Stick Together - Pilot Intervention Study

November 15, 2024 updated by: Annika von Heymann, Rigshospitalet, Denmark

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark
        • Department of breast surgery, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (patients):

  • women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
  • living with a romantic partner

Inclusion Criteria (partners):

  • living in romantic partnership with a patient eligible for the intervention

Exclusion Criteria (both patients and partners):

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (Stick Together)
Intervention group (all participants)
Behavioral: Stick Together
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participation (Acceptability 1)
Time Frame: baseline
Percentage of eligible participants consenting to participate
baseline
Participants satisfaction (Acceptability 2)
Time Frame: Post-intervention follow-up (7-9 months post diagnosis)
Percentage of participants satisfied with the intervention
Post-intervention follow-up (7-9 months post diagnosis)
Completion (Feasibility)
Time Frame: Post-intervention (7-9 months post diagnosis)
Percentage of participants completing the intervention (65% completion)
Post-intervention (7-9 months post diagnosis)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to post-intervention in supportive dyadic coping
Time Frame: Baseline, after intervention completion (average 8 months after diagnosis)
Score on supportive dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
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)
Score on delegated dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
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)
Score on negative dyadic coping (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate worse outcome.
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)
Score on stress communication (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
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)
Score on satisfaction with dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
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)
Score on joint dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
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)
Score on perceived stress (min 0, max 16), as measured by the Perceived Stress Scale. Higher scores indicate worse outcome.
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)
Score on anxiety symptoms (min 0, max 21), as measured by the Generalized anxiety scale-7. Higher scores indicate worse outcome.
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)
Score on depression symptoms (min 0, max 27), as measured by the Patient Health Questionnaire-9. Higher scores indicate worse outcome.
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)
Score on protective buffering (min 8, max 40), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
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)
Score on active engagement (min 5, max 25), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate better outcome.
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)
Score on overprotection (min 6, max 30), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
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)
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.
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)
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.
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)
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.
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)
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.
Baseline, after intervention completion (average 8 months after diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danish Cancer Society
TrygFonden, Denmark
University Hospital, Gentofte, Copenhagen
Sygekassernes Helsefond
Danish Committee for Health Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P-2020-246
  • H-22032044 (Other Identifier: Videnskabsetisk Komité (RegionH))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD can be shared upon reasonable request to the Principal Investigator, when it can be allowed by applicable law and regulations.

IPD Sharing Time Frame

Upon completion of study and publication of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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