Trial Outcomes & Findings for Exercise Intervention for Cancer Survivors and Caregivers (NCT NCT01883635)
NCT ID: NCT01883635
Last Updated: 2016-02-05
Results Overview
Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.
COMPLETED
PHASE1
44 participants
Baseline to post-intervention (6 weeks later)
2016-02-05
Participant Flow
Both cancer survivors and their caregivers were screened, consented, and randomized to one of two intervention arms (Individual Exercise or Dyadic Exercise). 22 cancer survivor/caregiver dyads were recruited (44 individuals).
Participant milestones
| Measure |
Individual Exercise Intervention
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Individual Exercise Intervention
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Exercise Intervention for Cancer Survivors and Caregivers
Baseline characteristics by cohort
| Measure |
Individual Exercise Intervention
n=24 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
n=20 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Continuous
|
56.17 Years
STANDARD_DEVIATION 11.05 • n=93 Participants
|
53.90 Years
STANDARD_DEVIATION 12.59 • n=4 Participants
|
55.12 Years
STANDARD_DEVIATION 11.71 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
20 participants
n=4 Participants
|
44 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-intervention (6 weeks later)Population: The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).
Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.
Outcome measures
| Measure |
Individual Exercise Intervention
n=22 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
n=20 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
|---|---|---|
|
Psychological Distress
|
2.25 units on a scale
Standard Deviation 14.24
|
-.65 units on a scale
Standard Deviation 9.84
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (6 weeks later)Population: The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).
We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.
Outcome measures
| Measure |
Individual Exercise Intervention
n=22 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
n=20 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
|---|---|---|
|
Immune Biomarkers
|
1.17 ng/mL
Standard Deviation 1.57
|
1.42 ng/mL
Standard Deviation 1.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to post-intervention (6 weeks later)Population: This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).
Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.
Outcome measures
| Measure |
Individual Exercise Intervention
n=22 Participants
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
Dyadic Exercise Intervention
n=20 Participants
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
Progressive walking and resistance exercise program
|
|---|---|---|
|
Provision of Social Support
|
-2.90 units on a scale
Standard Deviation 1.03
|
-1.90 units on a scale
Standard Deviation 1.10
|
Adverse Events
Individual Exercise Intervention - Cancer Survivors
Dyadic Exercise Intervention - Cancer Survivors
Individual Exercise Intervention - Caregivers
Dyadic Exercise Intervention - Caregivers
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Individual Exercise Intervention - Cancer Survivors
n=22 participants at risk
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
|
Dyadic Exercise Intervention - Cancer Survivors
n=20 participants at risk
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
|
Individual Exercise Intervention - Caregivers
n=22 participants at risk
Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
|
Dyadic Exercise Intervention - Caregivers
n=20 participants at risk
Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
|
|---|---|---|---|---|
|
Cardiac disorders
1 mm segment depression in EKG
|
0.00%
0/22 • 2 years, 3 months
|
0.00%
0/20 • 2 years, 3 months
|
0.00%
0/22 • 2 years, 3 months
|
5.0%
1/20 • Number of events 1 • 2 years, 3 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/22 • 2 years, 3 months
|
5.0%
1/20 • Number of events 1 • 2 years, 3 months
|
0.00%
0/22 • 2 years, 3 months
|
0.00%
0/20 • 2 years, 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place