Breast Cancer FemaleNCT05760755
Stick Together - Pilot Intervention Study
A study testing Stick Together in people with Breast Cancer Female, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Stick Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 6 Aug 2024
- 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 25 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
- living with a romantic partner
- living in romantic partnership with a patient eligible for the intervention
Who cannot join
- severe relationship difficulties or current couples counselling
- severe, untreated mental illness in one or both partners
- capable of participating (mastery of Danish language, available smartphone, tablet or other device, no cognitive impairment)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of breast surgery, Gentofte Hospital
Gentofte Municipality
About this study
Official title: Stick Together - a Dyadic Web-intervention for Younger Patients with Breast Cancer and Their Partners
This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.
Read the detailed description
This one-arm feasibility study pilots the 'Stick Together' intervention among 20 women newly diagnosed with breast cancer at age 25-49 and their cohabiting partners. The intervention aims to strengthen couples' positive dyadic coping and communication, as well as participants mental health and quality of life, as well as quality of life of underage children.
- Conditions
- Breast Cancer Female
- Being tested
- Stick Together
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stick TogetherBehavioural
The intervention consists of 12 online modules, completed flexibly during and immediately after primary cancer treatment. The intervention contains interviews with other couples, psychoeducational information, and interactive exercises on themes such as dyadic coping and communication, being diagnosed at a young age, fertility and children, and life after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Stick Together) | Experimental | Intervention group (all participants) Receives: Behavioral: Stick Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation (Acceptability 1)
Percentage of eligible participants consenting to participate
Measured: baseline
Participants satisfaction (Acceptability 2)
Percentage of participants satisfied with the intervention
Measured: Post-intervention follow-up (7-9 months post diagnosis)
Completion (Feasibility)
Percentage of participants completing the intervention (65% completion)
Measured: Post-intervention (7-9 months post diagnosis)
Secondary outcomes (16)
Change from baseline to post-intervention in supportive dyadic coping
Score on supportive dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in delegated dyadic coping
Score on delegated dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in negative dyadic coping
Score on negative dyadic coping (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in stress communication
Score on stress communication (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in satisfaction with dyadic coping
Score on satisfaction with dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in joint dyadic coping
Score on joint dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in perceived stress
Score on perceived stress (min 0, max 16), as measured by the Perceived Stress Scale. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in anxiety
Score on anxiety symptoms (min 0, max 21), as measured by the Generalized anxiety scale-7. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in depression
Score on depression symptoms (min 0, max 27), as measured by the Patient Health Questionnaire-9. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in protective buffering
Score on protective buffering (min 8, max 40), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in active engagement
Score on active engagement (min 5, max 25), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in overprotection
Score on overprotection (min 6, max 30), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in psychological quality of life
Score on psychological quality of life (min 0, max 100), as measured by the World Health Organization Quality of Life Brief Version subscale (WHOQOL-BREF). Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in physical quality of life
Score on physical quality of life (min 0, max 100), as measured by the World Health Organization Quality of Life Brief Version scubscale (WHOQOL-BREF). Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in social quality of life
Score on social quality of life (min 0, max 100), as measured by the World Health Organization Quality of Life Brief Version subscale (WHOQOL-BREF). Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in children's quality of life
Total mean score on quality of life (min 0, max 100), as measured by the Pediatric Quality of LIfe inventory (PEDSQL). Higher scores indicate better outcome.
Measured: Baseline, after intervention completion (average 8 months after diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2023
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Committee for Health Education, TrygFonden, Denmark, Sygekassernes Helsefond, Danish Cancer Society, University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Annika von Heymann, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760755
- Sponsor's protocol ID
- P-2020-246
- Other IDs
- H-22032044
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared upon reasonable request to the Principal Investigator, when it can be allowed by applicable law and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stick Together - a Dyadic Web-intervention for Younger Patients with Breast Cancer and Their Partners
- ClinicalTrials.gov ID
- NCT05760755
- Acronym / sponsor ID
- P-2020-246
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Committee for Health Education, TrygFonden, Denmark, Sygekassernes Helsefond, Danish Cancer Society, University Hospital, Gentofte, Copenhagen
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 8 Mar 2023 (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.
This pilot study investigates the acceptability and feasibility of 'Stick Together', a self-guided online intervention, for younger women with breast cancer and their cohabiting partners.
Detailed description
This one-arm feasibility study pilots the 'Stick Together' intervention among 20 women newly diagnosed with breast cancer at age 25-49 and their cohabiting partners. The intervention aims to strengthen couples' positive dyadic coping and communication, as well as participants mental health and quality of life, as well as quality of life of underage children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Stick Together) | Experimental | Behavioral: Stick TogetherIntervention group (all participants) |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
- living with a romantic partner
- living in romantic partnership with a patient eligible for the intervention
Key exclusion criteria (3 listed)
- severe relationship difficulties or current couples counselling
- severe, untreated mental illness in one or both partners
- capable of participating (mastery of Danish language, available smartphone, tablet or other device, no cognitive impairment)
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 |
|---|---|---|
| Stick TogetherThe intervention consists of 12 online modules, completed flexibly during and immediately after primary cancer treatment. The intervention contains interviews with other couples, psychoeducational information, and interactive exercises on themes such as dyadic coping and communication, being diagnosed at a young age, fertility and children, and life after treatment. | Behavioural | Intervention group (Stick Together) |
Primary outcome
Participation (Acceptability 1)
Time frame: baseline
Percentage of eligible participants consenting to participate
Participants satisfaction (Acceptability 2)
Time frame: Post-intervention follow-up (7-9 months post diagnosis)
Percentage of participants satisfied with the intervention
Completion (Feasibility)
Time frame: Post-intervention (7-9 months post diagnosis)
Percentage of participants completing the intervention (65% completion)
16 secondary outcomes
Change from baseline to post-intervention in supportive dyadic coping
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in delegated dyadic coping
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in negative dyadic coping
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in stress communication
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in satisfaction with dyadic coping
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in joint dyadic coping
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in perceived stress
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in anxiety
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in depression
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in protective buffering
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in active engagement
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in overprotection
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in psychological quality of life
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in physical quality of life
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in social quality of life
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Change from baseline to post-intervention in children's quality of life
Time frame: Baseline, after intervention completion (average 8 months after diagnosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Yes. IPD can be shared upon reasonable request to the Principal Investigator, when it can be allowed by applicable law and regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stick Together in people with Breast Cancer Female, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation (Acceptability 1) (time frame: baseline). 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 19 Nov 2024.