Clinical trial NCT01699672: Group-based or Individual Information About Disease and Treatment Plan
Official title: Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Breast Cancer
Keywords: Patient education
information
communication
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2012-10-04
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge
timeFrame: 1 week
measure: Knowledge
timeFrame: 2 weeks
measure: Knowledge
timeFrame: 9 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 9 weeks
measure: Patients Subjective state of information
timeFrame: 1 week
measure: Patients Subjective state of information
timeFrame: 2 weeks
measure: Patients Subjective state of information
timeFrame: 9 weeks
measure: Anxiety
timeFrame: 1 week
measure: Anxiety
timeFrame: 2 weeks
measure: Anxiety
timeFrame: 9 weeks
measure: Adverse events
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
name: Stein Kaasa, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
name: Ola Berger, MD
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
name: Bjørn H Gønberg, MD, PhD
role: STUDY_CHAIR
affiliation: PRC, European Palliative Care Research Center
name: Kari Sand, Cand Philol
role: STUDY_CHAIR
affiliation: St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
name: Jo Å Lund, MD, PhD
role: STUDY_CHAIR
affiliation: 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
name: Jon H Loge, MD, Prof.
role: STUDY_CHAIR
References:
citation: 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.