A Guided Internet Intervention for Women Treated for Gynecological Cancer

NCT ID: NCT04414436

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
study participants will be identified with an anonymous ID

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GYNEA- digital coping program

Participants randomized to this arm will receive active treatment after the inclusion

Group Type EXPERIMENTAL

GYNEA- digital coping program for women after gynaecological cancer

Intervention Type BEHAVIORAL

6 modules with relevant information and tools for coping after cancer

Waiting list

6 weeks waiting list before crossing over to GYNEA- digital coping program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GYNEA- digital coping program for women after gynaecological cancer

6 modules with relevant information and tools for coping after cancer

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

waiting list

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* severe medical or psychiatric condition
* relapse of gynecological cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bergen

OTHER

Sponsor Role collaborator

VID Specialized University

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bergen Municipality Division School

Bergen, Vestland, Norway

Site Status RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tine Nordgreen, PhD

Role: CONTACT

+4790094913

Ragnhild Sekse

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Britt Darlington, Advisor

Role: primary

Tine Nordgreen, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9612

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.