Breast Cancer and Resilience in Couple

Recruiting

• Conditions: Breast Neoplasms; Quality of Life

• Registration Number: NCT06875414
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-11-14
• Study First Submitted: 2023-03-15
• Primary Completion: 2024-03-15
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Completion: 2025-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EORTC-QLQ C30	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 Outcome Measures

Name	Time	Method
Marital Adjustment Test	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
PHQ-9 Scale	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
Resilience Scale	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.

Trial Locations

Locations (1)

IRCCS Regina Elena National Cancer Institute; 🇮🇹 Roma, Rome, Italy