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Psychosocial Benefits of Exercise in Endometrial Cancer Survivors


Phase 1
18 Years
70 Years
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Psychosocial Benefits of Exercise in Endometrial Cancer Survivors


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.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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,

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

fatigue

Outcome Description:

13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]

Outcome Time Frame:

Change from baseline at 12 weeks

Safety Issue:

No

Principal Investigator

Laura Q. Rogers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southern Illinois University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

ROG-SIU-11-004

NCT ID:

NCT01401829

Start Date:

July 2011

Completion Date:

September 2013

Related Keywords:

  • Endometrial Cancer
  • endometrial cancer
  • aerobic walking
  • stretching/flexibility exercises
  • quality of life
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Southern Illinois University School of Medicine Springfield, Illinois  62794-9658