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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01602211
First received: May 15, 2012
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cancer Survivor
Depression
Hematopoietic/Lymphoid Cancer
Other: internet-based intervention
Other: questionnaire administration
Other: quality-of-life assessment
Other: medical chart review
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • PHQ-8 depression score as reported on the PCA, using binary outcomes [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Proportion of adherence to recommended survivorship preventive care and barriers to PCA [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    This measure is a measure of leisure time physical activity.

  • Health behaviors [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Health behaviors include tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep.


Estimated Enrollment: 1600
Study Start Date: May 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (INSPIRE internet full program access)
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.
Other: internet-based intervention
Receive full access to INSPIRE
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (delayed program access control)
Participants receive annotated website links to existing transplant and cancer survivor sites, followed by delayed access to the INSPIRE internet program after 1 year.
Other: internet-based intervention
Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: medical chart review
Ancillary studies
Other Name: chart review

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602211

Locations
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Heather Jim    813-745-6369      
Principal Investigator: Claudio Anasetti         
Principal Investigator: Heather Jim         
United States, Michigan
Barbara Ann Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Joseph P. Uberti    313-576-8760      
Principal Investigator: Joseph P. Uberti         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Fausto Loberiza    402-559-5166      
Principal Investigator: Fausto Loberiza         
United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alison W. Loren    215-615-3138      
Principal Investigator: Alison W. Loren         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Karen L. Syrjala    206-667-4579      
Principal Investigator: Karen L. Syrjala         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Karen Syrjala Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01602211     History of Changes
Other Study ID Numbers: 2605.00, NCI-2012-00743, 2605.00, R01CA160684, P30CA015704
Study First Received: May 15, 2012
Last Updated: October 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
stem cell transplant
cancer survivors
internet
social media
distress
health care adherence

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 19, 2014