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Completed

NCT Number: NCT05760755

Stick Together - Pilot Intervention Study

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.

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Key information

Conditions

Breast Cancer Female

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of breast surgery, Gentofte Hospital

Gentofte Municipality, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Participation (Acceptability 1)

    Time frame: baseline

    Percentage of eligible participants consenting to participate

  2. Participants satisfaction (Acceptability 2)

    Time frame: Post-intervention follow-up (7-9 months post diagnosis)

    Percentage of participants satisfied with the intervention

  3. Completion (Feasibility)

    Time frame: Post-intervention (7-9 months post diagnosis)

    Percentage of participants completing the intervention (65% completion)

Secondary outcomes

  1. Change from baseline to post-intervention in supportive dyadic coping

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on supportive dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.

  2. Change from baseline to post-intervention in delegated dyadic coping

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on delegated dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.

  3. Change from baseline to post-intervention in negative dyadic coping

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on negative dyadic coping (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate worse outcome.

  4. Change from baseline to post-intervention in stress communication

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on stress communication (min 4, max 20), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.

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

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on satisfaction with dyadic coping (min 2, max 10), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.

  6. Change from baseline to post-intervention in joint dyadic coping

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on joint dyadic coping (min 5, max 25), as measured by the Dyadic coping inventory subscale. Higher scores indicate better outcome.

  7. Change from baseline to post-intervention in perceived stress

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on perceived stress (min 0, max 16), as measured by the Perceived Stress Scale. Higher scores indicate worse outcome.

  8. Change from baseline to post-intervention in anxiety

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on anxiety symptoms (min 0, max 21), as measured by the Generalized anxiety scale-7. Higher scores indicate worse outcome.

  9. Change from baseline to post-intervention in depression

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on depression symptoms (min 0, max 27), as measured by the Patient Health Questionnaire-9. Higher scores indicate worse outcome.

  10. Change from baseline to post-intervention in protective buffering

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on protective buffering (min 8, max 40), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.

  11. Change from baseline to post-intervention in active engagement

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on active engagement (min 5, max 25), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate better outcome.

  12. Change from baseline to post-intervention in overprotection

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    Score on overprotection (min 6, max 30), as measured by the Ways of Giving Support-questionnaire subscale. Higher scores indicate worse outcome.

  13. Change from baseline to post-intervention in psychological quality of life

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    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.

  14. Change from baseline to post-intervention in physical quality of life

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    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.

  15. Change from baseline to post-intervention in social quality of life

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    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.

  16. Change from baseline to post-intervention in children's quality of life

    Time frame: Baseline, after intervention completion (average 8 months after diagnosis)

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

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

Registry information

Official study title

Stick Together - a Dyadic Web-intervention for Younger Patients with Breast Cancer and Their Partners

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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