Breast Cancer and Resilience in Couple
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRegina Elena Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Nursing care model
BehavioralDescribe relation between resilience, quality of life and depression and marital adaptation in the population considered from diagnosis to 24 months later.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Couple1 intervention
Trial outcomes
Primary outcomes
1
EORTC-QLQ C30
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
Time frame
24 monthsSecondary outcomes
1
Marital Adjustment Test
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
Time frame
24 months2
PHQ-9 Scale
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
Time frame
24 months3
Resilience Scale
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.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov