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Breast NeoplasmsresilienceNCT06875414

Breast Cancer and Resilience in Couple

An observational study of Breast Neoplasms and Quality of Life, run by Regina Elena Cancer Institute at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasms, Quality of Life
What is being tested?
Nursing care model
How many people
40 participants
Where
1 siteItaly
Study dates
14 Nov 2022to 14 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ilaria Farina, MSN contact

0652666804

ilaria.farina@ifo.it

Silvia Takanen, Dr contact

silvia.takanen@ifo.it

Italy1 site, 1 recruiting

  • IRCCS Regina Elena National Cancer Institute

    Roma, Rome, 00144

    Ilaria Farina, Dr, 0652666804, ilaria.farina@ifo.it

    Silvia Takanen, Dr, silvia.takanen@ifo.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Nursing care model
Keywords
breast cancer, quality of life, resilience, depression
Medical subject headings
Breast Neoplasms, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing care modelBehavioural

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

Study groups in NCT06875414
Study groupRoleWhat they receive
CoupleThe adaptation strategies that the couple uses
Receives: Behavioral: Nursing care model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (3)

  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

    Measured: 24 months

  2. 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

    Measured: 24 months

  3. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study start14 Nov 2022
  3. Primary completion15 Mar 2024
  4. Study completion14 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875414
Sponsor's protocol ID
RS1718/22(2657)
Acronym
resilience
Status last verified
Mar 2025
First submitted
15 Mar 2023
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Badger TA, Segrin C, Hepworth JT, Pasvogel A, Weihs K, Lopez AM. Telephone-delivered health education and interpersonal counseling improve quality of life for Latinas with breast cancer and their supportive partners. Psychooncology. 2013 May;22(5):1035-42. doi: 10.1002/pon.3101. Epub 2012 May 10.

    PubMed 22573418

  • Badr H, Krebs P. A systematic review and meta-analysis of psychosocial interventions for couples coping with cancer. Psychooncology. 2013 Aug;22(8):1688-704. doi: 10.1002/pon.3200. Epub 2012 Oct 9.

    PubMed 23045191

  • Belcher AJ, Laurenceau JP, Graber EC, Cohen LH, Dasch KB, Siegel SD. Daily support in couples coping with early stage breast cancer: maintaining intimacy during adversity. Health Psychol. 2011 Nov;30(6):665-73. doi: 10.1037/a0024705. Epub 2011 Aug 8.

    PubMed 21823795

  • Bigatti SM, Steiner JL, Makinabakan N, Hernandez AM, Johnston E, Storniolo AM. Matched and mismatched cognitive appraisals in patients with breast cancer and their partners: implications for psychological distress. Psychooncology. 2012 Nov;21(11):1229-36. doi: 10.1002/pon.2028. Epub 2011 Sep 1.

    PubMed 21882286

  • Brandao T, Schulz MS, Matos PM. Psychological intervention with couples coping with breast cancer: a systematic review. Psychol Health. 2014;29(5):491-516. doi: 10.1080/08870446.2013.859257. Epub 2013 Nov 27.

    PubMed 24279379

  • Christie KM, Meyerowitz BE, Stanton AL, Rowland JH, Ganz PA. Characteristics of breast cancer survivors that predict partners' participation in research. Ann Behav Med. 2013 Aug;46(1):107-13. doi: 10.1007/s12160-013-9477-7.

    PubMed 23456213

  • Dalton WT 3rd, Nelson DV, Brobst JB, Lindsay JE, Friedman LC. Psychosocial variables associated with husbands' adjustment three months following wives' diagnosis of breast cancer. J Cancer Educ. 2007 Winter;22(4):245-9. doi: 10.1007/BF03174124.

    PubMed 18067437

  • Duggleby W, Doell H, Cooper D, Thomas R, Ghosh S. The quality of life of male spouses of women with breast cancer: hope, self-efficacy, and perceptions of guilt. Cancer Nurs. 2014 Jan-Feb;37(1):E28-35. doi: 10.1097/NCC.0b013e31827ca807.

    PubMed 23348665

  • Fergus KD, Gray RE. Relationship vulnerabilities during breast cancer: patient and partner perspectives. Psychooncology. 2009 Dec;18(12):1311-22. doi: 10.1002/pon.1555.

    PubMed 19353517

  • Hoga LA, Mello DS, Dias AF. Psychosocial perspectives of the partners of breast cancer patients treated with a mastectomy: an analysis of personal narratives. Cancer Nurs. 2008 Jul-Aug;31(4):318-25. doi: 10.1097/01.NCC.0000305748.43367.1b.

    PubMed 18600120

  • Hubbard G, Menzies S, Flynn P, Adams S, Haseen F, Thomas I, Scanlon K, Reed L, Forbat L. Relational mechanisms and psychological outcomes in couples affected by breast cancer: a systematic narrative analysis of the literature. BMJ Support Palliat Care. 2013 Sep;3(3):309-17. doi: 10.1136/bmjspcare-2012-000274. Epub 2012 Oct 25.

    PubMed 24644749

  • Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.

    PubMed 20885305

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms and Quality of Life, run by Regina Elena Cancer Institute at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ilaria Farina, MSN (0652666804, ilaria.farina@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EORTC-QLQ C30 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06875414, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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