Stick Together - Pilot Intervention Study

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: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: Stick Together

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: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Participation (Acceptability 1)	Percentage of eligible participants consenting to participate	baseline
Participants satisfaction (Acceptability 2)	Percentage of participants satisfied with the intervention	Post-intervention follow-up (7-9 months post diagnosis)
Completion (Feasibility)	Percentage of participants completing the intervention (65% completion)	Post-intervention (7-9 months post diagnosis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, after intervention completion (average 8 months after diagnosis)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society; TrygFonden, Denmark; University Hospital, Gentofte, Copenhagen; Sygekassernes Helsefond; Danish Committee for Health Education

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID 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