Neoplasms

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Ovarian Cancer

Quality of Life

Transitional Cell Carcinoma

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Tannic Acid

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.

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.

Exercise Counseling

Receive prescription for moderate aerobic exercise

Aerobic Exercise

Receive motivational support via telephone care

Physiological Support

Quality-of-Life Assessment

Questionnaire Administration

Undergo habitual level of physical activity

Best Practice

Kathryn Pennington

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.

The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors

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

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.

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.

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.

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.

Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6.

Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.

Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.

National Cancer Institute (NCI)

University of Washington

Assistant Professor

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

Arm I (Aerobic Exercise)

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

Arm II (Habitual Level of Physical Activity)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index

Stage II

Stage III

Stage IV

Cancer is staged as stage I, II, III, or IV using FIGO 2014 staging system. A higher stage is associated with worse prognosis.

Stage

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.

Kathryn Pennington, MD

Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score

Change in Distress, Measured Using the Perceived Stress Scale

Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale

Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale

Change in IL-6 (Biomarker of Angiogenesis)

Change in VEGF (Biomarker of Angiogenesis)

Change in Nocturnal Cortisol (Biomarker of Chronic Stress)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors	NCT03641287	Ovarian Cancer Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Ovari... Ovarian Adenoca... Ovarian Carcino... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Primary Periton... Primary Periton...	Exercise Counse... Aerobic Exercis... Physiological S... Quality-of-Life... Questionnaire A... Best Practice	18 Years -	University of Washington
The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors	NCT03641287	Ovarian Cancer Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Ovari... Ovarian Adenoca... Ovarian Carcino... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Primary Periton... Primary Periton...	Exercise Counse... Aerobic Exercis... Physiological S... Quality-of-Life... Questionnaire A... Best Practice	18 Years -	University of Washington

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