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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Other: Group information

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group and Individual 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.	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.
No Intervention: Individual information; Standard information about disease and treatment from doctor and nurse given at 2 occasions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: communication; Patient education; information
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: REK2012/1238