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| ID | Type | Description | Link |
|---|---|---|---|
| 10045 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2018-01630 | Registry Identifier | NCI / CTRP | |
| R21CA215662 | U.S. NIH Grant/Contract | View source |
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Enrollment ended early due to the funding timeline
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (aerobic exercise) | Experimental | 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. |
|
| Arm II (habitual level of physical activity) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Counseling | Other | Meet with exercise physiology |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score | 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. RAND 36-Item Short Form assesses eight subscales including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health. Possible scores for each subscale range from 0 to 100. The Physical Component Score (PCS) is an aggregate of the eight subscales using a standardized algorithm, with a mean of 50 and standard deviation of 10 in the general US population. Possible scores range from 20 to 60, with higher scores indicating a better quality of life. | Baseline up to 24 weeks |
| Change in Distress, Measured Using the Perceived Stress Scale | 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 Perceived Stress Scale is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher distress. | Baseline to 24 weeks |
| Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale | Will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - anxiety subscale. The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression. The Hospital Anxiety and Depression Scale - anxiety subscale total scores range from 0 to 21; higher scores indicated greater severity of anxiety symptoms. | Baseline to 24 weeks |
| Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Pennington | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Exercise Counseling: Meet with exercise physiology Aerobic Exercise: Receive prescription for moderate aerobic exercise Physiological Support: Receive motivational support via telephone care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2020 |
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| Aerobic Exercise |
| Other |
Receive prescription for moderate aerobic exercise |
|
|
| Physiological Support | Other | Receive motivational support via telephone care |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Best Practice | Other | Undergo habitual level of physical activity |
|
|
Will be measured using the Hospital Anxiety and Depression Scale - Depression sub scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - Depression subscale. The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression. The Hospital Anxiety and Depression Scale - Depression subscale total scores range from 0 to 21; higher scores indicated greater severity of depression symptoms. |
| Baseline to 24 weeks |
| Change in IL-6 (Biomarker of Angiogenesis) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6. | Baseline to 24 weeks |
| Change in VEGF (Biomarker of Angiogenesis) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF. | Baseline to 24 weeks |
| Change in Nocturnal Cortisol (Biomarker of Chronic Stress) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol. | Baseline to 24 weeks |
| FG001 | 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. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Best Practice: Undergo habitual level of physical activity |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Exercise Counseling: Meet with exercise physiology Aerobic Exercise: Receive prescription for moderate aerobic exercise Physiological Support: Receive motivational support via telephone care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | 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. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Best Practice: Undergo habitual level of physical activity |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Stage | Cancer is staged as stage I, II, III, or IV using FIGO 2014 staging system. A higher stage is associated with worse prognosis. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score | 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. RAND 36-Item Short Form assesses eight subscales including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health. Possible scores for each subscale range from 0 to 100. The Physical Component Score (PCS) is an aggregate of the eight subscales using a standardized algorithm, with a mean of 50 and standard deviation of 10 in the general US population. Possible scores range from 20 to 60, with higher scores indicating a better quality of life. | Posted | Mean | Standard Error | score on a scale | Baseline up to 24 weeks |
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| Primary | Change in Distress, Measured Using the Perceived Stress Scale | 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 Perceived Stress Scale is a 10 item questionnaire with a total score range of 0-40. Higher total scores indicate higher distress. | Posted | Mean | Standard Error | score on a scale | Baseline to 24 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale | Will be measured using the Hospital Anxiety and Depression Scale - Anxiety subscale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - anxiety subscale. The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression. The Hospital Anxiety and Depression Scale - anxiety subscale total scores range from 0 to 21; higher scores indicated greater severity of anxiety symptoms. | Posted | Mean | Standard Error | score on a scale | Baseline to 24 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale | Will be measured using the Hospital Anxiety and Depression Scale - Depression sub scale. Mean change from baseline to 24 weeks between the exercise intervention and control group in the Hospital Anxiety and Depression Scale - Depression subscale. The Hospital Anxiety and Depression Scale includes 2 subscales: anxiety and depression. The Hospital Anxiety and Depression Scale - Depression subscale total scores range from 0 to 21; higher scores indicated greater severity of depression symptoms. | Posted | Mean | Standard Error | score on a scale | Baseline to 24 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change in IL-6 (Biomarker of Angiogenesis) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6. | Posted | Mean | Standard Error | pg/mL | Baseline to 24 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change in VEGF (Biomarker of Angiogenesis) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF. | Posted | Mean | Standard Error | pg/mL | Baseline to 24 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Change in Nocturnal Cortisol (Biomarker of Chronic Stress) | Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol. | Posted | Mean | Standard Error | ug/dL | Baseline to 24 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Exercise Counseling: Meet with exercise physiology Aerobic Exercise: Receive prescription for moderate aerobic exercise Physiological Support: Receive motivational support via telephone care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | 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. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Best Practice: Undergo habitual level of physical activity | 0 | 33 | 0 | 33 | 0 | 33 |
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Enrollment ended before meeting accrual goal due to the funding timeline, leading to smaller numbers of participants analyzed.
Most participants completed the study after the COVID-19 pandemic began. The study continued for several years during the pandemic. Multiple surges occurred and there was variable timing of infections experienced by participants and their loved ones over the course of their 6 month study participation. Participants were not uniformly affected by the COVID-19 pandemic.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Pennington, MD | University of Washington Medical Center | 206-598-8300 | katypenn@uw.edu |
| Sep 29, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001948 | Brenner Tumor |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Stage III |
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| Stage IV |
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