NCT01348997

Brief Summary

This study will develop and examine the effectiveness of an intervention that utilizes technology to improve cancer survivors' access to mental health care and increase their ability to manage the stressors involved in cancer survivorship. The intervention, referred to as Project Onward, uses an interactive website and an online social network. The purpose of this study is to pilot a novel intervention that can reduce costs, examine methods to improve adherence to internet based treatment and overcome numerous barriers to treatment for mental health concerns.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

May 4, 2011

Last Update Submit

October 6, 2014

Conditions

Keywords

cancercancer survivorsinternetdepressionanxiety

Outcome Measures

Primary Outcomes (2)

  • Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)

    Measured at baseline, 4 weeks, 8 weeks and 12 weeks

  • Anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS)

    Measured at baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (1)

  • Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed)

    From baseline through 12 weeks

Study Arms (2)

Project Onward website + 16 person social network

ACTIVE COMPARATOR
Behavioral: Project Onward website + 16 person social network

Project Onward website + 8 person social network

ACTIVE COMPARATOR
Behavioral: Project Onward website + 8 person social network

Interventions

The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 16 other cancer survivors.

Project Onward website + 16 person social network

The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.

Project Onward website + 8 person social network

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any cancer diagnosis.
  • Has completed treatment for cancer and is currently in full remission.
  • ECOG performance Status of \< 3.
  • Has a telephone, e-mail account, computer, and broadband access to the Internet.
  • Has familiarity with using the Internet that allows for adequate navigation of website.
  • Is able to speak and read English.
  • Is at least 19 years of age.
  • Is able to give informed consent.

You may not qualify if:

  • Has visual impairment that would prevent use of the website and completion of assessment materials.
  • Diagnosis of basal or squamous cell skin cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • David C. Mohr, Ph.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations