Empowering Cancer Survivors Through Information Technology

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial of a web-based informational intervention (UMFollowUp) for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and psychosocial functioning.

Detailed Description
-----------------
Individuals randomly assigned to the control group will receive standard of care for the duration of their participation. This means they will continue to receive information regarding their diagnosis, treatments and ongoing health needs from their provider (no access to website). Individuals randomly assigned to the treatment group will receive access to UMFollowUp, a secure, HIPAA-compliant website. All participants will be asked to complete paper-and-pencil surveys at baseline and 9 months later to determine the impact of the web-based intervention.

Official Title
-----------------
Empowering Cancer Survivors Through Information Technology

Conditions
-----------------
Cancer Survivor

Intervention / Treatment
-----------------
* Behavioral: UMFollowUp
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of diagnosis of hematologic malignancy or malignant neoplasm, and in disease free remission at time of recruitment. Must be English-speaking and have access to a computer with internet access, and must have completed treatment at University of Minnesota Medical Center-Fairview for cancer. Exclusion Criteria: Individual with significant visual impairments and neurologic/cognitive difficulties which limit their ability to see and under our outcome questionnaires or website content will be excluded from participation.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 28 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Intervention<br>UMFollowUp - web-based internet resource for information about their diagnostic histories, recommendations for follow-up care, and tips to enhance their treatment, psychosocial and physical well-being. | Behavioral: UMFollowUp<br>* Web-based internet resource for self-reported treatment summaries and psychosocial and physical well-being.<br>|
| Active Comparator: Standard of Care<br>Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website. | Other: Standard of Care<br>* Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Knowledge Survey | Measure of patient reported knowledge of their cancer diagnosis, history and treatments. | Time of Enrollment and 9 Months Later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Questionnaire | A measure of quality of life. | Time of Enrollment and 9 Months Later | 
| Cancer Rehabilitation Evaluation System | Short Form (SF) Medical Interaction Subscale | Time of Enrollment and 9 Months Later | 
| Herth Hope Index | A measure of self-reported hope. | Time of Enrollment and 9 Months Later | 
| Multidimensional Scale of Perceived Social Support | A measure of self-reported social support. | Time of Enrollment and 9 Months Later | 
| Health Locus of Control Scale | A measure of self-reported locus of control. | Time of Enrollment and 9 Months Later | 
| State Trait Anxiety Inventory | A measure of self-reported anxiety. | Time of Enrollment and 9 Months Later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer survivor