Study Stopped
Problems recruiting patients (not willing, travel time, no respons)
Group-based or Individual Information About Disease and Treatment Plan
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 26, 2017
January 1, 2017
2.7 years
September 21, 2012
January 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
1 week
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
2 weeks
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
9 weeks
Secondary Outcomes (9)
Quality of Life
9 weeks
Patients Subjective state of information
1 week
Patients Subjective state of information
2 weeks
Patients Subjective state of information
9 weeks
Anxiety
1 week
- +4 more secondary outcomes
Study Arms (2)
Group and Individual information
EXPERIMENTALThe patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Individual information
NO INTERVENTIONStandard information about disease and treatment from doctor and nurse given at 2 occasions.
Interventions
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
Eligibility Criteria
You may qualify if:
- 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
- years or older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olavs Hospital
Trondheim, Norway
Related Publications (1)
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.
PMID: 29614997DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2012
First Posted
October 4, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
January 26, 2017
Record last verified: 2017-01