lack of funding required to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Q. Rogers, MD, MPH, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401829
- Sponsor's protocol ID
- ROG-SIU-11-004
- Status last verified
- May 2015
- First submitted
- 21 Jul 2011
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rogers LQ. Objective monitoring of physical activity after a cancer diagnosis: challenges and opportunities for enhancing cancer control. Phys Ther Rev. 2010 Jun 1;15(3):224-237. doi: 10.1179/174328810X12814016178872.
PubMed 21603254Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.
PubMed 21558582Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
PubMed 19383889Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.
PubMed 19340875Rogers LQ, Courneya KS, Robbins KT, Rao K, Malone J, Seiz A, Reminger S, Markwell SJ, Burra V. Factors associated with fatigue, sleep, and cognitive function among patients with head and neck cancer. Head Neck. 2008 Oct;30(10):1310-7. doi: 10.1002/hed.20873.
PubMed 18642320Rogers LQ, Markwell SJ, Courneya KS, McAuley E, Verhulst S. Exercise preference patterns, resources, and environment among rural breast cancer survivors. J Rural Health. 2009 Fall;25(4):388-91. doi: 10.1111/j.1748-0361.2009.00249.x.
PubMed 19780920
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT01401829
- Acronym / sponsor ID
- ROG-SIU-11-004
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, aerobic walking, stretching/flexibility exercises, quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of funding required to continue the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Jul 2011 (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.
To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.
Detailed description
Endometrial cancer is the most prevalent gynecologic cancer in women. Because of its excellent 5 year survival rate of 83%, addressing longer term cancer effects in this group is an important aspect of cancer survivor care. Unfortunately, women with a history of endometrial cancer may report persistent levels of fatigue, depression, and anxiety that are, on average, higher than those of healthy, gynecologic out-patients. Physical activity is one potential approach to reducing these symptoms, but little is known about the effects of physical activity in endometrial cancer survivors specifically. Furthermore, current evidence is insufficient to make recommendations regarding the optimal exercise amount, type, and duration for improving fatigue, depression, or anxiety after a cancer diagnosis (any cancer type).
This pilot, randomized trial is unique in its focus on endometrial cancer survivors, a previously understudied population with a large potential for benefiting from regular physical activity. Two separate walking intervention groups will work with an exercise specialist three times a week to walk for either 75 minutes (group 1) or 150 minutes (group 2) weekly. The participants will start out slowly and then gradually increase to the particular group goal of 75 or 150 minutes. The stretching exercise group will work with an exercise specialist doing stretching/flexibility exercises three times a week starting with 15 seconds and then gradually increasing to 30 seconds of holding the stretch.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 75 weekly minutes walking | Experimental | Behavioral: 75 weekly minutes walking12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week |
| 150 weekly minutes walking | Experimental | Behavioral: 150 weekly minutes walking12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week |
| Stretching and Flexibility exercise | Active comparator | Behavioral: Stretching/Flexibility exerciseStretching/Flexibility exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) Female, 18 to 70 years of age with history of Stage I, II, or III endometrial cancer diagnosis occurring at least 6 months prior to study enrollment,
- 2) if chemotherapy or radiation therapy was received, patient must be ≥ 4 weeks post final primary treatment administration,
- 3) if patient has undergone surgical procedure, must be ≥ 8 weeks post-procedure or cleared by surgeon for moderate intensity walking,
- 4) English speaking,
- 5) medical clearance for participation provided by primary care physician or oncologist,
Key exclusion criteria (16 listed)
- 1) metastatic or recurrent endometrial cancer,
- 2) inability to ambulate without assistance,
- 3) unstable angina,
- 4) New York Heart Association class II, III, or IV congestive heart failure,
- 5) uncontrolled asthma,
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 |
|---|---|---|
| 150 weekly minutes walkingAlso: moderate intensity aerobic walking12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety | Behavioural | 150 weekly minutes walking |
| 75 weekly minutes walkingAlso: moderate intensity aerobic walking12 week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety | Behavioural | 75 weekly minutes walking |
| Stretching/Flexibility exerciseAlso: stretching exercise12 week stretching intervention group with a goal of 3 sessions per week while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety | Behavioural | Stretching and Flexibility exercise |
Primary outcome
fatigue
Time frame: Change from baseline at 12 weeks
13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]
18 secondary outcomes
Depression and Anxiety
Time frame: Change from baseline at 8 weeks
Depression and Anxiety
Time frame: Change in baseline at 12 weeks
Task self-efficacy
Time frame: Change in baseline at 8 weeks
Task self-efficacy
Time frame: Change in baseline at 12 weeks
Quality of Life
Time frame: Change in baseline at 8 weeks
Quality of Life
Time frame: Change in baseline at 12 weeks
Body Mass Index (BMI)
Time frame: Change in baseline at 8 weeks
Body Mass Index (BMI)
Time frame: Change in baseline at 12 weeks
Body Composition
Time frame: Change in baseline at 8 weeks
Body Composition
Time frame: Change in baseline at 12 weeks
Waist and Hip circumferences
Time frame: Change in baseline at 8 weeks
Waist and Hip circumferences
Time frame: Change in baseline at 12 weeks
fitness
Time frame: Change in baseline at 8 weeks
fitness
Time frame: Change in baseline at 12 weeks
muscle strength
Time frame: Change in baseline at 8 weeks
muscle strength
Time frame: Change in baseline at 12 weeks
feasibility
Time frame: one year
demographic, lifestyle, and medical covariates
Time frame: one year
Results and safety
The study was stopped early (reason given: Terminated due to lack of funding required to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 21603254Rogers LQ. Objective monitoring of physical activity after a cancer diagnosis: challenges and opportunities for enhancing cancer control. Phys Ther Rev. 2010 Jun 1;15(3):224-237. doi: 10.1179/174328810X12814016178872.
- Background: PubMed 21558582Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.
- Background: PubMed 19383889Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
- Background: PubMed 19340875Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.
- Background: PubMed 18642320Rogers LQ, Courneya KS, Robbins KT, Rao K, Malone J, Seiz A, Reminger S, Markwell SJ, Burra V. Factors associated with fatigue, sleep, and cognitive function among patients with head and neck cancer. Head Neck. 2008 Oct;30(10):1310-7. doi: 10.1002/hed.20873.
- Background: PubMed 19780920Rogers LQ, Markwell SJ, Courneya KS, McAuley E, Verhulst S. Exercise preference patterns, resources, and environment among rural breast cancer survivors. J Rural Health. 2009 Fall;25(4):388-91. doi: 10.1111/j.1748-0361.2009.00249.x.
- American Cancer SocietyLink provided by the sponsor.
- American College of Sports MedicineLink provided by the sponsor.
- National Cancer Institute of the National Institutes of HealthLink provided by the sponsor.
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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.
Laura Q. Rogers, MD, MPH principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 150 weekly minutes walking, 75 weekly minutes walking and Stretching/Flexibility exercise in people with Endometrial Cancer, run by University of Alabama at Birmingham 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 16 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 12 May 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to lack of funding required to continue the study.). 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?
fatigue (time frame: Change from baseline at 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 NCT01401829, which also lists 6 linked publications.
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 12 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.