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Trial Title:
Stick Together - Pilot Intervention Study
NCT ID:
NCT05760755
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Stick Together
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.
Arm group label:
Intervention group (Stick Together)
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.
Criteria for 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)
Gender:
Female
Minimum age:
25 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of breast surgery, Gentofte Hospital
Address:
City:
Gentofte
Country:
Denmark
Start date:
February 1, 2023
Completion date:
May 31, 2024
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Danish Committee for Health Education
Agency class:
Other
Collaborator:
Agency:
TrygFonden, Denmark
Agency class:
Industry
Collaborator:
Agency:
Sygekassernes Helsefond
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Collaborator:
Agency:
University Hospital, Gentofte, Copenhagen
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05760755
