Stick Together - Pilot Intervention Study

NCT ID: NCT05760755

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-08-06

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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group (Stick Together)

Intervention group (all participants)

Group Type EXPERIMENTAL

Stick Together

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* women newly diagnosed with first primary breast cancer, treated with curative intent at Department of breast surgery, Gentofte Hospital
* living with a romantic partner


* living in romantic partnership with a patient eligible for the intervention

Exclusion Criteria

* 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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Committee for Health Education

OTHER

Sponsor Role collaborator

TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Annika von Heymann

Post.doc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of breast surgery, Gentofte Hospital

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-22032044

Identifier Type: OTHER

Identifier Source: secondary_id

P-2020-246

Identifier Type: -

Identifier Source: org_study_id

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