Quality of LifeGYNEANCT04414436
A Guided Internet Intervention for Women Treated for Gynecological Cancer
A study testing GYNEA- digital coping program for women after gynaecological cancer in people with Quality of Life, run by Haukeland University Hospital at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- GYNEA- digital coping program for women after gynaecological cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNorway
- Study dates
- 25 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have had gyneocological cancer
- maximum 1 year after gynecological cancer
Who cannot join
- severe medical or psychiatric condition
- relapse of gynecological cancer
Trial locations and contacts
2 sites in 1 country.
Ragnhild Sekse contact
Norway2 sites, 2 recruiting
- Recruiting
Bergen Municipality Division School
Bergen, Vestland, 5003
Britt Darlington, Advisor, 53033443, britt.darlington@bergen.kommune.no
- Recruiting
Haukeland University Hospital
Bergen, 5020
Tine Nordgreen, PhD, 90094913, tine.nordgreen@helse-bergen.no
About this study
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.
Read the detailed description
The study's objectives and research questions Research questions
- How did the participants use the program?
- What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
- Number of logins
- How much time did the participants spend on the program (per login )
- Number of modules completed, number of home-work and mindfulness assignment completed
- Type of errors made …
- What is the participants' perceived credibility of the program?
- How do the participants experience the guided psychosocial digital intervention?
- How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
- How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
- How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
- Which factors do they describe as important for their satisfaction and dissatisfaction
- 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
- Quality of Life
- Being tested
- GYNEA- digital coping program for women after gynaecological cancer
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYNEA- digital coping program for women after gynaecological cancerBehavioural
Also called waiting list
6 modules with relevant information and tools for coping after cancer
| Study group | Role | What they receive |
|---|---|---|
| GYNEA- digital coping program | Experimental | Participants randomized to this arm will receive active treatment after the inclusion Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start25 Feb 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, VID Specialized University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414436
- Sponsor's protocol ID
- 9612
- Acronym
- GYNEA
- Status last verified
- Aug 2021
- First submitted
- 26 May 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Internet Intervention for Women Treated for Gynecological Cancer
- ClinicalTrials.gov ID
- NCT04414436
- Acronym / sponsor ID
- GYNEA / 9612
- Conditions
- Quality of Life
- Keywords
- cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, VID Specialized University
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- How did the participants use the program?
- What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
- Number of logins
- How much time did the participants spend on the program (per login )
- Number of modules completed, number of home-work and mindfulness assignment completed
- Type of errors made …
- What is the participants' perceived credibility of the program?
- How do the participants experience the guided psychosocial digital intervention?
- How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
- How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
- How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
- Which factors do they describe as important for their satisfaction and dissatisfaction
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- active intervention group vs waiting list group. Waitling list group crossing over to active group after 6 weeks
| Arm | Type | Receives |
|---|---|---|
| GYNEA- digital coping program | Experimental | Behavioral: GYNEA- digital coping program for women after gynaecological cancerParticipants randomized to this arm will receive active treatment after the inclusion |
| Waiting list | No intervention | –6 weeks waiting list before crossing over to GYNEA- digital coping program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have had gyneocological cancer
- maximum 1 year after gynecological cancer
Key exclusion criteria (2 listed)
- severe medical or psychiatric condition
- relapse of gynecological cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GYNEA- digital coping program for women after gynaecological cancerAlso: waiting list6 modules with relevant information and tools for coping after cancer | Behavioural | GYNEA- digital coping program |
Primary outcome
The Impact of Cancer version 2
Time frame: up to 26 weeks
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
The Quality of Life Patient/Cancer Survivor Version
Time frame: up to 26 weeks
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.
Patient Health Questionnaire
Time frame: up to 26 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnhild Sekse contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GYNEA- digital coping program for women after gynaecological cancer in people with Quality of Life, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tine Nordgreen, PhD (+4790094913, tine.nordgreen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Impact of Cancer version 2 (time frame: up to 26 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.