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The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03641287
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE August 15, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date October 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Change in distress, measured using the Perceived Stress Scale [ Time Frame: Baseline to 24 weeks ]
    Mean change from baseline to 24 weeks between the exercise intervention and control group in the Perceived Stress Scale. The generalized estimating equations (GEE) modification of linear regression will be used in order to model the relationship between the outcome measures and exercise intervention and to account for the correlation within individual data over time.
  • Change in distress, measured using the Hospital Anxiety and Depression Scale anxiety [ Time Frame: Baseline to 24 weeks ]
    Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale anxiety. The generalized estimating equations (GEE) modification of linear regression will be used in order to model the relationship between the outcome measures and exercise intervention and to account for the correlation within individual data over time.
  • Change in quality of life measured using the RAND 36-item Short Form Health Survey Physical Component Score [ Time Frame: Baseline up to 24 weeks ]
    Mean change from baseline to 24 weeks between the exercise intervention and control group in the RAND 36-item Short Form Health Survey Physical Component Score.
  • Change in IL-6 and VEGF (biomarkers of angiogenesis) [ Time Frame: Baseline to 24 weeks ]
    Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6 and VEGF.
  • Change in nocturnal cortisol (biomarker of chronic stress) [ Time Frame: Baseline to 24 weeks ]
    Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors
Official Title  ICMJE The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors - a Randomized Controlled Trial
Brief Summary Many women with ovarian cancer experience distress, fatigue, weakness, anxiety, and other symptoms that decrease quality of life. Moderate exercise may improve quality of life, decrease distress, and improve biomarkers associated with prognosis in women with ovarian cancer. This clinical trial studies how well moderate exercise works in improving distress, quality of life, and biomarkers of angiogenesis and chronic stress in women with ovarian, fallopian tube, and primary peritoneal cancer.
Detailed Description

Patients are randomized to 1 of 2 arms.

ARM I (EXERCISE INTERVENTION): Patients meet with exercise physiologist for 1, 60 minute session. Patients then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Patients also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks.

ARM II (CONTROL GROUP): Patients maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, patients are offered exercise intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Ovarian Adenocarcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Ovarian Undifferentiated Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Carcinosarcoma
  • Primary Peritoneal Transitional Cell Carcinoma
Intervention  ICMJE
  • Other: Exercise Counseling
    Meet with exercise physiology
  • Other: Aerobic Exercise
    Receive prescription for moderate aerobic exercise
    Other Name: Aerobic Activity, aerobic exercise
  • Other: Physiological Support
    Receive motivational support via telephone care
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Best Practice
    Undergo habitual level of physical activity
    Other Name: best practice, standard of care, standard of care, standard therapy
Study Arms  ICMJE
  • Experimental: Arm I (aerobic exercise)
    Participants meet with exercise physiologist for 1, 60 minute session. Participants then receive individualized exercise prescription with goal of moderate aerobic exercise over 150 minutes per week at home for up to 24 weeks. Participants also receive telephone-based motivational support by exercise physiologist weekly for 24 weeks.
    Interventions:
    • Other: Exercise Counseling
    • Other: Aerobic Exercise
    • Other: Physiological Support
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Active Comparator: Arm II (habitual level of physical activity)
    Participants maintain habitual levels of physical activity and receive general education material about ovarian cancer and survivorship for 24 weeks. After 24 weeks, participants are offered exercise intervention.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Best Practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 24, 2021
Estimated Primary Completion Date October 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed stage II-IV epithelial ovarian, fallopian tube, or peritoneal cancer. If site of origin cannot be specified, carcinoma of Mullerian origin may be included if most consistent with ovarian/fallopian tube/peritoneal origin rather than uterine origin. The following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, clear cell carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, undifferentiated carcinoma, carcinosarcoma, or adenocarcinoma not otherwise specified. Women with neoplasms of low malignant potential (borderline tumors) are not eligible.
  • Subjects must have no evidence of disease, as defined by their treating oncologist, and with normal CA-125 (=< 35).
  • Subjects must have completed primary surgery and adjuvant chemotherapy for treatment of ovarian, fallopian tube, of peritoneal cancer within one to six months of screening. Maintenance therapy will be allowed as long as the participant is in clinical remission- including hormonal agents, anti-angiogenesis agents, PARP inhibitors, and immunotherapy. Prior radiation therapy is allowed, as long as it has been completed within one to six months of screening. Subjects may have received prior therapies (including surgery, chemotherapy, radiation therapy) for other malignancies in the past.
  • Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
  • Pregnancy and the need for contraception:

    * Participants with ovarian cancer have undergone hysterectomy with removal of ovaries and tubes as part of surgical treatment, and therefore do not have the potential to become pregnant.

  • Ambulatory.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Women participating in other clinical trials are eligible provided their enrollment in the other trial does not impair their ability to participate in the physical activity interventions and study assessments required in this trial. The other clinical trial must not be a behavioral intervention trial.

Exclusion Criteria:

  • Subjects who have had primary surgery, chemotherapy and/or radiation therapy within 4 weeks prior to screening. Subjects may have received other surgeries not performed for primary treatment (for example, removal of intraperitoneal port, laparoscopic cholecystectomy, etc.) within 1 month of screening as long as they do not have post-operative restrictions that would preclude participating in a moderate intensity exercise program once enrolled in the clinical trial.
  • Self-reported inability to walk at least 2 blocks (at any pace).
  • Prior brain metastasis is not an exclusion, as long as subject is in clinical remission.
  • Uncontrolled or concurrent illness including, but not limited to: unstable angina pectoris, recent (within six months) myocardial infarction, uncontrolled cardiac arrhythmia, uncontrolled congestive heart failure, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension (systolic > 200, diastolic > 120), conditions (cardiovascular, respiratory, or musculoskeletal disease or joint problems) that preclude moderate physical activity. Subjects with a history of cardiac arrest, or those with moderate/severe aortic or mitral stenosis may be eligible if their treating physician determines that moderate physical activity is safe. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. Women with lymphedema or peripheral neuropathy will not be excluded. They will be evaluated by the exercise physiologist for safety and modifications to the exercise prescription will be made as appropriate.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Already physically active > 90 minutes per week of moderate exercise.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathryn Pennington 206-598-8300 katypenn@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641287
Other Study ID Numbers  ICMJE RG1001826
10045 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
NCI-2018-01630 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
R21CA215662 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kathryn Pennington University of Washington
PRS Account University of Washington
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP