A Phase 1 interventional study of Project Onward website + social network and Project Onward website in Cancer, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.
Sponsored by Northwestern University · Phase 1, Interventional, and Treatment
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.
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 combine a variety of outreach methods, including telephone, email and an online social network, to increase adherence and promote the use of the website and the skills it teaches.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy.
Behavioral: Project Onward website
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.
Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Measured at baseline, 4 weeks, 8 weeks and 12 weeks
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
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Northwestern University