E-health Intervention for Cancer Survivors

NCT01114802 | Completed Phase 1

• 1 other identifier: STU00026896
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and examine the effectiveness of an intervention that utilizes multiple telecommunications technologies to improve cancer survivors' access to mental health care and increase their ability to manage the high risk transition time from active cancer treatment to survivorship. The intervention, referred to as Project Onward, uses an interactive website, e-mail, telephone, 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.

Conditions

Cancer

Keywords

Cancer survivors; Anxiety; Depression; Technology Assisted; Internet

Outcome Measures

Primary Outcomes (1)

• Depression, 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 + social network

EXPERIMENTAL

This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.

Behavioral: Project Onward website + social network

Project Onward website

ACTIVE COMPARATOR

This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy.

Behavioral: Project Onward website

Interventions

Project Onward website + social network BEHAVIORAL

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 + social network

Project Onward website BEHAVIORAL

Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.

Project Onward website

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• No history of hospitalization for psychiatric reasons with in the past 5 years.
• 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 hearing or voice impairment that would prevent participation in assessments or coach treatment arm
• Has visual impairment that would prevent use of the website and completion of assessment materials.
• Diagnosis of basal or squamous cell skin cancers
• \) Has physical impairments that would limit use of the computer. 4) Meets criteria for dementia by scoring \< 25 on the Telephone Interview for Cognitive Status (TICS).
• \) Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of an internet intervention may be either inappropriate or dangerous, or has been hospitalized for psychiatric reasons within the past 5 years. Patients with substance abuse diagnoses who have been abstinent for 3 months will be admitted if otherwise eligible.
• \) Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study.
• \) Is planning to be out of town or unavailable for treatment for 2 weeks or more during the scheduled treatment time.
• \) Exhibits severe suicidality, including ideation, plan, and intent. 9) Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• David C. Mohr, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 19, 2014

Record last verified: 2013-06

Locations

US (1)