- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04414436
A Guided Internet Intervention for Women Treated for Gynecological Cancer (GYNEA)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study's objectives and research questions Research questions
How did the participants use the program?
- What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
- Number of logins
- How much time did the participants spend on the program (per login )
- Number of modules completed, number of home-work and mindfulness assignment completed
- Type of errors made …
- What is the participants' perceived credibility of the program?
How do the participants experience the guided psychosocial digital intervention?
- How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
- How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
- How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
- Which factors do they describe as important for their satisfaction and dissatisfaction
- How is the perceived effect on the gynecological cancer survivors' competence, QoL, self-care and coping?
It is hypothesized that an internet-based psycho-social intervention will support women in developing self-competence and self-care which could be measured as increased QOL and secondarily affect the impact of cancer, distress, anxiety, depression, self-esteem, and self-reported ability to monitor and respond to symptoms of recurrence.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tine Nordgreen, PhD
- Telefonnummer: +4790094913
- E-mail: tine.nordgreen@gmail.com
Undersøgelse Kontakt Backup
- Navn: Ragnhild Sekse
Studiesteder
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Bergen, Norge, 5020
- Rekruttering
- Haukeland University Hospital
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Kontakt:
- Tine Nordgreen, PhD
- Telefonnummer: 90094913
- E-mail: tine.nordgreen@helse-bergen.no
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Vestland
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Bergen, Vestland, Norge, 5003
- Rekruttering
- Bergen Municipality Division School
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Kontakt:
- Britt Darlington, Advisor
- Telefonnummer: 53033443
- E-mail: britt.darlington@bergen.kommune.no
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
- have had gyneocological cancer
- maximum 1 year after gynecological cancer
Exclusion Criteria:
- severe medical or psychiatric condition
- relapse of gynecological cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: GYNEA- digital coping program
Participants randomized to this arm will receive active treatment after the inclusion
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6 modules with relevant information and tools for coping after cancer
Andre navne:
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Ingen indgriben: Waiting list
6 weeks waiting list before crossing over to GYNEA- digital coping program
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The Impact of Cancer version 2
Tidsramme: up to 26 weeks
|
Designed to assess the physical and psychosocial health experience of cancer survivors through its positive and negative impacts.
47-item questionnaire organized into 4 positive (altruism and empathy (AE), health awareness (HA), meaning of cancer (MOC), positive self-evaluation (PSE)) and 4 negative (appearance concerns (AC), body change concerns (BCC), life interference (LI) and worry (W)) impact dimensions [13] corresponding to the first 37 items.
The questionnaire also includes 10 additional items constituting conditional dimensions applicable to subsets of survivors assessing employment concerns (EC), relationship concerns for individuals with a partner (P), and relationship concerns for those without a partner (NP).
All items are scored on a five-point scale from 1 = strongly disagree to 5 = strongly agree.
A higher score on a dimension implies stronger endorsement of that content area
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up to 26 weeks
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The Quality of Life Patient/Cancer Survivor Version
Tidsramme: up to 26 weeks
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ordinal questionnaire measuring the quality of life in cancer patients over 42 items rated on 10 point Likert-type scale.
The revised instrument included 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.
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up to 26 weeks
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Patient Health Questionnaire
Tidsramme: up to 26 weeks
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Subjects indicated for each of the nine depressive symptoms (corresponding to the criteria ofDSM-IV) whether, during the previous 2 weeks, the symptom has bothered them: 0=not at all; 1=several days; 2=more than half of the days; 3=nearly every day.
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up to 26 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 9612
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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