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E-health Intervention for Cancer Survivors (Onward)

18. marts 2014 opdateret af: David Mohr, Northwestern University

Project Onward: an Innovative E-health Intervention for Cancer Survivors

This study will develop and examine the effectiveness of an intervention that utilizes multiple telecommunications technologies to improve cancer survivors' access to mental health care and increase their ability to manage the high risk transition time from active cancer treatment to survivorship. The intervention, referred to as Project Onward, uses an interactive website, e-mail, telephone, 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Project Onward website + 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.
Aktiv komparator: Project Onward website
This arm has the website which includes 8 weeks of Internet-based cognitive behavioral therapy.
Adfærdsmæssigt: Project Onward website
Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Depression, målt ved Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Målt ved baseline, 4 uger, 8 uger og 12 uger
Målt ved baseline, 4 uger, 8 uger og 12 uger

Sekundære resultatmål

Resultatmål
Tidsramme
Brug af webstedet (f.eks. antal logins, gennemsnitlig besøgslængde, samlet tid brugt på webstedet, antal gennemførte øvelser)
Tidsramme: Fra baseline til 12 uger
Fra baseline til 12 uger

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Efterforskere

  • Ledende efterforsker: David C. Mohr, Ph.D., Northwestern University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2010

Primær færdiggørelse (Faktiske)

1. april 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

29. april 2010

Først indsendt, der opfyldte QC-kriterier

30. april 2010

Først opslået (Skøn)

3. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2014

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STU00026896

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Project Onward website + social network

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner