E-health Intervention for Cancer Survivors (Onward)
Project Onward: an Innovative E-health Intervention for Cancer Survivors
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Depresjon, målt ved Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Målt ved baseline, 4 uker, 8 uker og 12 uker
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Målt ved baseline, 4 uker, 8 uker og 12 uker
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Bruk av nettstedet (f.eks. antall pålogginger, gjennomsnittlig besøkslengde, total tid brukt på nettstedet, antall fullførte øvelser)
Tidsramme: Fra baseline til 12 uker
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Fra baseline til 12 uker
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: David C. Mohr, Ph.D., Northwestern University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STU00026896
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Project Onward website + social network
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Northwestern UniversityTilbaketrukket
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University Hospital, Strasbourg, FranceFullførtFolsyremangel | Eldre pasienter | Sosial isoleringFrankrike