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Completed

NCT Number: NCT03125070

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

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Loading trial locations.

About this study

OUTLINE:

Patients are randomized to 1 of 2 groups.

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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)
  • Does not complete baseline patient-reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
  • Non-proficient in English (written and spoken)

Treatment and study plan

Best Practice and Internet site with links to existing resources

Other

Receive usual care

Other names: best practice, standard of care, standard therapy

Internet, Mobile app and Telehealth Intervention

Other

Receive INSPIRE and survivorship care plan

Other names: Digital Intervention

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Cancer and Treatment Distress (CTXD)

    Time frame: Up to 12 months

    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.

  2. Health Care Adherence (HCA)-Cardiometabolic

    Time frame: Up to 12 months

    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.

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

    Time frame: 6-weeks after enrollment.

    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.

Secondary outcomes

  1. Health Care Adherence (HCA)-Subsequent Malignancy Screening

    Time frame: Up to 12 months

    Assesses adherence to subsequent malignancy surveillance in intervention participants vs. controls. Among those impaired at baseline, percent no longer impaired at 12 months.

  2. PHQ-8 Depression

    Time frame: Up to 12 months

    Assessed by participant questionnaire.Among those impaired (PHQ≥10) at baseline, percent no longer impaired at 12 months

Other outcomes

  1. Knowledge of Survivorship Needs and Health Related Self-efficacy

    Time frame: Up to 12 months

    Mediators of primary outcomes: assessed by patient questionnaires.

  2. Reach, Engagement and Fidelity of Web-based Intervention

    Time frame: Up to 12 months

    Process Measures: Rates of participants approached versus registering, rates of visits to the web site, pages viewed, types of modalities used, attrition rates and support requests.

  3. Cost and Resources to Maintain Program

    Time frame: 12 months

    Determine resources that would be needed to sustain the intervention as a national HCT survivorship program if implemented through the CIBMTR/NMDP.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

INSPIRE: A Multicenter Randomized Controlled Trial Integrating Health Informatics in a Scalable Stepped Care Self-Management Program for Survivors After Hematopoietic Cell Transplantation

Acronym: INSPIRE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2017
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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