A Guided Internet Intervention for Women Treated for Gynecological Cancer

Quality of Life Clinical Trial

— GYNEA  

Official title:

A Guided Internet Intervention for Women Treated for Gynecological Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414436
• Other study ID #: 9612
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Haukeland University Hospital
• Contact: Tine Nordgreen, PhD
• Phone: +4790094913
• Email: tine.nordgreen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria

• have had gyneocological cancer

• maximum 1 year after gynecological cancer

Exclusion Criteria:

• severe medical or psychiatric condition

• relapse of gynecological cancer

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• GYNEA- digital coping program for women after gynaecological cancer
6 modules with relevant information and tools for coping after cancer

Locations

Country	Name	City	State
Norway	Bergen Municipality Division School	Bergen	Vestland
Norway	Haukeland University Hospital	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen, VID Specialized University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Impact of Cancer version 2	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	up to 26 weeks
Primary	The Quality of Life Patient/Cancer Survivor Version	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.	up to 26 weeks
Primary	Patient Health Questionnaire	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.	up to 26 weeks