Back to resultsStick Together - Pilot Intervention Study
Primary Purpose
Breast Cancer Female
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Stick Together
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Female
Eligibility Criteria
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)
Sites / Locations
- Department of breast surgery, Gentofte Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group (Stick Together)
Arm Description
Intervention group (all participants)
Outcomes
Primary Outcome Measures
Participation (Acceptability 1)
Percentage of eligible participants consenting to participate
Participants satisfaction (Acceptability 2)
Percentage of participants satisfied with the intervention
Completion (Feasibility)
Percentage of participants completing the intervention (65% completion)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05760755
First Posted
January 26, 2023
Last Updated
March 6, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Committee for Health Education, TrygFonden, Denmark, Sygekassernes Helsefond, Danish Cancer Society, University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT05760755
Brief Title
Stick Together - Pilot Intervention Study
Official Title
Stick Together - A Dyadic Web-intervention for Younger Patients With Breast Cancer and Their Partners
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Committee for Health Education, TrygFonden, Denmark, Sygekassernes Helsefond, Danish Cancer Society, University Hospital, Gentofte, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (Stick Together)
Arm Type
Experimental
Arm Description
Intervention group (all participants)
Intervention Type
Behavioral
Intervention Name(s)
Stick Together
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation (Acceptability 1)
Description
Percentage of eligible participants consenting to participate
Time Frame
baseline
Title
Participants satisfaction (Acceptability 2)
Description
Percentage of participants satisfied with the intervention
Time Frame
Post-intervention follow-up (7-9 months post diagnosis)
Title
Completion (Feasibility)
Description
Percentage of participants completing the intervention (65% completion)
Time Frame
Post-intervention (7-9 months post diagnosis)
Secondary Outcome Measure Information:
Title
Change from baseline to post-intervention in supportive dyadic coping
Description
Score on supportive dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in delegated dyadic coping
Description
Score on delegated dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in negative dyadic coping
Description
Score on negative dyadic coping (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in stress communication
Description
Score on stress communication (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in satisfaction with dyadic coping
Description
Score on satisfaction with dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in joint dyadic coping
Description
Score on joint dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in perceived stress
Description
Score on perceived stress (min 0, max 16), as measured by the Perceived Stress Scale. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in anxiety
Description
Score on anxiety symptoms (min 0, max 21), as measured by the Generalized anxiety scale-7. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in depression
Description
Score on depression symptoms (min 0, max 27), as measured by the Patient Health Questionnaire-9. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in protective buffering
Description
Score on protective buffering (min 8, max 40), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in active engagement
Description
Score on active engagement (min 5, max 25), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate better outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in overprotection
Description
Score on overprotection (min 6, max 30), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in psychological quality of life
Description
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.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in physical quality of life
Description
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.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in social quality of life
Description
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.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
Title
Change from baseline to post-intervention in children's quality of life
Description
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.
Time Frame
Baseline, after intervention completion (average 8 months after diagnosis)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of breast surgery, Gentofte Hospital
City
Gentofte
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Stick Together - Pilot Intervention Study
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