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E-health Intervention for Cancer Survivors


Phase 1
19 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

E-health Intervention for Cancer Survivors


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.


Inclusion Criteria:



1. Any cancer diagnosis

2. Has completed treatment for cancer and is currently in full remission.

3. ECOG performance Status of < 3.

4. No history of hospitalization for psychiatric reasons with in the past 5 years.

5. Has a telephone, e-mail account, computer, and broadband access to the Internet.

6. Has familiarity with using the Internet that allows for adequate navigation of
website.

7. Is able to speak and read English.

8. Is at least 19 years of age.

9. Is able to give informed consent.

Exclusion Criteria:

1. Has hearing or voice impairment that would prevent participation in assessments or
coach treatment arm

2. Has visual impairment that would prevent use of the website and completion of
assessment materials.

3. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Depression, as measured by the Hospital Anxiety and Depression Scale (HADS)

Outcome Time Frame:

Measured at baseline, 4 weeks, 8 weeks and 12 weeks

Safety Issue:

No

Principal Investigator

David C. Mohr, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

STU00026896

NCT ID:

NCT01114802

Start Date:

April 2010

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • Cancer survivors
  • Anxiety
  • Depression
  • Technology Assisted
  • Internet

Name

Location

Northwestern University Chicago, Illinois  60611