Trial Outcomes & Findings for The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors (NCT NCT03641287)
NCT ID: NCT03641287
Last Updated: 2023-11-29
Results Overview
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.
TERMINATED
NA
64 participants
Baseline up to 24 weeks
2023-11-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Exercise on Distress, Quality of Life, and Biomarkers in Ovarian Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm I (Aerobic Exercise)
n=31 Participants
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 II (Habitual Level of Physical Activity)
n=33 Participants
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
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
61.77 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
63.73 years
STANDARD_DEVIATION 10.69 • n=7 Participants
|
62.78 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Body Mass Index
|
26.73 kg/m^2
STANDARD_DEVIATION 5.31 • n=5 Participants
|
28.92 kg/m^2
STANDARD_DEVIATION 7.17 • n=7 Participants
|
27.86 kg/m^2
STANDARD_DEVIATION 6.39 • n=5 Participants
|
|
Stage
Stage II
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Stage
Stage III
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Stage
Stage IV
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 24 weeksWill 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.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=28 Participants
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 II (Habitual Level of Physical Activity)
n=27 Participants
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
|
|---|---|---|
|
Change in Quality of Life Measured Using the RAND 36-item Short Form Health Survey Physical Component Score
|
4.37 score on a scale
Standard Error 0.99
|
4.61 score on a scale
Standard Error 2.02
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksWill 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.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=28 Participants
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 II (Habitual Level of Physical Activity)
n=28 Participants
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
|
|---|---|---|
|
Change in Distress, Measured Using the Perceived Stress Scale
|
-1.4 score on a scale
Standard Error 0.97
|
1.05 score on a scale
Standard Error 1.64
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksWill 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.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=28 Participants
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 II (Habitual Level of Physical Activity)
n=28 Participants
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
|
|---|---|---|
|
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Anxiety Subscale
|
-1.15 score on a scale
Standard Error 0.56
|
-0.15 score on a scale
Standard Error 0.72
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksWill 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.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=28 Participants
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 II (Habitual Level of Physical Activity)
n=28 Participants
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
|
|---|---|---|
|
Change in Distress, Measured Using the Hospital Anxiety and Depression Scale - Depression Subscale
|
-0.76 score on a scale
Standard Error 0.42
|
-0.32 score on a scale
Standard Error 0.80
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksMean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of IL-6.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=25 Participants
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 II (Habitual Level of Physical Activity)
n=23 Participants
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
|
|---|---|---|
|
Change in IL-6 (Biomarker of Angiogenesis)
|
-0.57 pg/mL
Standard Error 2.03
|
0.09 pg/mL
Standard Error 0.54
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksMean change from baseline to 24 weeks between the exercise intervention and control group in mean levels of VEGF.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=25 Participants
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 II (Habitual Level of Physical Activity)
n=23 Participants
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
|
|---|---|---|
|
Change in VEGF (Biomarker of Angiogenesis)
|
-37.3 pg/mL
Standard Error 41.84
|
-82.2 pg/mL
Standard Error 36.35
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksMean change from baseline to 24 weeks between the exercise intervention and control group in mean level of evening salivary cortisol.
Outcome measures
| Measure |
Arm I (Aerobic Exercise)
n=27 Participants
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 II (Habitual Level of Physical Activity)
n=23 Participants
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
|
|---|---|---|
|
Change in Nocturnal Cortisol (Biomarker of Chronic Stress)
|
0.01 ug/dL
Standard Error 0.157
|
0.11 ug/dL
Standard Error 0.07
|
Adverse Events
Arm I (Aerobic Exercise)
Arm II (Habitual Level of Physical Activity)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathryn Pennington, MD
University of Washington Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place