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

Sponsor

University of Washington (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03641287

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

44.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many individuals 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 individuals 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 individuals with ovarian, fallopian tube, and primary peritoneal cancer.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Exercise Counseling Other: Aerobic Exercise Other: Physiological Support Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Best Practice	N/A

Detailed Description

OUTLINE:

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 5, 2018

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Exercise Counseling Meet with exercise physiology Other: Aerobic Exercise Receive prescription for moderate aerobic exercise Other Names: Aerobic Activity, aerobic exercise Other: Physiological Support Receive motivational support via telephone care Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies
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.	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Other: Best Practice Undergo habitual level of physical activity Other Names: best practice, standard of care, standard of care, standard therapy

Arm

Intervention/Treatment

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.

Other: Exercise Counseling

Meet with exercise physiology

Other: Aerobic Exercise

Receive prescription for moderate aerobic exercise

Other Names:

Aerobic Activity, aerobic exercise

Other: Physiological Support

Receive motivational support via telephone care

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

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.

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Other: Best Practice

Undergo habitual level of physical activity

Other Names:

best practice, standard of care, standard of care, standard therapy

Outcome Measures

Primary Outcome Measures

Change in distress, measured using the Perceived Stress Scale [Baseline to 24 weeks]
Will be measured using the Perceived Stress Scale. 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 [Baseline to 24 weeks]
Will be measured using the Hospital Anxiety and Depression Scale anxiety. 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 [Baseline up to 24 weeks]
Will be measured using the RAND 36-item Short Form Health Survey Physical Component Score. 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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
Individuals participating in most 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. Individuals 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.