Stick Together - Pilot Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stick Together - A Dyadic Web-intervention for Younger Patients With Breast Cancer and Their Partners

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Behavioral: Stick Together


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (Stick Together)<br>Intervention group (all participants) | Behavioral: Stick Together<br>* 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.<br>|

What is the study measuring?
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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) |