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

NCT01602211 | Completed Phase 3 DMC

• 3 other identifiers: 2605.00NCI-2012-00743R01CA160684
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer Survivor; Depression; Hematopoietic and Lymphoid Cell Neoplasm; Myelodysplastic Syndrome

Keywords

stem cell transplant; cancer survivors; internet; social media; distress; health care adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Health behaviors

  Up to 12 months

• 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

Study Arms (2)

Arm I (INSPIRE internet full program access)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (delayed program access control)

EXPERIMENTAL

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; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Internet-Based Intervention OTHER

Receive full access to INSPIRE

Arm I (INSPIRE internet full program access)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Arm II (delayed program access control)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (INSPIRE internet full program access); Arm II (delayed program access control)

Questionnaire Administration OTHER

Ancillary studies

Arm I (INSPIRE internet full program access); Arm II (delayed program access control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
• Currently 2-10 years after first HCT

You may not qualify if:

• 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)
• Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• Farhadfar N, Weaver MT, Al-Mansour Z, Yi JC, Jim HSL, Loren AW, Majhail NS, Whalen V, Uberti J, Wingard JR, Lynch Kelly D, Syrjala KL. Self-Efficacy for Symptom Management in Long-Term Adult Hematopoietic Stem Cell Survivors. Transplant Cell Ther. 2022 Sep;28(9):606.e1-606.e8. doi: 10.1016/j.jtct.2022.05.035. Epub 2022 May 31.

  PMID: 35662590 DERIVED

• Banerjee R, Yi JC, Majhail NS, Jim HSL, Uberti J, Whalen V, Loren AW, Syrjala KL. Driving Distance and Patient-Reported Outcomes in Hematopoietic Cell Transplantation Survivors. Biol Blood Marrow Transplant. 2020 Nov;26(11):2132-2138. doi: 10.1016/j.bbmt.2020.08.002. Epub 2020 Aug 8.

  PMID: 32781287 DERIVED

MeSH Terms

Conditions

Depression; Hematologic Neoplasms; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Karen Syrjala

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 18, 2012
• Study Start: May 14, 2013
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: July 31, 2020

Record last verified: 2017-09

Locations

US (6)