Stick Together - Pilot Intervention Study

NCT05760755 | Completed

• 2 other identifiers: P-2020-246H-22032044
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Change from baseline to post-intervention in supportive dyadic coping

  Baseline, after intervention completion (average 8 months after diagnosis)

• Change from baseline to post-intervention in delegated dyadic coping

  Baseline, after intervention completion (average 8 months after diagnosis)

• Change from baseline to post-intervention in negative dyadic coping

  Baseline, after intervention completion (average 8 months after diagnosis)

• Change from baseline to post-intervention in stress communication

  Baseline, after intervention completion (average 8 months after diagnosis)

• Change from baseline to post-intervention in satisfaction with dyadic coping

  Baseline, after intervention completion (average 8 months after diagnosis)

Study Arms (1)

Intervention group (Stick Together)

EXPERIMENTAL

Intervention group (all participants)

Behavioral: Stick Together

Interventions

Stick Together 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.

Intervention group (Stick Together)

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Committee for Health Education: collaborator
• TrygFonden, Denmark: collaborator
• Sygekassernes Helsefond: collaborator
• Danish Cancer Society: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Department of breast surgery, Gentofte Hospital

Gentofte Municipality, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post.doc.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 8, 2023
• Study Start: February 1, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon completion of study and publication of results.

Locations

DK (1)