- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114802
E-health Intervention for Cancer Survivors (Onward)
Project Onward: an Innovative E-health Intervention for Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
3) 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).
5) 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.
6) Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 8-week treatment phase of the study.
7) Is planning to be out of town or unavailable for treatment for 2 weeks or more during the scheduled treatment time.
8) 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Project Onward website + social network
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.
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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.
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Active Comparator: Project Onward website
This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy.
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Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Measured at baseline, 4 weeks, 8 weeks and 12 weeks
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Measured at baseline, 4 weeks, 8 weeks and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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From baseline through 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David C. Mohr, Ph.D., Northwestern University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00026896
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Project Onward website + social network
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Medical College of WisconsinNational Institute on Drug Abuse (NIDA)CompletedSexually Transmitted Diseases | HIVEl Salvador
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Massachusetts General HospitalMbarara University of Science and TechnologyUnknown
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Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedOverweight and ObesityUnited States
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Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV InfectionsBulgaria, Hungary, Russian Federation
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Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV | AIDSUnited States, Russian Federation
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Florida State UniversityNational Institute of Mental Health (NIMH)CompletedAutistic DisorderUnited States
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Lisa DixonWithdrawnSchizophrenia | First Episode PsychosisUnited States