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



Status:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Depression, Blood Cancer
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:2/1/2017
Start Date:May 14, 2013

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INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-Media Program for Long-Term Hematopoietic Cell Transplantation Survivors

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.

Inclusion Criteria:

- Received a transplant at a consortium center for a hematologic malignancy or
myelodysplasia

- Currently 2-10 years after first HCT

Exclusion Criteria:

- 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)
We found this trial at
6
sites
Philadelphia, Pennsylvania 19104
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Cleveland, OH
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Seattle, WA
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Tampa, Florida 33612
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Tampa, FL
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