Stick Together - Pilot Intervention Study

Breast Cancer Female Clinical Trial

Official title:

Stick Together - A Dyadic Web-intervention for Younger Patients With Breast Cancer and Their Partners

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05760755
• Other study ID #: P-2020-246
• Secondary ID: H-22032044
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Denmark	Department of breast surgery, Gentofte Hospital	Gentofte

Sponsors (6)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society, Danish Committee for Health Education, Sygekassernes Helsefond, TrygFonden, Denmark, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation (Acceptability 1)	Percentage of eligible participants consenting to participate	baseline
Primary	Participants satisfaction (Acceptability 2)	Percentage of participants satisfied with the intervention	Post-intervention follow-up (7-9 months post diagnosis)
Primary	Completion (Feasibility)	Percentage of participants completing the intervention (65% completion)	Post-intervention (7-9 months post diagnosis)
Secondary	Change from baseline to post-intervention in supportive dyadic coping	Score on supportive dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in delegated dyadic coping	Score on delegated dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in negative dyadic coping	Score on negative dyadic coping (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in stress communication	Score on stress communication (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in satisfaction with dyadic coping	Score on satisfaction with dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in joint dyadic coping	Score on joint dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in perceived stress	Score on perceived stress (min 0, max 16), as measured by the Perceived Stress Scale. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in anxiety	Score on anxiety symptoms (min 0, max 21), as measured by the Generalized anxiety scale-7. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in depression	Score on depression symptoms (min 0, max 27), as measured by the Patient Health Questionnaire-9. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in protective buffering	Score on protective buffering (min 8, max 40), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in active engagement	Score on active engagement (min 5, max 25), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate better outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in overprotection	Score on overprotection (min 6, max 30), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in psychological quality of life	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.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in physical quality of life	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.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in social quality of life	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.	Baseline, after intervention completion (average 8 months after diagnosis)
Secondary	Change from baseline to post-intervention in children's quality of life	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.	Baseline, after intervention completion (average 8 months after diagnosis)