INSPIRE: Internet and Social-media Program With Information and Resources for Long-Term Cancer Survivors Who Underwent Stem Cell Transplant

Completed · Phase 3

Conditions studied: Cancer Survivor, Depression, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT01602211

Run by

Fred Hutchinson Cancer Center

People needed

1600

Starts

2013-05-14

Expected to finish

2016-11-28

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
• Currently 2-10 years after first HCT

You may not qualify if…

• Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored 'My Health Action Plan' health care guideline for transplant survivors also provided to randomized participants
• English insufficient to complete baseline patient-reported outcomes (PRO) assessments
• Has received treatment for a recurrent or 2nd cancer that required > surgical excision in the past 2 years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between 2-10 years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment)
• Scores 20 or above on the patient health questionnaire (PHQ)-8 depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (2% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
• Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
• Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
• Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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