Stick Together - Pilot Intervention Study
- Conditions
- Breast Cancer Female
- Interventions
- Behavioral: Stick Together
- Registration Number
- NCT05760755
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group (Stick Together) Stick Together Intervention group (all participants)
- Primary Outcome Measures
Name Time Method Participation (Acceptability 1) baseline Percentage of eligible participants consenting to participate
Completion (Feasibility) Post-intervention (7-9 months post diagnosis) Percentage of participants completing the intervention (65% completion)
Participants satisfaction (Acceptability 2) Post-intervention follow-up (7-9 months post diagnosis) Percentage of participants satisfied with the intervention
- Secondary Outcome Measures
Name Time Method Change from baseline to post-intervention in negative dyadic coping 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.
Change from baseline to post-intervention in satisfaction with dyadic coping 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.
Change from baseline to post-intervention in psychological quality of life 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.
Change from baseline to post-intervention in supportive dyadic coping 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.
Change from baseline to post-intervention in joint dyadic coping 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.
Change from baseline to post-intervention in perceived stress 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.
Change from baseline to post-intervention in active engagement 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.
Change from baseline to post-intervention in overprotection 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.
Change from baseline to post-intervention in physical quality of life 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.
Change from baseline to post-intervention in social quality of life 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.
Change from baseline to post-intervention in children's quality of life 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.
Change from baseline to post-intervention in anxiety 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.
Change from baseline to post-intervention in protective buffering 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.
Change from baseline to post-intervention in delegated dyadic coping 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.
Change from baseline to post-intervention in depression 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.
Change from baseline to post-intervention in stress communication 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.
Trial Locations
- Locations (1)
Department of breast surgery, Gentofte Hospital
🇩🇰Gentofte, Denmark