E-health Intervention for Cancer Survivors 2.0
|ClinicalTrials.gov Identifier: NCT01348997|
Recruitment Status : Withdrawn (Study ended prior to completion of planning stage. No participants enrolled.)
First Posted : May 6, 2011
Last Update Posted : October 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Project Onward website + 16 person social network Behavioral: Project Onward website + 8 person social network||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||E-Health Intervention for Cancer Survivors 2.0|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||November 2013|
|Active Comparator: Project Onward website + 16 person social network||
Behavioral: 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||
Behavioral: 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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348997
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||David C. Mohr, Ph.D.||Northwestern University|