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Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.


The intervention intends to improving the patient and partners well-being, quality of life
and their relationship adjustment.

The couples in the intervention group participates i six to eight couple sessions. The
sessions is conducted by an experienced psychologist and takes place one to five months
after the patients cancer diagnosis. The control group receives usual care.

The framework of the intervention is attachment theory and the psychologists support and
advise the couples in talking candidly about their feelings regarding their new life
situation with cancer. The psychologist focus on the couples ability to feel comfortable and
safe in each others presence.


Inclusion Criteria:



- Women newly diagnosed with a primary breast cancer (in the last 4 weeks)

- Women cohabiting with a male partner in a romantic relationship

- Patient and partner speaks and reads danish

Exclusion Criteria:

- Patients having a previous cancer diagnosis

- Neoadjuvant therapy for breast cancer

- Previous hospital admission with diagnosed psychotic episodes

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Impact of Event Scale (IES)

Outcome Description:

IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners

Outcome Time Frame:

Baseline, 2 weeks post-intervention, 10 months follow-up

Safety Issue:

No

Principal Investigator

Dorte Gilså Hansen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern Denmark

Authority:

Denmark: The Ministry of the Interiour and Health

Study ID:

NFK-SDU-2011-5

NCT ID:

NCT01368380

Start Date:

October 2011

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Partners
  • Couples
  • Attachment
  • Intervention
  • Breast Neoplasms

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