Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Empowering Cancer Survivors Through Information Technology

This study has been terminated.
(Funding unavailable.)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01593618
First received: May 4, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cancer Survivor
Behavioral: UMFollowUp
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Empowering Cancer Survivors Through Information Technology

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Cancer Knowledge Survey [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    Measure of patient reported knowledge of their cancer diagnosis, history and treatments.


Secondary Outcome Measures:
  • SF-36 Questionnaire [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    A measure of quality of life.

  • Cancer Rehabilitation Evaluation System [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    Short Form (SF) Medical Interaction Subscale

  • Herth Hope Index [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    A measure of self-reported hope.

  • Multidimensional Scale of Perceived Social Support [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    A measure of self-reported social support.

  • Health Locus of Control Scale [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    A measure of self-reported locus of control.

  • State Trait Anxiety Inventory [ Time Frame: Time of Enrollment and 9 Months Later ] [ Designated as safety issue: No ]
    A measure of self-reported anxiety.


Enrollment: 53
Study Start Date: August 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Web-Based Intervention
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
Web-based internet resource for self-reported treatment summaries and psychosocial and physical well-being.
Active Comparator: Standard of Care
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
Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593618

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Alicia Kunin-Batson, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01593618     History of Changes
Other Study ID Numbers: 2007NT078
Study First Received: May 4, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
cancer survivor

ClinicalTrials.gov processed this record on November 27, 2014