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NCT Number: NCT06875414

Breast Cancer and Resilience in Couple

This is a prospective pilot study examining the couple's dyadic attitudes from diagnosis to 24 months later when one member is affected by illness and the adaptive strategies the couple employs when stressful events occur.

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Key information

Conditions

Breast Neoplasms Behavior Behavioral Symptoms Breast Diseases Depression Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The patients taking part in the study and their partners are examined from the time of the woman's breast cancer diagnosis up to 24 months later with the help of questionnaires and a focus group in order to understand the couple's coping strategies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Woman diagnosed with stage 1, 2 or 3 breast cancer
  • age> 18 years (patient and partner)
  • The partner must have lived with the woman for at least 6 months at diagnosis and treatment
  • Patients under treatment at the radiotherapy clinic
  • Subjects available and able to answer questionnaires, interviews, and / or participate in focus groups
  • Informed consent

Exclusion criteria

Cognitive deficits and / or inability to comply with the provisions of the study

Treatment and study plan

Nursing care model

Behavioral

Describe relation between resilience, quality of life and depression and marital adaptation in the population considered from diagnosis to 24 months later.

Primary outcomes

  1. EORTC-QLQ C30

    Time frame: 24 months

    The questionnaire EORTC-QLQ C30 (Kaasa, S., Bjordal, K., Aaronson, N.,1995) will evaluate the quality of life and will be administered to patients and their partners during a scheduled check-up visit at the Institute

Secondary outcomes

  1. Marital Adjustment Test

    Time frame: 24 months

    Marital Adjustment Test (Locke and Wallace, 1959), this test validated in Italian, to investigate marital satisfaction, and will be administered to patients and their partners during a scheduled check-up visit at the Institute

  2. PHQ-9 Scale

    Time frame: 24 months

    PHQ-9 Scale (Spitzer, Kroenke, Williams, 1999) validated in Italian, this questionnaire will be administered to patients and their partners during a scheduled check-up visit at the Institute to investigate psychological adjustment, in particular the presence of depression

  3. Resilience Scale

    Time frame: 24 months

    Resilience Scale (Wagnild, G. M., & Young, H. M., 1993) validated in Italian, administered to patients and their partners during a scheduled check-up visit at the Institute to investigate resilience in adults.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilaria Farina, MSN

CONTACT

[email protected]

0652666804

Silvia Takanen, Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

Breast Cancer, Resilience, Quality of Life and Depression in Couples From Diagnosis to 24 Months Later: Prospective Pilot Study

Acronym: resilience

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

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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