Clinical trial NCT06875414: Breast Cancer and Resilience in Couple
Official title: Breast Cancer, Resilience, Quality of Life and Depression in Couples From Diagnosis to 24 Months Later: Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Quality of Life
Keywords: breast cancer
quality of life
resilience
depression
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 40 couples with women affected by breast cancer who had lived together for at least six months before the diagnosis of breast cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: EORTC-QLQ C30
timeFrame: 24 months
Secondary outcomes:
measure: Marital Adjustment Test
timeFrame: 24 months
measure: PHQ-9 Scale
timeFrame: 24 months
measure: Resilience Scale
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS Regina Elena National Cancer Institute
state: Rome
Study officials:
References:
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