Clinical trial NCT05760755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Committee for Health Education
name: TrygFonden, Denmark
name: Sygekassernes Helsefond
name: Danish Cancer Society
name: University Hospital, Gentofte, Copenhagen
First posted: 2023-03-08
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Participation (Acceptability 1)
timeFrame: baseline
measure: Participants satisfaction (Acceptability 2)
timeFrame: Post-intervention follow-up (7-9 months post diagnosis)
measure: Completion (Feasibility)
timeFrame: Post-intervention (7-9 months post diagnosis)
Secondary outcomes:
measure: Change from baseline to post-intervention in supportive dyadic coping
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in delegated dyadic coping
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in negative dyadic coping
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in stress communication
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in satisfaction with dyadic coping
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in joint dyadic coping
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in perceived stress
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in anxiety
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in depression
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in protective buffering
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in active engagement
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in overprotection
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in psychological quality of life
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in physical quality of life
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in social quality of life
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
measure: Change from baseline to post-intervention in children's quality of life
timeFrame: Baseline, after intervention completion (average 8 months after diagnosis)
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Department of breast surgery, Gentofte Hospital
Study officials:
References: