Group-based or Individual Information About Disease and Treatment Plan

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01699672
• Other study ID #: REK2012/1238
• Status: Terminated
• Phase: N/A
• First received: September 21, 2012
• Last updated: January 25, 2017
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.	1 week
Primary	Knowledge	Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.	2 weeks
Primary	Knowledge	Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.	9 weeks
Secondary	Quality of Life	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30	9 weeks
Secondary	Patients Subjective state of information	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25	1 week
Secondary	Patients Subjective state of information	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25	2 weeks
Secondary	Patients Subjective state of information	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25	9 weeks
Secondary	Anxiety	STAI-State and Trait Anxiety Inventory	1 week
Secondary	Anxiety	STAI-State and Trait Anxiety Inventory	2 weeks
Secondary	Anxiety	STAI-State and Trait Anxiety Inventory	9 weeks
Secondary	Adverse events	CTCEA, Common Terminology Criteria for Adverse Events	2 weeks
Secondary	Adverse events	CTCEA, Common Terminology Criteria for Adverse Events	9 weeks