Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00583 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9819 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA215134 | U.S. NIH Grant/Contract | View source | |
| RG1001537 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
This phase III trial investigates health informatics and a self-management program for improving the health of cancer survivors after stem cell transplant. After transplant many survivors may feel stressed or may be unsure of what health care they need. A self-management program called "INSPIRE," along with a personalized survivorship care plan may improve stress and health care for transplant survivors.
OUTLINE:
Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.
GROUP II: Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients receive access to the INSPIRE online program after 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (INSPIRE, survivorship care plan) | Experimental | Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. |
|
| Group II (usual care) | Active Comparator | Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients may receive access to the INSPIRE online program after 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice and Internet site with links to existing resources | Other | Receive usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cancer and Treatment Distress (CTXD) | Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of >=.90 was used to categorize participants as high in distress. Participants with scores <.90 were categorized as not distressed. | Up to 12 months |
| Health Care Adherence (HCA)-Cardiometabolic | Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of <.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance. | Up to 12 months |
| Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program. | 6-weeks after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Adherence (HCA)-Subsequent Malignancy Screening | Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. | Up to 12 months |
| PHQ-8 Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Survivorship Needs and Health Related Self-efficacy | Mediators of primary outcomes: assessed by patient questionnaires. | Up to 12 months |
| Reach, Engagement and Fidelity of Web-based Intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| K. Scott Baker | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Loyola University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Number analyzed excludes 34 participants determined to be ineligible after consent and 137 participants identified as not requiring the intervention due to lack of distress and adherence to healthcare screening reccomendations.
This leaves 375 participants included in the final analyses.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group I (INSPIRE, Survivorship Care Plan) | Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan Survey Administration: Ancillary studies |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Jun 28, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Internet, Mobile app and Telehealth Intervention | Other | Receive INSPIRE and survivorship care plan |
|
|
| Survey Administration | Other | Ancillary studies |
|
Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months |
| Up to 12 months |
Process Measures: Rates of participants approached versus registering, rates of visits to the web site, pages viewed, types of modalities used, attrition rates and support requests.
| Up to 12 months |
| Cost and Resources to Maintain Program | Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP. | 12 months |
| Maywood |
| Illinois |
| 60153 |
| United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| National Marrow Donor Program | Minneapolis | Minnesota | 55401 | United States |
| Center for International Blood and Marrow Transplant Research | Minneapolis | Minnesota | 55413-5000 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Oncology at Baylor Charles A Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Group II (Usual Care) |
Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients may receive access to the INSPIRE online program after 12 months. Best Practice and Internet site with links to existing resources: Receive usual care Survey Administration: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Number analyzed excludes 34 participants determined to be ineligible after consent and 137 participants identified as not requiring the intervention due to lack of distress and adherence to healthcare screening reccomendations.
This leaves 375 participants included in the final analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (INSPIRE, Survivorship Care Plan) | Participants receive immediate access to the INSPIRE online program and personalized survivorship care plan. Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan Survey Administration: Ancillary studies |
| BG001 | Group II (Usual Care) | Participants receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Participants may receive access to the INSPIRE online program after 12 months. Best Practice and Internet site with links to existing resources: Receive usual care Survey Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | 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 |
| ||||||||||||||||||
| Cancer and Treatment Distress | The CTXD is a 22-item inventory of distress or worry related to stressful events for cancer survivors.The count of participants reported is the number of participants who reported distress or worry at baseline. | Count of Participants | Participants |
| |||||||||||||||||
| Healthcare Adherence (HCA) | The HCA is derived from the Cornell Service Index. Scores are transformed to proportion of HCA recommendations met. For primary outcomes, we use HCA items reflecting adherence to cardiometabolic surveillance (HCA-CM; 5 items). The count of participants reported is the number of participants that did not meet cardiovascular surveillance reccomendations at baseline. | Count of Participants | 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 | Cancer and Treatment Distress (CTXD) | Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of >=.90 was used to categorize participants as high in distress. Participants with scores <.90 were categorized as not distressed. | Group that met criterion for highly distressed | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Health Care Adherence (HCA)-Cardiometabolic | Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of <.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance. | Those impaired at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks | Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program. | Intervention participants who require telehealth stepped care at 6-weeks | Posted | Count of Participants | Participants | 6-weeks after enrollment. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Care Adherence (HCA)-Subsequent Malignancy Screening | Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. | Participants impaired at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PHQ-8 Depression | Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months | Participants impaired at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knowledge of Survivorship Needs and Health Related Self-efficacy | Mediators of primary outcomes: assessed by patient questionnaires. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Reach, Engagement and Fidelity of Web-based Intervention | Process Measures: Rates of participants approached versus registering, rates of visits to the web site, pages viewed, types of modalities used, attrition rates and support requests. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cost and Resources to Maintain Program | Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP. | Not Posted | 12 months | Participants |
1 year
This clinical trial is a behavioral intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (INSPIRE, Survivorship Care Plan) | Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. Internet, Mobile app and Telehealth Intervention: Receive INSPIRE and survivorship care plan Survey Administration: Ancillary studies | 3 | 184 | 0 | 184 | 0 | 184 |
| EG001 | Group II (Usual Care) | Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients may receive access to the INSPIRE online program after 12 months. Best Practice and Internet site with links to existing resources: Receive usual care Survey Administration: Ancillary studies | 1 | 191 | 0 | 191 | 0 | 191 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. K. Scott Baker | Fred Hutchinson Cancer Center | 206-667-5594 | ksbaker@fredhutch.org |
| Oct 29, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|