Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners (HIH)
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Purpose
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Psychological intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial. |
- Change in Impact of Event Scale (IES) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
- Change in The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
- Change in The Profile of Mood States - Short Form (POMS-SF) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]Assesses mood changes. Assessed by both patients and partners
- Change in Dyadic Adjustment Scale - Revised (DAS-R) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners
- Change in Relationship Questionnaire (RQ) [ Time Frame: Baseline, 2 weeks post-intervention, 10 months follow-up ] [ Designated as safety issue: No ]RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners
- Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
- Change in Functional Assessment of Cancer Therapy - general population (FACT-GP) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]Assesses health-related quality of life. Assessed by partners
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]Assesses individual fellings of fatigue. Assessed by the patients
- Change in Post Traumatic Growth Inventory [ Time Frame: 2-weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners
- Change in EuroQol-5 Dimensions (EQ-5D) [ Time Frame: Baseline, 2 weeks post-intervention and 10 months follow-up ] [ Designated as safety issue: No ]Assesses health-related quality of life. Assessed by both patients and partners
| Estimated Enrollment: | 220 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Psychological Intervention |
Behavioral: Psychological intervention
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
|
| No Intervention: 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Denmark | |
| Herlev University Hospital | |
| Herlev, Denmark, 2730 | |
| Odense University Hospital | |
| Odense, Denmark, 5000 | |
| Ringsted Hospital | |
| Ringsted, Denmark, 4100 | |
| Principal Investigator: | Dorte Gilså Hansen, PhD | University of Southern Denmark |
| Study Chair: | Mariët Hagedoorn, Professor | University of Groningen |
| Study Chair: | Christoffer Johansen, Professor | Danish Cancer Society |
More Information
No publications provided
| Responsible Party: | Anne Nicolaisen, MPH, Ph.D. student, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01368380 History of Changes |
| Other Study ID Numbers: | NFK-SDU-2011-5 |
| Study First Received: | May 23, 2011 |
| Last Updated: | February 24, 2013 |
| Health Authority: | Denmark: The Ministry of the Interiour and Health |
Keywords provided by University of Southern Denmark:
|
Breast cancer Partners Couples Attachment Intervention |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013