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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01699672
Enrollment
98
Registered
2012-10-04
Start date
2012-10-31
Completion date
2015-07-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Prostate Cancer

Keywords

Patient education, information, communication

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.

Interventions

OTHERGroup 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.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge1 weekKnowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.

Secondary

MeasureTime frameDescription
Quality of Life9 weeksEuropean Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
Patients Subjective state of information1 weekEuropean Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Anxiety1 weekSTAI-State and Trait Anxiety Inventory
Adverse events2 weeksCTCEA, Common Terminology Criteria for Adverse Events

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026