INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-media Program for Long-term Hematopoietic Cell Transplantation Survivors
18 Years
N/A
Both
Cancer Survivor, Depression, Hematopoietic/Lymphoid Cancer
Trial Information
INSPIRE for Survivorship After Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-media Program for Long-term Hematopoietic Cell Transplantation 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 a an
individually tailored program with a greeting home page with links to each target area,
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), a discussion board for input from other survivors, 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.
ARM II: Participants receive 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
- 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; (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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
PHQ-8 depression score as reported on the PCA, using binary outcomes
Outcome Time Frame:
Up to 12 months
Safety Issue:
No
Principal Investigator
Karen Syrjala
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Federal Government
Study ID:
2605.00
NCT ID:
NCT01602211
Start Date:
February 2013
Completion Date:
Related Keywords:
- Cancer Survivor
- Depression
- Hematopoietic/Lymphoid Cancer
- stem cell transplant cancer survivors internet social media distress health care adherence
- Depression
- Depressive Disorder
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
