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

Depression Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602211
• Other study ID #: 2605.00
• Secondary ID: NCI-2012-0074326
• Status: Completed
• Phase: Phase 3
• Start date: May 14, 2013
• Est. completion date: November 28, 2016

Study information

• Verified date: September 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: November 28, 2016
• Est. primary completion date: November 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivor
• Depression
• Hematopoietic and Lymphoid Cell Neoplasm
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Intervention

Other:
• Internet-Based Intervention
Receive full access to INSPIRE
• Internet-Based Intervention
Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site
• Medical Chart Review
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes		Up to 12 months
Primary	PHQ-8 depression score as reported on the PCA, using binary outcomes		Up to 12 months
Primary	Proportion of adherence to recommended survivorship preventive care and barriers to PCA		Up to 12 months
Secondary	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
Secondary	Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale		Up to 12 months
Secondary	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