CancerPhase 1NCT01348997
E-health Intervention for Cancer Survivors 2.0
A Phase 1 study testing Project Onward website + 16 person social network and Project Onward website + 8 person social network in people with Cancer, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Project Onward website + 16 person social network and Project Onward website + 8 person social network
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has visual impairment that would prevent use of the website and completion of assessment materials.
- Diagnosis of basal or squamous cell skin cancers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-Health Intervention for Cancer Survivors 2.0
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.
Read the 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 use an online social network, to increase adherence and promote the use of the website and the skills it teaches.
- Conditions
- Cancer
- Being tested
- Project Onward website + 16 person social network, Project Onward website + 8 person social network
- Keywords
- cancer, cancer survivors, internet, depression, anxiety
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Onward website + 16 person social networkBehavioural
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.
Project Onward website + 8 person social networkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Project Onward website + 16 person social network | Active comparator | Not described Receives: Behavioral: Project Onward website + 16 person social network |
| Project Onward website + 8 person social network | Active comparator | Not described Receives: Behavioral: Project Onward website + 8 person social network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: Measured at baseline, 4 weeks, 8 weeks and 12 weeks
Anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: 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)
Measured: From baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
Why it stopped: Study ended prior to completion of planning stage. No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C. Mohr, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348997
- Sponsor's protocol ID
- NU Lurie 10CC01
- Status last verified
- Oct 2014
- First submitted
- 4 May 2011
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Health Intervention for Cancer Survivors 2.0
- ClinicalTrials.gov ID
- NCT01348997
- Acronym / sponsor ID
- NU Lurie 10CC01
- Conditions
- Cancer
- Keywords
- cancer, cancer survivors, internet, depression, anxiety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study ended prior to completion of planning stage. No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 use an online social network, to increase adherence and promote the use of the website and the skills it teaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Onward website + 16 person social network | Active comparator | Behavioral: Project Onward website + 16 person social network |
| Project Onward website + 8 person social network | Active comparator | Behavioral: Project Onward website + 8 person social network |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Has visual impairment that would prevent use of the website and completion of assessment materials.
- Diagnosis of basal or squamous cell skin cancers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project Onward website + 16 person social networkThe 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. | Behavioural | Project Onward website + 16 person social network |
| Project Onward website + 8 person social networkThe 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. | Behavioural | Project Onward website + 8 person social network |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Mohr, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Project Onward website + 16 person social network and Project Onward website + 8 person social network in people with Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, as measured by the Hospital Anxiety and Depression Scale (HADS) (time frame: Measured at baseline, 4 weeks, 8 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.