Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)

University of Southern Denmark (SDU)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Psychological intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01368380

NFK-SDU-2011-5

Details and patient eligibility

About

This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care

Full description

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.

Enrollment: 198 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Psychological Intervention

Experimental group

Treatment:

Behavioral: Psychological intervention

Usual care

No Intervention group