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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00647 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 99516 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| R01MH084723 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on the health and well-being of young adults with cancer.
PRIMARY OBJECTIVES:
I. To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.
II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.
SECONDARY OBJECTIVES:
I. To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.
OUTLINE:
Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.
After completion of study, patients are followed up at 1 and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care | Experimental | Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Complete online PA program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability - Mean Value | Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? | At 12 weeks |
| Acceptability - Proportion Value | Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? | At 12 weeks |
| Accrual | Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution. | Up to 19 months |
| Adherence - Proportion of Completed Interventions (Mean Value) | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Salsman | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Comprehensive Cancer Center of Wake Forest University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36890329 | Derived | Salsman JM, McLouth LE, Tooze JA, Little-Greene D, Cohn M, Kehoe MS, Moskowitz JT. An eHealth, Positive Emotion Skills Intervention for Enhancing Psychological Well-Being in Young Adult Cancer Survivors: Results from a Multi-Site, Pilot Feasibility Trial. Int J Behav Med. 2023 Oct;30(5):639-650. doi: 10.1007/s12529-023-10162-5. Epub 2023 Mar 8. | |
| 32463014 | Derived | Salsman JM, McLouth LE, Cohn M, Tooze JA, Sorkin M, Moskowitz JT. A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care | Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care | Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| 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 | Acceptability - Mean Value | Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? | Only 26 participants out of the 43 were analyzed for acceptability for this outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | At 12 weeks |
|
Up to 19 months
Adverse events were not monitored/assessed for this trial.
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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 | Supportive Care | Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. Internet-Based Intervention: Complete online PA program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study coordinator | Wake Forest University Health Sciences | 336-713-5061 | drlittle@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2017 | May 13, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2018 | May 13, 2020 | ICF_001.pdf |
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| Quality-of-Life Assessment |
| Procedure |
Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| At 12 weeks |
| Adherence - Proportion of Completed Interventions (Proportion Value) | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions. | At 12 weeks |
| Number of Patients Who Refused to Participate | The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible. | At 12 weeks |
| Number of Patient Provided Data at 8 Weeks - Retention | Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site | At 8 week |
| Adherence - Number of Completed Exercises | Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. | At 12 weeks |
| Number of Website Visits | Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. | At 12 weeks |
| Number of Patients Provided Data at 12 Weeks - Retention | Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. | At 12 weeks |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Acceptability - Proportion Value | Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? | Only 26 participants out of the 43 were analyzed for acceptability for this outcome. | Posted | Number | 95% Confidence Interval | proportion of participants | At 12 weeks |
|
|
|
| Primary | Accrual | Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution. | Posted | Mean | 95% Confidence Interval | participants per month | Up to 19 months |
|
|
|
| Primary | Adherence - Proportion of Completed Interventions (Mean Value) | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions. | Posted | Mean | Standard Deviation | completed interventions | At 12 weeks |
|
|
|
| Primary | Adherence - Proportion of Completed Interventions (Proportion Value) | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions. | Posted | Mean | Standard Deviation | complete interventions | At 12 weeks |
|
|
|
| Primary | Number of Patients Who Refused to Participate | The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible. | Posted | Count of Participants | Participants | No | At 12 weeks |
|
|
|
| Primary | Number of Patient Provided Data at 8 Weeks - Retention | Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site | Posted | Count of Participants | Participants | At 8 week |
|
|
|
| Primary | Adherence - Number of Completed Exercises | Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. | Posted | Mean | Standard Deviation | completed exercises | At 12 weeks |
|
|
|
| Primary | Number of Website Visits | Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. | Posted | Mean | Standard Deviation | website visits | At 12 weeks |
|
|
|
| Primary | Number of Patients Provided Data at 12 Weeks - Retention | Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. | Posted | Count of Participants | Participants | At 12 weeks |
|
|
|
| 0 |
| 43 |
| 0 |
| 0 |
| 0 |
| 0 |
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