Clinical trial NCT04414436: A Guided Internet Intervention for Women Treated for Gynecological Cancer
Official title: A Guided Internet Intervention for Women Treated for Gynecological Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: cancer
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: VID Specialized University
First posted: 2020-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The study's objectives and research questions Research questions

1. How did the participants use the program?

   1. What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
   2. Number of logins
   3. How much time did the participants spend on the program (per login )
   4. Number of modules completed, number of home-work and mindfulness assignment completed
   5. Type of errors made ...
2. What is the participants' perceived credibility of the program?
3. How do the participants experience the guided psychosocial digital intervention?

   1. How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
   2. How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
   3. How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
   4. Which factors do they describe as important for their satisfaction and dissatisfaction
4. 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.

Eligibility criteria: Inclusion Criteria

* have had gyneocological cancer
* maximum 1 year after gynecological cancer

Exclusion Criteria:

* severe medical or psychiatric condition
* relapse of gynecological cancer

Primary outcomes:
measure: The Impact of Cancer version 2
timeFrame: up to 26 weeks
measure: The Quality of Life Patient/Cancer Survivor Version
timeFrame: up to 26 weeks
measure: Patient Health Questionnaire
timeFrame: up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Municipality Division School
state: Vestland
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References: