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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.
This was a pilot feasibility study to refine our methodology before a larger Phase II trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Exercise Intervention | Active Comparator | Survivor-only progressive walking and resistance exercise |
|
| Dyadic Exercise Intervention | Experimental | Dyadic progressive walking and resistance exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survivor-only progressive walking and resistance exercise | Behavioral | Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to post-intervention (6 weeks later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to post-intervention (6 weeks later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria for Cancer Survivors:
Inclusion Criteria for Caregivers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Kamen, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Dyadic Exercise Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20). | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention (6 weeks later) |
|
2 years, 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Exercise Intervention - Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 mm segment depression in EKG | Cardiac disorders | Systematic Assessment | 1 mm ST segment depression in Lead II at the end of treadmill test, therefore it was immediately terminated. He was not feeling any discomfort or pain, but because of known heart disease, the exercise physiologist thought it would be best. |
First, this was a pilot, Phase I trial, and hence had a limited sample size. This study was conducted in a single geographic region. Finally, we analyzed only two time points: baseline and post-intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Kamen | University of Rochester | 585-275-9958 | charles_kamen@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Dyadic progressive walking and resistance exercise | Behavioral | Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad |
|
|
| Baseline to post-intervention (6 weeks later) |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
|
| 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. | The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20). | Posted | Mean | Standard Deviation | ng/mL | Baseline to post-intervention (6 weeks later) |
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| 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. | This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20). | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention (6 weeks later) |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Dyadic Exercise Intervention - Cancer Survivors | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) | 0 | 20 | 1 | 20 |
| EG002 | Individual Exercise Intervention - Caregivers | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) | 0 | 22 | 0 | 22 |
| EG003 | Dyadic Exercise Intervention - Caregivers | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) | 0 | 20 | 1 | 20 |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | While exercising, exacerbated her back problems. She has since gone to Chiropractor and massage therapist to help ease pain. Was instructed to stop doing any resistance activity. She will no longer be doing any EXCAP exercises. |
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