Overview

This trial is active, not recruiting.

Condition cancer
Treatments project onward website + 16 person social network, project onward website + 8 person social network
Phase phase 1
Sponsor Northwestern University
Start date May 2011
End date October 2013
Trial size 100 participants
Trial identifier NCT01348997, NU Lurie 10CC01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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 16 other cancer survivors.
(Active Comparator)
project onward website + 8 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.

Primary Outcomes

Measure
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
time frame: Measured at baseline, 4 weeks, 8 weeks and 12 weeks
Anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS)
time frame: Measured at baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes

Measure
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed)
time frame: From baseline through 12 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - Has visual impairment that would prevent use of the website and completion of assessment materials. - Diagnosis of basal or squamous cell skin cancers.

Additional Information

Official title E-Health Intervention for Cancer Survivors 2.0
Principal investigator David C. Mohr, Ph.D.
Description Nearly 65% of those with cancer diagnoses will survive for at least 5 years, with approximately 10.5 million cancer survivors in the United States. The time of transition for cancer patients, from active treatment to survivorship, has been identified as a time of high risk for depression and anxiety. Cancer survivors experience higher rates of anxiety and depression than those without a cancer history. Research has identified fear of recurrence, perceived loss of support, and social pressure to resume a "normal" life, among other phenomena, as sources for this emotional distress. However, only about 20% of all patients referred for psychotherapy ever enter treatment and of those who initiate treatment, nearly half drop out before completion. This suggests that there are significant barriers to receiving care. These barriers may be even higher for cancer survivors struggling with issues related to re-entry, such as returning to work, resuming household responsibilities and managing residual symptoms such as fatigue or pain. The internet promises to provide inexpensive access to treatment at any time of the day or night. Unfortunately, the potential for internet delivered services has not been realized. Studies examining treatments that simply provide access to an internet site commonly result in very high dropout after the first site visit, and typically little or no improvement target symptoms. A variety of methods to improve responses to internet interventions have been examined. In general, e-mail support improves adherence and telephone support can improve adherence even more. Another type of support that has only begun to be investigated is the use of social networks to help maintain adherence. This intervention will use an online social network, to increase adherence and promote the use of the website and the skills it teaches.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Northwestern University.