Breast CancerHIHNCT01368380
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners
A study testing Psychological intervention in people with Breast Cancer, run by University of Southern Denmark at 3 sites in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients having a previous cancer diagnosis
- Neoadjuvant therapy for breast cancer
- Previous hospital admission with diagnosed psychotic episodes
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Herlev University Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
Ringsted Hospital
Ringsted, 4100
About this study
Official title: Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Psychological intervention
- Keywords
- Breast cancer, Partners, Couples, Attachment, Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionBehavioural
Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Not described Receives: Behavioral: Psychological intervention |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Impact of Event Scale (IES)
IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
Measured: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in The Hospital Anxiety and Depression Scale (HADS)
Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
Measured: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in The Profile of Mood States - Short Form (POMS-SF)
Assesses mood changes. Assessed by both patients and partners
Measured: Baseline, 2 weeks post-intervention, 10 months follow-up
Secondary outcomes (7)
Change in Dyadic Adjustment Scale - Revised (DAS-R)
Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners
Measured: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Relationship Questionnaire (RQ)
RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners
Measured: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Assesses health-related quality of life with additional questions for women dignosed with breast cancer.
Measured: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Assesses health-related quality of life. Assessed by partners
Measured: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
Assesses individual fellings of fatigue. Assessed by the patients
Measured: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Post Traumatic Growth Inventory
Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners
Measured: 2-weeks post-intervention and 10 months follow-up
Change in EuroQol-5 Dimensions (EQ-5D)
Assesses health-related quality of life. Assessed by both patients and partners
Measured: Baseline, 2 weeks post-intervention and 10 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Ringsted Hospital, University of Copenhagen, Region of Southern Denmark, Danish Cancer Society
- Responsible party
- Principal investigator, Anne Nicolaisen, University of Southern Denmark
- Investigators
- Dorte G Hansen, PhD, Principal investigator, University of Southern DenmarkMariët Hagedoorn, Professor, Study chair, University of GroningenChristoffer Johansen, Professor, Study chair, Danish Cancer SocietyHenrik Flyger, MD, Ph. D, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368380
- Sponsor's protocol ID
- NFK-SDU-2011-5
- Acronym
- HIH
- Status last verified
- Feb 2015
- First submitted
- 23 May 2011
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25815190
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01368380
- Acronym / sponsor ID
- HIH / NFK-SDU-2011-5
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Partners, Couples, Attachment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Ringsted Hospital, University of Copenhagen, Region of Southern Denmark, Danish Cancer Society
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Psychological intervention |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients having a previous cancer diagnosis
- Neoadjuvant therapy for breast cancer
- Previous hospital admission with diagnosed psychotic episodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological interventionCouples in the intervention group attends six to eight couple-sessions performed by a psychologist. | Behavioural | Psychological Intervention |
Primary outcome
Change in Impact of Event Scale (IES)
Time frame: Baseline, 2 weeks post-intervention, 10 months follow-up
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
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
Assesses mood changes. Assessed by both patients and partners
7 secondary outcomes
Change in Dyadic Adjustment Scale - Revised (DAS-R)
Time frame: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Relationship Questionnaire (RQ)
Time frame: Baseline, 2 weeks post-intervention, 10 months follow-up
Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)
Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up
Change in Post Traumatic Growth Inventory
Time frame: 2-weeks post-intervention and 10 months follow-up
Change in EuroQol-5 Dimensions (EQ-5D)
Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Derived from this study: PubMed 25815190Nicolaisen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorte G Hansen, PhD principal investigator
University of Southern Denmark
Mariët Hagedoorn, Professor study chair
University of Groningen
Christoffer Johansen, Professor study chair
Danish Cancer Society
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention in people with Breast Cancer, run by University of Southern Denmark at 3 sites in Denmark.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Impact of Event Scale (IES) (time frame: Baseline, 2 weeks post-intervention, 10 months follow-up). The study lists 3 primary outcomes in all. 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 NCT01368380, which also lists 1 linked publication.
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 26 Feb 2015.