Group-based or Individual Information About Disease and Treatment Plan

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01699672
First received: September 21, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.

Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.


Condition Intervention
Prostate Cancer
Breast Cancer
Other: Group information

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Knowledge [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.

  • Knowledge [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.

  • Knowledge [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30

  • Patients Subjective state of information [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25

  • Patients Subjective state of information [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25

  • Patients Subjective state of information [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25

  • Anxiety [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    STAI-State and Trait Anxiety Inventory

  • Anxiety [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    STAI-State and Trait Anxiety Inventory

  • Anxiety [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    STAI-State and Trait Anxiety Inventory

  • Adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    CTCEA, Common Terminology Criteria for Adverse Events

  • Adverse events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    CTCEA, Common Terminology Criteria for Adverse Events


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Other: Group information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
No Intervention: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.

Detailed Description:

There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.

The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.

Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
  • Prostate cancer patients that are candidates for curative radiotherapy
  • Signed informed consent
  • Patient expected to be able to complete the planned treatment and the study procedures
  • 18years or older

Exclusion Criteria:

-Patients not fulfilling inclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699672

Contacts
Contact: Ola Berger, MD 004797519419 ola.berger@ntnu.no
Contact: Bjørn H Grønberg, MD, PhD 0047297878 bjorn.h.gronberg@gmail.com

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Ola Berger, MD    0047 97519419    ola.berger@ntnu.no   
Sub-Investigator: Bjørn H Grønberg, MD, PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Stein Kaasa, MD, Prof. St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Study Director: Ola Berger, MD St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Study Chair: Bjørn H Gønberg, MD, PhD St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Study Chair: Kari Sand, Cand Philol PRC, European Palliative Care Research Center
Study Chair: Jo Å Lund, MD, PhD St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Study Chair: Jon H Loge, MD, Prof. National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01699672     History of Changes
Other Study ID Numbers: REK2012/1238
Study First Received: September 21, 2012
Last Updated: January 22, 2014
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Patient education
information
communication

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014