Breast Cancer and Resilience in Couple (resilience)

March 12, 2025 updated by: Silvia Takanen, Regina Elena Cancer Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Rome
      • Roma, Rome, Italy, 00144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Couple
The adaptation strategies that the couple uses
Behavioral: Nursing care model
Describe relation between resilience, quality of life and depression and marital adaptation in the population considered from diagnosis to 24 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Actual)

March 15, 2024

Study Completion (Estimated)

November 14, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1718/22(2657)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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