An interventional study of Exercise Counseling and Aerobic Exercise in Ovarian Cancer, Fallopian Tube Adenocarcinoma and Fallopian Tube Carcinosarcoma, sponsored by University of Washington. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
51 studies on the registry are indexed under Brenner Tumor; none are open to participants now.
This study's enrollment of 64 is above the median of 57 across 38 interventional studies indexed under Brenner Tumor.
Browse Brenner Tumor studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Compared within Brenner Tumor, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ovarian Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnancy and the need for :
* 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: Aerobic Exercise · Other: Physiological Support · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
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 · Other: Questionnaire Administration · Other: Best Practice
Meet with exercise physiology
Receive prescription for moderate aerobic exercise
Also known as: Aerobic Activity, aerobic exercise
Receive motivational support via telephone care
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo habitual level of physical activity
Also known as: best practice, standard of care, standard of care, standard therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 24 weeks
| Milestone | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Started | 31 | 33 |
| Completed | 28 | 33 |
| Not completed | 3 | 0 |
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.
| score on a scale | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score | 4.37 ± 0.99 | 4.61 ± 2.02 |
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.
| score on a scale | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in Distress, Measured Using the Perceived Stress Scale | -1.4 ± 0.97 | 1.05 ± 1.64 |
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.
| score on a scale | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale | -1.15 ± 0.56 | -0.15 ± 0.72 |
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.
| score on a scale | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale | -0.76 ± 0.42 | -0.32 ± 0.80 |
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6.
| pg/mL | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in IL-6 (Biomarker of Angiogenesis) | -0.57 ± 2.03 | 0.09 ± 0.54 |
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.
| pg/mL | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in VEGF (Biomarker of Angiogenesis) | -37.3 ± 41.84 | -82.2 ± 36.35 |
Mean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.
| ug/dL | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) |
|---|---|---|
| Change in Nocturnal Cortisol (Biomarker of Chronic Stress) | 0.01 ± 0.157 | 0.11 ± 0.07 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Aerobic Exercise) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Arm II (Habitual Level of Physical Activity) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 16 | 18 | 34 |
| Age, Continuous(years) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| Mean | 61.77 ± 9.68 | 63.73 ± 10.69 | 62.78 ± 10.18 |
| Sex: Female, Male(Participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| Female | 31 | 33 | 64 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 27 | 31 | 58 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 1 | 2 |
| White | 28 | 26 | 54 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| United States | 31 | 33 | 64 |
| Body Mass Index(kg/m^2) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| Mean | 26.73 ± 5.31 | 28.92 ± 7.17 | 27.86 ± 6.39 |
| Stage(Participants) | Arm I (Aerobic Exercise) | Arm II (Habitual Level of Physical Activity) | Total |
|---|---|---|---|
| Stage II | 3 | 4 | 7 |
| Stage III | 22 | 17 | 39 |
| Stage IV | 6 | 12 | 18 |
PDFs hosted by the registry, ClinicalTrials.gov.
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