Group-based or Individual Information About Disease and Treatment Plan

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan

Conditions
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Prostate Cancer, Breast Cancer

Intervention / Treatment
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* Other: Group information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group and Individual information<br>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<br>* The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.<br>|
| No Intervention: Individual information<br>Standard information about disease and treatment from doctor and nurse given at 2 occasions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30 | 9 weeks | 
| Patients Subjective state of information | European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25 | 1 week | 
| Patients Subjective state of information | European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25 | 2 weeks | 
| Patients Subjective state of information | European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25 | 9 weeks | 
| Anxiety | STAI-State and Trait Anxiety Inventory | 1 week | 
| Anxiety | STAI-State and Trait Anxiety Inventory | 2 weeks | 
| Anxiety | STAI-State and Trait Anxiety Inventory | 9 weeks | 
| Adverse events | CTCEA, Common Terminology Criteria for Adverse Events | 2 weeks | 
| Adverse events | CTCEA, Common Terminology Criteria for Adverse Events | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient education, information, communication