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Completed

NCT Number: NCT01368380

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Herlev University Hospital, Herlev, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological intervention

Behavioral

Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. Change in Dyadic Adjustment Scale - Revised (DAS-R)

    Time frame: Baseline, 2 weeks post-intervention, 10 months follow-up

    Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners

  2. Change in Relationship Questionnaire (RQ)

    Time frame: Baseline, 2 weeks post-intervention, 10 months follow-up

    RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners

  3. Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)

    Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up

    Assesses health-related quality of life with additional questions for women dignosed with breast cancer.

  4. Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)

    Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up

    Assesses health-related quality of life. Assessed by partners

  5. Change in Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up

    Assesses individual fellings of fatigue. Assessed by the patients

  6. Change in Post Traumatic Growth Inventory

    Time frame: 2-weeks post-intervention and 10 months follow-up

    Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners

  7. Change in EuroQol-5 Dimensions (EQ-5D)

    Time frame: Baseline, 2 weeks post-intervention and 10 months follow-up

    Assesses health-related quality of life. Assessed by both patients and partners

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Cancer Society
  • Odense University Hospital
  • Region of Southern Denmark
  • Ringsted Hospital
  • University of Copenhagen

Registry information

Official study title

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

Acronym: HIH

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 7, 2011
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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