Short summary

Integrating open dialogue about complementary alternative medicine (ODC-COC) involves two intertwined elements; a person-centered approach and counseling on complementary alternative medicine using evidence-based information. In this, project we hypothize that ODC-COC will improve patients quality of life and well-being compared to standard care. Also, we anticipate that ODC-COC has potentials in reducing patients concerns and decisional regret regarding the conventional oncology treatment. 

Rationale

Although sophisticated conventional medicine has led to significant advances in cancer treatment, increasing rates of patients with cancer use complementary and alternative medicine (CAM) such as diet supplements, massage, acupuncture, etc. as an adjunct to conventional oncology care. Given the potentially harmful interactions between certain types of CAM and conventional medicine, it is crucial that open dialogue about CAM between patients and professionals is integrated in conventional oncology care. Studies show that CAM as an adjunct to conventional oncology care improves patients' quality of life and well-being, e.g. by reducing side-effects such as nausea and vomiting fear, fatigue, depression and pain, and CAM has been shown to enhance hope, self-care, self-control, and empowerment. Hence, open dialogue about CAM with valid information about the benefits and risks of CAM may ultimately improve safety, health, quality of life and well-being of the patients. Furthermore, studies suggest that dialogue about CAM during oncology consultations lead to greater patient engagement in the dialogue, more patient-centered communication, and higher patient and clinician satisfaction. It also addresses patient stress and uncertainty, reduces exposure to misleading information, and enhances the patient-physician relationship, which is paramount in delivering high-quality care. 

Open dialogue about CAM is, however, not systematically integrated in conventional oncology care. This is problematic since studies show that lack of open discussion about CAM in the conventional oncology setting 1) restricts patients' ability to seek advice about CAM from conventional health professionals about the safety of combining different treatments (conventional and CAM), 2) makes patients more anxious and 3) (although rarely) triggers patients to reluctantly abandon conventional medicine. Also, studies exploring changes in patient-reported symptoms, quality of life and well-being claim to have found measurable, clinically significant improvements on patients' main concerns and well-being after participating in a consultation about CAM integrated in the oncology care. Likewise, significant improvement of depression, anxiety, well-being, psychological distress and global distress (sum of pain, fatigue, nausea, depression) has been observed. These studies are, however, limited by the fact that there was no control group and changes in patients' symptoms, quality of life and well-being cannot solely rely on the consultation about CAM. 

In a previous study we conducted a phase two, parallel-group, randomized controlled trial assessing the effect of open dialogue about CAM integrated in conventional oncology care (ODC-COC) on the frequency and degree of adverse events (ClinicalTrials.gov identifier NCT03857776). The quality of life and well-being of the patients was also evaluated. Data are currently being collected, but preliminary findings show improved quality of life and well-being after participating in ODC-COC. However, in order to assess significant effects of ODC-COC on patients' quality of life a study with greater statistical power is warranted. The preliminary findings suggest that the improved well-being of patients participating in ODC-COC include individual counselling on what matters the most to the patient, and feeling comfortable and less concerned with the decision about receiving conventional oncology medicine. This indicates that ODC-COC ultimately reduces patients' concerns as well as it potentially reduces uncertainty and decisional regret regarding decisions about conventional oncology treatment. According to our knowledge, it has not yet been explored systematically whether ODC-COC reduces patients' concerns and decisional regret.

Study objectives 

We hypothize that ODC-COC based on a person-centered, empowering approach and reliable advice about CAM will improve patients' quality of life and well-being compared to standard care including referral to www.kabcancer.dk.

Further, we anticipate that ODC-COC will reduce patient reported concerns and decisional regret.

Description of the cohort

Adult patients (age 18 or more):

-who are diagnosed with a new primary cancer or a relapse of cancer within the last 3 months

-who have planned or initiated oncologic medical treatment at the Department of Oncology, Vejle Hospital

- where at least two months of oncologic treatment is realistic 

- where at least six months of life expectancy is realistic

Data and biological material

Questionnaires:

Quality of life (EORTC QLQ C30)

Depression and anxiety (Hospital Anxiety and Depression Scale - HADS)

Top concerns and well-being (MYCaW)

Decision regret (Decision Regret Scale -DRS)

Collaborating researchers and departments

Department of Oncology, University of Lillebaelt Hospital

• Consultant Oncologist, Clinical Associate Professor, PhD, Lars Henrik Jensen

Department of Nursing Science, Public Health, Aarhus.

• Professor in Nursing Science, MSc in Nursing, PhD, Charlotte Delmar

University of Southern Denmark.

• Associate Professor, MScN, PhD, Birgitte Nørgaard