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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00743 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2605.00 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA160684 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies an internet and social-media program for improving quality of life in long-term survivors who underwent stem cell transplant. In this study, researchers want to compare a survivorship internet program to the standard treatment of currently available internet sites for transplant survivors to learn which works better for people who have received bone marrow or blood stem cell transplants. A survivorship-focused internet program may improve mood, stress, and preventive health care, and provide useful health resources for transplant survivors. It is not yet known whether currently available internet sites are more effective than a survivorship-focused internet program in improving quality of life in cancer survivors.
PRIMARY OBJECTIVES:
I. Determine whether 2-10 year hematopoietic cell transplant (HCT) survivors with elevated depression or cancer-related distress who are randomized to receive access to a tailored internet-based program report reduced depression and distress when compared with control group survivors who receive access to an internet site with links to transplant and cancer-specific online resources and delayed access to the internet site (active control).
II. Determine whether survivors with low survivorship preventive care adherence (PCA) who are randomized to receive access to the tailored internet-based program, including a survivorship preventive care plan, report increased PCA when compared with the active control group survivors.
SECONDARY OBJECTIVES:
I. Secondary outcomes will include process measures of internet study reach and utilization, as well as physical function, physical activity level, and knowledge of survivorship needs. Further analyses will identify risk factors for disparities in survivorship preventive care adherence in HCT survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Participants receive full access to the INSPIRE internet site comprising an individually tailored program with a greeting home page with links to each target area, a 'My Health Action Plan' health care guideline for transplant survivors, self-care tips and tool pages for each complication and major issues for HCT survivors, a section for each complication (mood, energy, heart health, strengthening bones, second cancers), resource pages, opportunities to send secure messages with questions or comments on any topic, opportunities to request additional assistance or information, mobile texting options, and social media links (Twitter/Facebook/Pinterest) maintained and monitored by the Social Media Specialist.
ARM II: Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (INSPIRE internet full program access) | Experimental | Participants receive full access to the INSPIRE internet site comprising an individually tailored program with a greeting home page with links to each target area, a 'My Health Action Plan' health care guideline for transplant survivors, self-care tips and tool pages for each complication and major issues for HCT survivors, a section for each complication (mood, energy, heart health, strengthening bones, second cancers), resource pages, opportunities to send secure messages with questions or comments on any topic, opportunities to request additional assistance or information, mobile texting options, and social media links (Twitter/Facebook/Pinterest) maintained and monitored by the Social Media Specialist. |
|
| Arm II (delayed program access control) | Experimental | Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Intervention | Other | Receive full access to INSPIRE |
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| Measure | Description | Time Frame |
|---|---|---|
| Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes | Up to 12 months | |
| PHQ-8 depression score as reported on the PCA, using binary outcomes | Up to 12 months | |
| Proportion of adherence to recommended survivorship preventive care and barriers to PCA | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health behaviors | Composite measure of health behaviors, including tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep. | Up to 12 months |
| Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Syrjala | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Wayne State University/Karmanos Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35662590 | Derived | Farhadfar N, Weaver MT, Al-Mansour Z, Yi JC, Jim HSL, Loren AW, Majhail NS, Whalen V, Uberti J, Wingard JR, Lynch Kelly D, Syrjala KL. Self-Efficacy for Symptom Management in Long-Term Adult Hematopoietic Stem Cell Survivors. Transplant Cell Ther. 2022 Sep;28(9):606.e1-606.e8. doi: 10.1016/j.jtct.2022.05.035. Epub 2022 May 31. | |
| 32781287 | Derived | Banerjee R, Yi JC, Majhail NS, Jim HSL, Uberti J, Whalen V, Loren AW, Syrjala KL. Driving Distance and Patient-Reported Outcomes in Hematopoietic Cell Transplantation Survivors. Biol Blood Marrow Transplant. 2020 Nov;26(11):2132-2138. doi: 10.1016/j.bbmt.2020.08.002. Epub 2020 Aug 8. |
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| Internet-Based Intervention | Other | Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site |
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| Medical Chart Review | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 12 months |
| Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire | This measure is a measure of leisure time physical activity. | Up to 12 months |
| Detroit |
| Michigan |
| 48201 |
| United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D003863 | Depression |
| D019337 | Hematologic Neoplasms |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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