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

Study Overview
=================
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
-----------------
* Other: Best Practice and Internet site with links to existing resources
* Other: Internet, Mobile app and Telehealth Intervention
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (INSPIRE, survivorship care plan)<br>Patients receive immediate access to the INSPIRE online program and personalized survivorship care plan. | Other: Internet, Mobile app and Telehealth Intervention<br>* Receive INSPIRE and survivorship care plan<br>* Other names: Digital Intervention;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (usual care)<br>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<br>* Receive usual care<br>* Other names: standard therapy;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer and Treatment Distress (CTXD) | Assesses distress or worry level. | Up to 12 months | 
| Health Care Adherence (HCA)-cardio | Assesses adherence to cardiometabolic surveillance. | Up to 12 months | 
| HCA-cancer | Assesses adherence to subsequent malignancy surveillance. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of web-based intervention | Rates of participants approached versus registering. | Up to 12 months | 
| Utilization of web-based intervention | Assessed by number of visits to the site, number of pages viewed, types of modalities used, attrition rates and support requests. | Up to 12 months | 
| PHQ-8 Depression | Assessed by patient questionnaire. | Up to 12 months | 
| PROMIS physical function | Assessed by patient questionnaire. | Up to 12 months | 
| Knowledge of survivorship needs | Assessed by patient questionnaire. | Up to 12 months |