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NCT04414436: GYNEA

A Guided Internet Intervention for Women Treated for Gynecological Cancer

Status unknown NA Last updated 25 August 2021
What this trial tests

NA trial testing GYNEA- digital coping program for women after gynaecological cancer in Quality of Life in 100 participants. Status unknown.

Timeline
25 February 2021
Primary endpoint
1 December 2021
31 December 2021

Quick facts

Lead sponsorHaukeland University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposesupportive care
Enrollment100
Start date25 February 2021
Primary completion1 December 2021
Estimated completion31 December 2021
Sites2 locations across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Haukeland University Hospital

Who can join

Adults 18 to 80, female only, with Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gynecological cancers are the sixth most common cancer forms and the number of survivors is increasing as a consequence of more efficient treatment and longer life span. As part of regulary care after cancer treatment the women have five years of follow-up with the primary focus on recurrence, aiming to increase survival. However, several studies have shown that there is no evidence for this assumption on increased survival (ref). There are now suggested alternative perspectives in the follow up period targeting late effects, health-related quality of life (QoL) and patient satisfaction with care.The main aim of the current study is to test the feasibility and acceptability of an internet-based psychosocial intervention for women treated with curative intent gynecological cancer. Another aim is to test the perceived effect on gynecological cancer survivors health-related self-care and QoL.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Digital therapeutics in the clinic.
    Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536
  2. In Case of an Emergency: The Development and Effects of a Digital Intervention for Coping With Distress in Norway During the COVID-19 Pandemic.
    Nordgreen T, Nordby ES, Myklebost SB, Flobak E, et al · · 2021 · cited 3× · PMID 34880803 · DOI 10.3389/fpsyg.2021.705383

Verify or expand the search:

Other recruiting trials for Quality of Life

Currently open trials in the same condition.

Other Haukeland University Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04414436.

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