NCT04414436

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

May 26, 2020

Last Update Submit

August 24, 2021

Conditions

Quality of Life

Keywords

cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

GYNEA- digital coping program

EXPERIMENTAL

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

Behavioral: GYNEA- digital coping program for women after gynaecological cancer

Waiting list

NO INTERVENTION

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

Interventions

GYNEA- digital coping program for women after gynaecological cancerBEHAVIORAL

6 modules with relevant information and tools for coping after cancer

Also known as: waiting list
GYNEA- digital coping program

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgyneocological cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • severe medical or psychiatric condition
  • relapse of gynecological cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bergen Municipality Division School

Bergen, Vestland, 5003, Norway

RECRUITING

Haukeland University Hospital

Bergen, 5020, Norway

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Central Study Contacts

Tine Nordgreen, PhD

CONTACT

+4790094913tine.nordgreen@gmail.com

Ragnhild Sekse

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
study participants will be identified with an anonymous ID
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

February 25, 2021

Primary Completion

December 1, 2021

Study Completion

December 31, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

NO(2)