Group-based or Individual Information About Disease and Treatment Plan
Primary Purpose
Prostate Cancer, Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Group information
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Patient education, information, communication
Eligibility 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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group and Individual information
Individual information
Arm Description
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
Outcomes
Primary Outcome Measures
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Knowledge
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
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Anxiety
STAI-State and Trait Anxiety Inventory
Anxiety
STAI-State and Trait Anxiety Inventory
Anxiety
STAI-State and Trait Anxiety Inventory
Adverse events
CTCEA, Common Terminology Criteria for Adverse Events
Adverse events
CTCEA, Common Terminology Criteria for Adverse Events
Full Information
NCT ID
NCT01699672
First Posted
September 21, 2012
Last Updated
January 25, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01699672
Brief Title
Group-based or Individual Information About Disease and Treatment Plan
Official Title
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Problems recruiting patients (not willing, travel time, no respons)
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Breast Cancer
Keywords
Patient education, information, communication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group and Individual information
Arm Type
Experimental
Arm Description
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Arm Title
Individual information
Arm Type
No Intervention
Arm Description
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
Intervention Type
Other
Intervention Name(s)
Group information
Intervention Description
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Primary Outcome Measure Information:
Title
Knowledge
Description
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Time Frame
1 week
Title
Knowledge
Description
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Time Frame
2 weeks
Title
Knowledge
Description
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
Time Frame
9 weeks
Title
Patients Subjective state of information
Description
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Time Frame
1 week
Title
Patients Subjective state of information
Description
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Time Frame
2 weeks
Title
Patients Subjective state of information
Description
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Time Frame
9 weeks
Title
Anxiety
Description
STAI-State and Trait Anxiety Inventory
Time Frame
1 week
Title
Anxiety
Description
STAI-State and Trait Anxiety Inventory
Time Frame
2 weeks
Title
Anxiety
Description
STAI-State and Trait Anxiety Inventory
Time Frame
9 weeks
Title
Adverse events
Description
CTCEA, Common Terminology Criteria for Adverse Events
Time Frame
2 weeks
Title
Adverse events
Description
CTCEA, Common Terminology Criteria for Adverse Events
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Kaasa, MD, Prof.
Organizational Affiliation
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ola Berger, MD
Organizational Affiliation
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bjørn H Gønberg, MD, PhD
Organizational Affiliation
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kari Sand, Cand Philol
Organizational Affiliation
PRC, European Palliative Care Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jo Å Lund, MD, PhD
Organizational Affiliation
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jon H Loge, MD, Prof.
Organizational Affiliation
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
Official's Role
Study Chair
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29614997
Citation
Berger O, Gronberg BH, Loge JH, Kaasa S, Sand K. Cancer patients' knowledge about their disease and treatment before, during and after treatment: a prospective, longitudinal study. BMC Cancer. 2018 Apr 3;18(1):381. doi: 10.1186/s12885-018-4164-5.
Results Reference
derived
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Group-based or Individual Information About Disease and Treatment Plan
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