Group-based or Individual Information About Disease and Treatment Plan

Not Applicable

Terminated

• Conditions: Breast Cancer; Prostate Cancer
• Interventions: Other: Group information

• Registration Number: NCT01699672
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2012-09-21
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

-Patients not fulfilling inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group and Individual information	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.

Primary Outcome Measures

Name	Time	Method
Knowledge	9 weeks	Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.

Secondary Outcome Measures

Name	Time	Method
Anxiety	9 weeks	STAI-State and Trait Anxiety Inventory
Adverse events	9 weeks	CTCEA, Common Terminology Criteria for Adverse Events
Quality of Life	9 weeks	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
Patients Subjective state of information	9 weeks	European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway