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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01602211

Collaborator

National Cancer Institute (NCI) (NIH)

1,600

Enrollment

Locations

Arms

42.5

Actual Duration (Months)

266.7

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivor Depression Hematopoietic and Lymphoid Cell Neoplasm Myelodysplastic Syndrome	Other: Internet-Based Intervention Other: Internet-Based Intervention Other: Medical Chart Review Other: Quality-of-Life Assessment Other: Questionnaire Administration	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

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).
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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Actual Study Start Date :

May 14, 2013

Actual Primary Completion Date :

Nov 28, 2016

Actual Study Completion Date :

Nov 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
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: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies
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: Medical Chart Review Ancillary studies Other Names: Chart Review Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies

Arm

Intervention/Treatment

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: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

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: Medical Chart Review

Ancillary studies

Other Names:

Chart Review

Other: Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

Cancer and treatment distress (CTXD) score as reported on the PCA using binary outcomes [Up to 12 months]
PHQ-8 depression score as reported on the PCA, using binary outcomes [Up to 12 months]
Proportion of adherence to recommended survivorship preventive care and barriers to PCA [Up to 12 months]

Secondary Outcome Measures

Health behaviors [Up to 12 months]
Composite measure of health behaviors, including tobacco use, alcohol use, physical activity, use of sunscreen, food intake, body mass index, and sleep.
Physical function, as assessed by the Patient Reported Outcomes Measurement Information System scale [Up to 12 months]
Total minutes per week of moderate to vigorous intensity exercise as assessed by the Godin Leisure Time Exercise Questionnaire [Up to 12 months]
This measure is a measure of leisure time physical activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
3	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
4	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195
5	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
6	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109