Clinical trial NCT01368380: Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
Official title: Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Partners
Couples
Attachment
Intervention
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Ringsted Hospital
name: University of Copenhagen
name: Region of Southern Denmark
name: Danish Cancer Society
First posted: 2011-06-07
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Impact of Event Scale (IES)
timeFrame: Baseline, 2 weeks post-intervention, 10 months follow-up
measure: Change in The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 2 weeks post-intervention, 10 months follow-up
measure: Change in The Profile of Mood States - Short Form (POMS-SF)
timeFrame: Baseline, 2 weeks post-intervention, 10 months follow-up
Secondary outcomes:
measure: Change in Dyadic Adjustment Scale - Revised (DAS-R)
timeFrame: Baseline, 2 weeks post-intervention, 10 months follow-up
measure: Change in Relationship Questionnaire (RQ)
timeFrame: Baseline, 2 weeks post-intervention, 10 months follow-up
measure: Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: Baseline, 2 weeks post-intervention and 10 months follow-up
measure: Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
timeFrame: Baseline, 2 weeks post-intervention and 10 months follow-up
measure: Change in Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Baseline, 2 weeks post-intervention and 10 months follow-up
measure: Change in Post Traumatic Growth Inventory
timeFrame: 2-weeks post-intervention and 10 months follow-up
measure: Change in EuroQol-5 Dimensions (EQ-5D)
timeFrame: Baseline, 2 weeks post-intervention and 10 months follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Ringsted
country: Denmark
facility: Ringsted Hospital
Study officials:
affiliation: University of Southern Denmark
name: Dorte G Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Groningen
name: Mariët Hagedoorn, Professor
role: STUDY_CHAIR
affiliation: Danish Cancer Society
name: Christoffer Johansen, Professor
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Henrik Flyger, MD, Ph. D
role: STUDY_CHAIR
References:
citation: Nicolaisen A, Hansen DG, Hagedoorn M, Flyger HE, Rottmann N, Nielsen P, Soe K, Pedersen AE, Johansen C. Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial. BMC Psychol. 2014 Jul 14;2(1):19. doi: 10.1186/2050-7283-2-19. eCollection 2014.