NCT01593618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

4.7 years

First QC Date

May 4, 2012

Last Update Submit

November 29, 2017

Conditions

Keywords

cancer survivor

Outcome Measures

Primary Outcomes (1)

  • Cancer Knowledge Survey

    Measure of patient reported knowledge of their cancer diagnosis, history and treatments.

    Time of Enrollment and 9 Months Later

Secondary Outcomes (6)

  • SF-36 Questionnaire

    Time of Enrollment and 9 Months Later

  • Cancer Rehabilitation Evaluation System

    Time of Enrollment and 9 Months Later

  • Herth Hope Index

    Time of Enrollment and 9 Months Later

  • Multidimensional Scale of Perceived Social Support

    Time of Enrollment and 9 Months Later

  • Health Locus of Control Scale

    Time of Enrollment and 9 Months Later

  • +1 more secondary outcomes

Study Arms (2)

Web-Based Intervention

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

UMFollowUpBEHAVIORAL

Web-based internet resource for self-reported treatment summaries and psychosocial and physical well-being.

Web-Based Intervention

Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website.

Standard of Care

Eligibility Criteria

Age15 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alicia Kunin-Batson, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

August 1, 2007

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations