Know Cancer

or
forgot password

Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study


N/A
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study


PURPOSE: This randomized study included patients diagnosed with breast cancer who
participated in an intervention including education and group psychotherapy lasting 10 weeks
after surgery. The purpose of the study was to enhance Quality of Life, coping and social
relations and to support the women when going through treatment. PATIENTS AND METHODS: We
randomly assigned 210 patients with primary breast cancer to a control or an intervention
group. Patients in the intervention group were offered 2 weekly 6-hour sessions of
psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and
nonparticipants were followed up for QoL, coping and social relations after one, six and
twelve months post intervention and on vital status 5 years after surgical treatment.


Inclusion Criteria:



- Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

Exclusion Criteria:

- Distant metastasis

- Not speaking or understanding Danish

- Over 71 years

- Other life-threatening diseases

- Brain-damaged

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of life

Outcome Description:

Does Quality of Life enhance among a group of primary breast cancer patients who participate in a psychosocial group intervention compared to a control group of primary breast cancer patients who do not recieve any psychosocial intervention?

Outcome Time Frame:

12 months post intervention

Safety Issue:

No

Principal Investigator

Ellen H Boesen, MSc, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100

Authority:

Denmark: Ethics Committee

Study ID:

Camma 2003

NCT ID:

NCT01108224

Start Date:

January 2004

Completion Date:

December 2006

Related Keywords:

  • Breast Cancer
  • Quality of life
  • Coping
  • Social relations
  • Survival
  • Psychotherapy
  • Breast Neoplasms

Name

Location