Self-Management Program and Survivorship Care Plan in Improving the Health of Cancer Survivors After Stem Cell Transplant

NCT03125070 | Completed Phase 3 Results DMC

• 4 other identifiers: 9819NCI-2017-00583R01CA215134RG1001537
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 15

Brief Summary

This phase III trial investigates health informatics and a self-management program for improving the health of cancer survivors after stem cell transplant. After transplant many survivors may feel stressed or may be unsure of what health care they need. A self-management program called "INSPIRE," along with a personalized survivorship care plan may improve stress and health care for transplant survivors.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (3)

• Cancer and Treatment Distress (CTXD)

  Among those impaired at baseline, percent who are no longer impaired at 12 months (among those not missing either). Scores range from 0-3 and higher scores indicate higher distress. A cutoff of \>=.90 was used to categorize participants as high in distress. Participants with scores \<.90 were categorized as not distressed.

  Up to 12 months

• Health Care Adherence (HCA)-Cardiometabolic

  Assesses adherence to cardiometabolic surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months. Scores range from 0-1. Higher scores indicate high adherence. A cutoff of \<.80 was used to categorize participants as low in adherence. Scores higher than .80 were classified as being adherent to cardiometabolic surveillance.

  Up to 12 months

• Characteristics of Intervention Participants Who Require Telehealth Stepped Care at 6-weeks

  Determine characteristics of participants who 1) do not meet criteria for adequate knowledge of cardiometabolic risks, or 2) do not report improved distress, or 3) have not logged in to the online program.

  6-weeks after enrollment.

Secondary Outcomes (2)

• Health Care Adherence (HCA)-Subsequent Malignancy Screening

  Up to 12 months

• PHQ-8 Depression

  Up to 12 months

Other Outcomes (3)

• Knowledge of Survivorship Needs and Health Related Self-efficacy

  Up to 12 months

• Reach, Engagement and Fidelity of Web-based Intervention

  Up to 12 months

• Cost and Resources to Maintain Program

  12 months

Study Arms (2)

Group I (INSPIRE, survivorship care plan)

EXPERIMENTAL

Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan.

Other: Internet, Mobile app and Telehealth Intervention; Other: Survey Administration

Group II (usual care)

ACTIVE COMPARATOR

Patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. Patients may receive access to the INSPIRE online program after 12 months.

Other: Best Practice and Internet site with links to existing resources; Other: Survey Administration

Interventions

Best Practice and Internet site with links to existing resources OTHER

Receive usual care

Also known as: best practice, standard of care, standard therapy

Group II (usual care)

Internet, Mobile app and Telehealth Intervention OTHER

Receive INSPIRE and survivorship care plan

Also known as: Digital Intervention

Group I (INSPIRE, survivorship care plan)

Survey Administration OTHER

Ancillary studies

Group I (INSPIRE, survivorship care plan); Group II (usual care)

Eligibility Criteria

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

You may qualify if:

• Received \>= 1 autologous or allogeneic (related or unrelated) HCT with curative intent at a participating transplant center for a hematologic malignancy
• Age 18 years of age or older at last transplant
• Survival 2-5 years after last HCT when first approached for enrollment
• In remission at time of study entry, may be receiving chemoprevention
• Internet and email access
• American and Canadian citizens, and/or those with mailing addresses in the United States (US)/Canada and/or temporarily residing anywhere outside the country (IE - military).

You may not qualify if:

• Development of invasive subsequent malignancy after HCT other than non-melanoma skin cancer, in the past two years
• Medical or other issue prohibiting computer use, reading or ability to comply with all study procedures or unable to communicate via phone (e.g., significant vision, hearing or cognitive impairment, major illness, hospitalization)
• 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)
• Non-proficient in English (written and spoken)

Sponsors & Collaborators

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

Study Sites (15)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

National Marrow Donor Program

Minneapolis, Minnesota, 55401, United States

Location

Center for International Blood and Marrow Transplant Research

Minneapolis, Minnesota, 55413-5000, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Oncology at Baylor Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr. K. Scott Baker
• Organization: Fred Hutchinson Cancer Center

ksbaker@fredhutch.org

206-667-5594

Study Officials

• K. Scott Baker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: October 29, 2020
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)