Cancer
Conditions
Brief summary
The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.
Detailed description
This was a pilot feasibility study to refine our methodology before a larger Phase II trial.
Interventions
BEHAVIORALSurvivor-only progressive walking and resistance exercise
Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only
BEHAVIORALDyadic progressive walking and resistance exercise
Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Cancer Survivors: * Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months. * Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments * Have a caregiver willing to participate int he study * Be able to read English * Be 21 years of age or older * Give written informed consent Inclusion Criteria for Caregivers: * Be nominated by a cancer survivor * Be able to read English * Be 21 years of age or older * Give written informed consent
Exclusion criteria
* have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor. * For caregivers, be currently undergoing active treatment for cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | Baseline to post-intervention (6 weeks later) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Biomarkers | Baseline to post-intervention (6 weeks later) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Provision of Social Support | Baseline to post-intervention (6 weeks later) | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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 | 20 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Individual Exercise Intervention | Dyadic Exercise Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 16 Participants | 35 Participants |
| Age, Continuous | 56.17 Years STANDARD_DEVIATION 11.05 | 53.90 Years STANDARD_DEVIATION 12.59 | 55.12 Years STANDARD_DEVIATION 11.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 19 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 20 Participants | 44 Participants |
| Region of Enrollment United States | 24 participants | 20 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 1 / 20 | 0 / 22 | 1 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 | 0 / 22 | 0 / 20 |
Outcome results
Primary
Psychological Distress
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Exercise Intervention | Psychological Distress | 2.25 units on a scale | Standard Deviation 14.24 |
| Dyadic Exercise Intervention | Psychological Distress | -.65 units on a scale | Standard Deviation 9.84 |
p-value: 0.14t-test, 2 sided
Secondary
Immune Biomarkers
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Exercise Intervention | Immune Biomarkers | 1.17 ng/mL | Standard Deviation 1.57 |
| Dyadic Exercise Intervention | Immune Biomarkers | 1.42 ng/mL | Standard Deviation 1.24 |
p-value: 0.65t-test, 2 sided
Other Pre-specified
Provision of Social Support
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Exercise Intervention | Provision of Social Support | -2.90 units on a scale | Standard Deviation 1.03 |
| Dyadic Exercise Intervention | Provision of Social Support | -1.90 units on a scale | Standard Deviation 1.1 |
p-value: 0.51t-test, 2 sided