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| Name | Class |
|---|---|
| Brown University | OTHER |
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Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral internet program | Active Comparator | Participants randomized to the Internet program will receive a 12-week behavioral Internet program designed to increase physical activity to recommended levels. |
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| Informational newsletter condition | Sham Comparator | Participants randomized to the newsletter condition will receive 6 newsletters, delivered every other week during the 3-month program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Internet program | Behavioral | The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants will be asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity | baseline to 3 months |
| Intervention Engagement - Planning of Physical Activity (Internet Program Only) | Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant. | weekly from weeks 2-12 |
| Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only) | Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period. | weekly during weeks 1-12 |
| Program Satisfaction Via Likert Scale | Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Measured Via the Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital's Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Internet Program | Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels. Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments. |
| FG001 | Informational Newsletter Condition | Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program. Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Internet Program | Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels. Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Physical Activity | Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity | Posted | Mean | Standard Deviation | minutes per week | baseline to 3 months |
|
Data were collected over the 3-month intervention period.
Participants were instructed to inform the research staff if they had any injury or illnesses throughout the intervention period. Further, at the 3-month assessment visit, participants were queried regarding any potential adverse events over the past 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 | Behavioral Internet Program | Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels. Behavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Unick | The Miriam Hospital | 401-793-7966 | junick@brownhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2022 | Feb 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | Feb 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Informational newsletter condition | Behavioral | Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines. |
|
| baseline to 3 months |
| Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 | The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health). | baseline to 3 months |
| Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18) | Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety. | baseline to 3 months |
| Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) | A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence) | baseline to 3 months |
| BG001 | Informational Newsletter Condition | Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program. Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program. Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines. |
|
|
| Primary | Intervention Engagement - Planning of Physical Activity (Internet Program Only) | Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant. | Posted | Mean | Standard Deviation | percentage of weeks | weekly from weeks 2-12 |
|
|
|
| Primary | Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only) | Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period. | Posted | Mean | Standard Deviation | percentage of weeks | weekly during weeks 1-12 |
|
|
|
| Primary | Program Satisfaction Via Likert Scale | Participants used a 1-7 Likert scale to answer 'how satisfied are you with the program received?" (higher score indicates greater satisfaction) | Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Fatigue Measured Via the Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue). | Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
|
|
| Secondary | Health-related Quality of Life (General Health Subscale) Measured Via the SF-36 | The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health). | Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
|
|
| Secondary | Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18) | Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety. | Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
|
|
| Secondary | Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI) | A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence) | Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure. | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
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| 0 |
| 23 |
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| 23 |
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| 23 |
| EG001 | Informational Newsletter Condition | Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program. Informational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines. | 0 | 23 | 0 | 23 | 0 | 23 |
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