Mistletoe treatment in cancer-related fatigue: a case report

Cancer-related fatigue (CRF) is a major and very common disabling condition in cancer patients. Treatment options do exist but have limited therapeutic effects. Mistletoe extracts are widely-used complementary cancer treatments whose possible impact on CRF has not been investigated in detail. A 36-year-old Swedish woman with a 10-year history of recurrent breast cancer, suffering from severe CRF, started complementary cancer treatment with mistletoe extracts. Over two and a half years a correspondence was observed between the intensity of mistletoe therapy and the fatigue. Mistletoe extracts seemed to have a beneficial, dose-dependent effect on CRF. Although such effect has also been noted in clinical studies, it has never been the subject of detailed investigation. More research should clarify these observations

Komplementär och alternativ medicin vid cancer : från användning till en randomiserad kontrollerad studie

Background: Complementary and alternative medicine (CAM) are non-conventional health care approaches used in parallel with or instead of conventional medicine. Little is known about Swedish patients’ patterns of complementary CAM use in the context of cancer. Patient-provider communication concerning CAM is crucial and research about communication in situations when patients decline recommended cancer treatment and consider CAM as an alternative is scarce. One commonly used CAM approach is an herbal medicinal product from mistletoe. An open-label trial on mistletoe extract for patients with advanced pancreatic cancer reported promising results on overall survival and quality of life. Due to limited treatment options for this group of patients, this approach needs to be investigated further.  Aim: The overall aim of this thesis is to explore CAM use from patients’ and physicians’ perspectives and to design a placebo-controlled randomized clinical trial to assess mistletoe extract as a complement to standard treatment in patients with advanced pancreatic cancer.  Methods: A cross-sectional design with quantitative and qualitative mixed methods was used in Study I including 755 patients with solid tumors. In Study II a qualitative design with face-to-face interviews with seven patients with cancer and ten physicians from cancer care was used. In Study III, a study protocol for a multicenter, parallel group, double-blind, randomized, placebo-controlled clinical trial (RCT) was developed. Mixed methods were used by two nested ancillary studies on sub-sets of participants with a translational and a qualitative design respectively. Patients with advanced pancreatic cancer (n=290) were included; mistletoe extract/placebo was added to treatment of choice for the duration of nine months. The trial is currently being conducted.  Results: One of four patients with solid tumors used CAM parallel with conventional treatment. Main reasons motivations were the hope for improvement of physical, general, and emotional wellbeing and the body’s ability to fight cancer. Satisfaction with CAM usage was generally high; reported adverse effects few and mild. One third had discussed their CAM use with cancer care providers. More than half of the patients thought that cancer care providers should be able to discuss and/or consider use of CAM modalities in cancer care.  Patients declining conventional cancer treatment while using CAM had a variety of reasons for their choices: many of them valued CAM for a broader perspective on health and illness in the context of mind, body and spirit. The wish to take an active stance in relation to treatment decisions and previous negative experiences from conventional care were also cited as motives. Some patients felt a lack of respect for their choices and indicated lack of knowledge and interest on their physicians’ part. Some physicians felt a need for better expertise in CAM while others did not. Patients’ choice to decline cancer treatment was an ethical dilemma to most of the interviewed physicians. Even though communication in these situations tended to push some patients and physicians to take an extreme position, both parties wished for an open dialogue with mutual trust and understanding. The study protocol of Study III was designed and published according to the Standard Protocol Items for Clinical Trials (SPIRIT) guidelines. The trial started inclusion in 2016 and has been running at nine participating oncological departments. Inclusion was completed in December 2021 and expected end-of-study is September 2022. Thirty-one interviews have been conducted within the ancillary qualitative study and 100 patients were included in the biomarker study. Conclusions: Many patients with cancer use CAM, mainly as a complement to conventional treatment to improve wellbeing. Most have realistic expectations, express high satisfaction and awareness of side effects. In rare cases, patients decline conventional cancer treatment and use CAM as an alternative for complex reasons that are worthwhile to explore in concrete situations. Patients generally wish to stay in contact with cancer care but demand interest in and respect for their choices. The majority of CAM-using patients perceive a lack of knowledge about CAM among cancer care providers and do often not reveal their CAM use; however, patients want providers to be knowledgeable and able to give advice. Shared decision-making appears extra difficult in the clinically demanding situations when patients’ and physicians’ views on treatment choices profoundly diverge. Knowledge about CAM and competency in giving nuanced advice to interested patients seem crucial for an initiated patient-provider dialogue for safety reasons, patient satisfaction and mutual trust.  Both design and conduct of the RCT are an example of research filling an identified gap of knowledge and will provide cancer care with much-needed information. The design and conduct of this trial as well as its future results may serve as a model for CAM knowledge capacity building.  Evidence-based medicine is the practice of integrating individual clinical expertise and patient values with the best available external clinical evidence from systematic research. This thesis pays attention to patients’ values, builds professional competency and experience within CAM and acknowledges and contributes to systematic research. Bakgrund: Komplementär och alternativmedicin (KAM) är ett samlingsnamn för ett stort antal metoder som används parallellt med eller i stället för konventionell medicin. Kunskapen om svenska patienters användning av KAM parallellt med gängse behandling i samband med en cancersjukdom är begränsad. Kommunikation om KAM mellan patienter och vårdgivare är viktig. Gällande situationer där patienter avböjer erbjuden cancerbehandling och överväger att använda KAM i stället för erbjuden cancerbehandling finns det mycket lite forskning. En ofta använd KAM metod vid cancer är växtbaserade läkemedel framställda av mistel. En studie på mistelextrakt för patienter med framskriden bukspottkörtelcancer visade lovande resultat på förlängd överlevnad och livskvalitet. Med tanke på de begränsade behandlingsmöjligheterna vid denna sjukdom bör metoden prövas närmare. Mål: Målet med denna avhandling är att undersöka KAM användning både från patienters och läkares perspektiv och att designa en placebokontrollerad randomiserad klinisk studie för att utvärdera mistelextrakt som ett tillägg till standardbehandling för patienter med framskriden bukspottkörtelcancer. Metoder: Studie I är en tvärsnittsstudie på 755 patienter med solida tumörer; studien har en blandad metoddesign bestående av både kvantitativa och kvalitativa metoder. Studie II är en kvalitativ intervjustudie med sju patienter med cancer och tio läkare som arbetar inom cancervården. I Studie III har ett studieprotokoll för en multi­center, dubbelblind, randomiserad placebokontrollerad klinisk studie med parallella grupper designats. En blandad studiedesign används med två inbäddade substudier på en mindre mängd deltagare från huvudstudien med en translationell design i den ena substudien och en kvalitativ design i den andra. Patienter med framskriden bukspottkörtelcancer (n=290) har inkluderats i studien och mistelextrakt respektive placebo har givits under nio månader som tillägg till standardbehandling. Resultat: En av fyra patienter med cancer använde KAM som tillägg till konventionell behandling. De vanligaste motiven var förbättring av fysiskt, allmänt och emotionellt välbefinnande samt att stärka kroppens förmåga att bekämpa cancersjukdomen. Patienter var i regel mycket nöjda med sin KAM användning och biverkningar var få och milda. En tredjedel hade diskuterad KAM användning med sina vårdgivare inom cancervården. Mer än hälften av patienterna tyckte att man inom cancervården borde kunna svara på frågor om KAM och att vissa av dessa metoder borde rekommenderas och/eller erbjudas. Patienter som avböjde konventionell cancerbehandling hade olika skäl för sina val: många värdesatte KAM för ett bredare perspektiv på hälsa och sjukdom sett i en kroppslig, själslig och existentiell kontext. Ytterligare motiv inkluderade en önskan om ett eget aktivt ställningstagande i förhållande till behandlingsvalen och tidigare negativa erfarenheter från den konventionella vården. En del patienter kände sig inte respekterade i sina val och vittnade om brist på både kunskap och intresse från sina läkare. En del av de intervjuade läkarna beskrev ett behov av mer kompetens inom KAM. Patienters val att avböja cancerbehandlingen innebar ett etiskt dilemma för många av läkarna. Även om kommunikationen i dessa situationer kunde pressa både patienter och läkare till att inta en mer extrem position än de egentligen hade, så önskade sig ändå båda parter en öppen dialog med ömsesidigt förtroende och förståelse. Studieprotokollet i studie III är designat och publicerat i enlighet med SPIRIT riktlinjerna för studieprotokoll för kliniska studier. Studien började inkludera de första patienterna 2016 och har sedan dess pågått på sammanlagt nio deltagande onkologiska kliniker runtom i Sverige. I december 2021 inkluderades de sista deltagarna och studien beräknas slutföras under hösten 2022. I den kvalitativa substudien har 31 deltagare intervjuats och 100 deltagare har lämnat blodprover i den translationella substudien. Slutsatser: Många patienter med cancer använder KAM främst som ett tillägg till konventionell behandling för att förbättra sitt välbefinnande. Många har realistiska förväntningar, uttrycker en hög grad av nöjdhet och verkar vara uppmärksamma på biverkningar. I sällsynta fall avböjer patienter konventionell cancerbehandling och använder KAM som alternativ av komplexa anledningar som det är värt att reda ut i de konkreta situationerna. Generellt vill många av dessa patienter hålla kontakt med cancervården men önskar sig ett intresse från vårdens sida och respekt för sina val. De flesta av de KAM användande patienterna upplever en kunskapsbrist inom cancervården gällande KAM och berättar ofta inte om sin KAM användning. De flesta patienter önskar sig att vårdgivare ska ha kunskap om KAM och kunna ge råd. Delat beslutsfattande är extra svårt i de kliniskt krävande situationerna där patienters och läkares syn på behandlingsval går helt isär. Kunskap om KAM och kompetens att ge nyanserade råd till intresserade patienter verkar vara avgörande för en initierad dialog mellan patienter och vårdgivare både med tanke på patientsäkerhet, patientnöjdhet och ömsesidigt förtroende. Både designen och genomförandet av den randomiserade studien är exempel på forskning som fyller identifierade kunskapsluckor och kommer att förse cancervården med användbar information. Både de kommande resultaten av den kliniska studien och klinikernas deltagande i en studie om ett KAM preparat bidrar till ökad förståelse för specifika förutsättningar och frågeställningar inom området. Denna avhandling undersöker patienternas värderingar och ökar professionell kompetens och erfarenhet inom KAM samt visar på och bidrar till systematisk forskning. På detta sätt bidrar den till utvecklingen av en evidensbaserad medicin där individuell klinisk expertis och patienters värderingar integreras med den bästa tillgängliga vetenskapliga kunskapen från systematisk forskning.  Forskningsfinansiärer:Dagmar Ferbs Minnesfond,  projekt MISTRALGyllenbergs stiftelse, projektnummer 2014, 2018Onkologiska klinikens gåvofond, Karolinska Universitetssjukhuset, projektnummer K0777-2011Regionalt Cancer Centrum, projekt 2013, 2015</p

Komplementär och alternativ medicin vid cancer : från användning till en randomiserad kontrollerad studie

Background: Complementary and alternative medicine (CAM) are non-conventional health care approaches used in parallel with or instead of conventional medicine. Little is known about Swedish patients’ patterns of complementary CAM use in the context of cancer. Patient-provider communication concerning CAM is crucial and research about communication in situations when patients decline recommended cancer treatment and consider CAM as an alternative is scarce. One commonly used CAM approach is an herbal medicinal product from mistletoe. An open-label trial on mistletoe extract for patients with advanced pancreatic cancer reported promising results on overall survival and quality of life. Due to limited treatment options for this group of patients, this approach needs to be investigated further.  Aim: The overall aim of this thesis is to explore CAM use from patients’ and physicians’ perspectives and to design a placebo-controlled randomized clinical trial to assess mistletoe extract as a complement to standard treatment in patients with advanced pancreatic cancer.  Methods: A cross-sectional design with quantitative and qualitative mixed methods was used in Study I including 755 patients with solid tumors. In Study II a qualitative design with face-to-face interviews with seven patients with cancer and ten physicians from cancer care was used. In Study III, a study protocol for a multicenter, parallel group, double-blind, randomized, placebo-controlled clinical trial (RCT) was developed. Mixed methods were used by two nested ancillary studies on sub-sets of participants with a translational and a qualitative design respectively. Patients with advanced pancreatic cancer (n=290) were included; mistletoe extract/placebo was added to treatment of choice for the duration of nine months. The trial is currently being conducted.  Results: One of four patients with solid tumors used CAM parallel with conventional treatment. Main reasons motivations were the hope for improvement of physical, general, and emotional wellbeing and the body’s ability to fight cancer. Satisfaction with CAM usage was generally high; reported adverse effects few and mild. One third had discussed their CAM use with cancer care providers. More than half of the patients thought that cancer care providers should be able to discuss and/or consider use of CAM modalities in cancer care.  Patients declining conventional cancer treatment while using CAM had a variety of reasons for their choices: many of them valued CAM for a broader perspective on health and illness in the context of mind, body and spirit. The wish to take an active stance in relation to treatment decisions and previous negative experiences from conventional care were also cited as motives. Some patients felt a lack of respect for their choices and indicated lack of knowledge and interest on their physicians’ part. Some physicians felt a need for better expertise in CAM while others did not. Patients’ choice to decline cancer treatment was an ethical dilemma to most of the interviewed physicians. Even though communication in these situations tended to push some patients and physicians to take an extreme position, both parties wished for an open dialogue with mutual trust and understanding. The study protocol of Study III was designed and published according to the Standard Protocol Items for Clinical Trials (SPIRIT) guidelines. The trial started inclusion in 2016 and has been running at nine participating oncological departments. Inclusion was completed in December 2021 and expected end-of-study is September 2022. Thirty-one interviews have been conducted within the ancillary qualitative study and 100 patients were included in the biomarker study. Conclusions: Many patients with cancer use CAM, mainly as a complement to conventional treatment to improve wellbeing. Most have realistic expectations, express high satisfaction and awareness of side effects. In rare cases, patients decline conventional cancer treatment and use CAM as an alternative for complex reasons that are worthwhile to explore in concrete situations. Patients generally wish to stay in contact with cancer care but demand interest in and respect for their choices. The majority of CAM-using patients perceive a lack of knowledge about CAM among cancer care providers and do often not reveal their CAM use; however, patients want providers to be knowledgeable and able to give advice. Shared decision-making appears extra difficult in the clinically demanding situations when patients’ and physicians’ views on treatment choices profoundly diverge. Knowledge about CAM and competency in giving nuanced advice to interested patients seem crucial for an initiated patient-provider dialogue for safety reasons, patient satisfaction and mutual trust.  Both design and conduct of the RCT are an example of research filling an identified gap of knowledge and will provide cancer care with much-needed information. The design and conduct of this trial as well as its future results may serve as a model for CAM knowledge capacity building.  Evidence-based medicine is the practice of integrating individual clinical expertise and patient values with the best available external clinical evidence from systematic research. This thesis pays attention to patients’ values, builds professional competency and experience within CAM and acknowledges and contributes to systematic research. Bakgrund: Komplementär och alternativmedicin (KAM) är ett samlingsnamn för ett stort antal metoder som används parallellt med eller i stället för konventionell medicin. Kunskapen om svenska patienters användning av KAM parallellt med gängse behandling i samband med en cancersjukdom är begränsad. Kommunikation om KAM mellan patienter och vårdgivare är viktig. Gällande situationer där patienter avböjer erbjuden cancerbehandling och överväger att använda KAM i stället för erbjuden cancerbehandling finns det mycket lite forskning. En ofta använd KAM metod vid cancer är växtbaserade läkemedel framställda av mistel. En studie på mistelextrakt för patienter med framskriden bukspottkörtelcancer visade lovande resultat på förlängd överlevnad och livskvalitet. Med tanke på de begränsade behandlingsmöjligheterna vid denna sjukdom bör metoden prövas närmare. Mål: Målet med denna avhandling är att undersöka KAM användning både från patienters och läkares perspektiv och att designa en placebokontrollerad randomiserad klinisk studie för att utvärdera mistelextrakt som ett tillägg till standardbehandling för patienter med framskriden bukspottkörtelcancer. Metoder: Studie I är en tvärsnittsstudie på 755 patienter med solida tumörer; studien har en blandad metoddesign bestående av både kvantitativa och kvalitativa metoder. Studie II är en kvalitativ intervjustudie med sju patienter med cancer och tio läkare som arbetar inom cancervården. I Studie III har ett studieprotokoll för en multi­center, dubbelblind, randomiserad placebokontrollerad klinisk studie med parallella grupper designats. En blandad studiedesign används med två inbäddade substudier på en mindre mängd deltagare från huvudstudien med en translationell design i den ena substudien och en kvalitativ design i den andra. Patienter med framskriden bukspottkörtelcancer (n=290) har inkluderats i studien och mistelextrakt respektive placebo har givits under nio månader som tillägg till standardbehandling. Resultat: En av fyra patienter med cancer använde KAM som tillägg till konventionell behandling. De vanligaste motiven var förbättring av fysiskt, allmänt och emotionellt välbefinnande samt att stärka kroppens förmåga att bekämpa cancersjukdomen. Patienter var i regel mycket nöjda med sin KAM användning och biverkningar var få och milda. En tredjedel hade diskuterad KAM användning med sina vårdgivare inom cancervården. Mer än hälften av patienterna tyckte att man inom cancervården borde kunna svara på frågor om KAM och att vissa av dessa metoder borde rekommenderas och/eller erbjudas. Patienter som avböjde konventionell cancerbehandling hade olika skäl för sina val: många värdesatte KAM för ett bredare perspektiv på hälsa och sjukdom sett i en kroppslig, själslig och existentiell kontext. Ytterligare motiv inkluderade en önskan om ett eget aktivt ställningstagande i förhållande till behandlingsvalen och tidigare negativa erfarenheter från den konventionella vården. En del patienter kände sig inte respekterade i sina val och vittnade om brist på både kunskap och intresse från sina läkare. En del av de intervjuade läkarna beskrev ett behov av mer kompetens inom KAM. Patienters val att avböja cancerbehandlingen innebar ett etiskt dilemma för många av läkarna. Även om kommunikationen i dessa situationer kunde pressa både patienter och läkare till att inta en mer extrem position än de egentligen hade, så önskade sig ändå båda parter en öppen dialog med ömsesidigt förtroende och förståelse. Studieprotokollet i studie III är designat och publicerat i enlighet med SPIRIT riktlinjerna för studieprotokoll för kliniska studier. Studien började inkludera de första patienterna 2016 och har sedan dess pågått på sammanlagt nio deltagande onkologiska kliniker runtom i Sverige. I december 2021 inkluderades de sista deltagarna och studien beräknas slutföras under hösten 2022. I den kvalitativa substudien har 31 deltagare intervjuats och 100 deltagare har lämnat blodprover i den translationella substudien. Slutsatser: Många patienter med cancer använder KAM främst som ett tillägg till konventionell behandling för att förbättra sitt välbefinnande. Många har realistiska förväntningar, uttrycker en hög grad av nöjdhet och verkar vara uppmärksamma på biverkningar. I sällsynta fall avböjer patienter konventionell cancerbehandling och använder KAM som alternativ av komplexa anledningar som det är värt att reda ut i de konkreta situationerna. Generellt vill många av dessa patienter hålla kontakt med cancervården men önskar sig ett intresse från vårdens sida och respekt för sina val. De flesta av de KAM användande patienterna upplever en kunskapsbrist inom cancervården gällande KAM och berättar ofta inte om sin KAM användning. De flesta patienter önskar sig att vårdgivare ska ha kunskap om KAM och kunna ge råd. Delat beslutsfattande är extra svårt i de kliniskt krävande situationerna där patienters och läkares syn på behandlingsval går helt isär. Kunskap om KAM och kompetens att ge nyanserade råd till intresserade patienter verkar vara avgörande för en initierad dialog mellan patienter och vårdgivare både med tanke på patientsäkerhet, patientnöjdhet och ömsesidigt förtroende. Både designen och genomförandet av den randomiserade studien är exempel på forskning som fyller identifierade kunskapsluckor och kommer att förse cancervården med användbar information. Både de kommande resultaten av den kliniska studien och klinikernas deltagande i en studie om ett KAM preparat bidrar till ökad förståelse för specifika förutsättningar och frågeställningar inom området. Denna avhandling undersöker patienternas värderingar och ökar professionell kompetens och erfarenhet inom KAM samt visar på och bidrar till systematisk forskning. På detta sätt bidrar den till utvecklingen av en evidensbaserad medicin där individuell klinisk expertis och patienters värderingar integreras med den bästa tillgängliga vetenskapliga kunskapen från systematisk forskning.  Forskningsfinansiärer:Dagmar Ferbs Minnesfond,  projekt MISTRALGyllenbergs stiftelse, projektnummer 2014, 2018Onkologiska klinikens gåvofond, Karolinska Universitetssjukhuset, projektnummer K0777-2011Regionalt Cancer Centrum, projekt 2013, 2015</p

Communication about complementary and alternative medicine when patients decline conventional cancer treatment : patients' and physicians' experiences

Background: Complementary and alternative medicine (CAM) is a broad set of nonconventional practices used alongside or instead of conventional treatment: The latter poses obvious risks related to cancer prognosis. Patient-physician dialogue about CAM is crucial for patient safety and mutual trust. Little is known about communication in the rare situations when patients decline recommended cancer treatment and consider using CAM. The objective of this study was to explore patients' and physicians' experiences from situations when patients decline recommended cancer treatment and consider using CAM. Materials and methods: Semi-structured interviews were carried out with 7 CAM-using cancer patients who had declined some or all conventional treatment as well as 10 physicians from oncology and palliative care. Framework analysis was used. Results: Regarding treatment choices, there was a dissonance between physicians' focus on medical reasoning and patients' expression of complex values. Physicians' difficulty in understanding patients' treatment decline was exacerbated when patients considered using CAM, impairing communication even further. Inequalities in roles resulting in power struggles risked pushing both parties toward extreme and inflexible standpoints. Despite these challenges regarding treatment choices and hierarchical roles, both parties considered open and respectful communication as crucial. Conclusions: This study highlights the difficulty of shared decision-making in practice when patients' and physicians' views on treatment decisions deviate in clinically challenging situations. Our results point to a need to address the complexity of these situations, pay attention to patients' values, and improve knowledge among physicians about CAM.Originally included in thesis in manuscript form. </p

Cancer patients’ use of complementary and alternative medicine in Sweden: a cross-sectional study

Abstract Background Access to and advice on Complementary and Alternative Medicine (CAM) are uncommon within Swedish conventional cancer care and little is known about cancer patients’ own use of CAM. The aim of this cross-sectional study was to explore Swedish cancer patients´ patterns of CAM use, their experiences and preferences. Methods Questionnaires were distributed consecutively to 1297 cancer patients at a university hospital’s out-patient oncology units. The response rate was 58% (n = 755). Descriptive statistics were used to analyze the survey data. A logistic regression model was used to investigate the association between CAM use and gender, age and level of education. Open-ended responses were analyzed, using qualitative content analysis. Results Lifetime CAM use was reported by 34% (n = 256), and 26% (n = 198) used CAM after cancer diagnosis. Being female, younger and having higher education predicted CAM use. Most commonly used methods were natural products including vitamins and minerals and relaxation. Main reasons for CAM use were improvement of physical, general and emotional wellbeing and increasing the body’s ability to fight cancer. Satisfaction with CAM usage was generally high. Reported adverse effects were few and mild; 54% of users spent < 50 Euro a month on CAM. One third had discussed their CAM use with cancer care providers. More than half of all participants thought that cancer care providers should be able to discuss (58%) and to consider (54%) use of CAM modalities in cancer care. Conclusions Despite limited access and advice within conventional cancer care, one fourth of Swedish cancer patients use CAM. The insufficient patient-provider dialogue diverges with most patients’ wish for professional guidance in their decisions and integration of CAM modalities in conventional cancer care. Concurrent and multimodal CAM use implies challenges and possibilities for cancer care that need to be considered

Use of CAM among cancer patients : results of a regional survey in Sweden

Background: The use of complementary and alternative medicine (CAM) by patients is widespread. However, there is a lack of knowledge regarding the extent and details of patient CAM use in Sweden, especially in rural Sweden. The aim of this study was to estimate the extent and characteristics of CAM use among cancer patients in Region Gävleborg. Methods: A total of 631 questionnaires were distributed to which 376 responses were registered, yielding a response rate of 59.6%. Questionnaires were distributed to oncology patients at their first visit for curative treatment at the Department of Oncology, Gävle Hospital. Palliative patients were recruited at their first visit and during enrollment in palliative outpatient care in their own homes. The characteristics of the respondents were presented with standard descriptive statistics. A multivariable logistic model was fitted to calculate odds ratios (ORs) and identify potential predictors (Age, Gender, Education, Diagnosis) of CAM use post-cancer diagnosis. Results: 54% of all participants reported lifetime CAM use, 34% reported CAM use post-diagnosis. The most common CAM methods used after diagnosis are vitamins, health food preparations, herbal teas, prayer and dietary methods. The most common source of information reported is family and friends. Almost 70% of those who used CAM after their diagnosis stated that they did not discuss their use with healthcare professionals. Most patients reported that they would like some CAM modalities to be offered within conventional care regardless of their own CAM use. Conclusions: The use of CAM is common among patients with cancer in the region of Gävleborg, and previous studies show a similar use in Sweden in general. Based on the widespread use of CAM and patient interest in discussing CAM use with healthcare professionals, greater attention and focus should be placed on creating a basis for this dialogue. If we, as healthcare professionals, are to emphasise our commitment to providing patient-centred care, we must acknowledge that patients use CAM and are seeking a dialogue about CAM use in their care

Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer : study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)

BackgroundMost pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported.The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.MethodsThe trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews.DiscussionTo our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer.Trial registrationEU Clinical Trial Register, EudraCT Number 2014-004552-64. Registered on 19 January 2016.ClinicalTrials.gov NCT02948309. Registered on 28 October 2016

Strategies for Prevention and Treatment of COVID-19 related Symptoms. A Population Based Cross-sectional Study in Norway, Sweden and the Netherlands

Objectives: The present study was initiated to determine consultations with health care providers and use of selfmanagement strategies for prevention or treatment of COVID-19 related symptoms in countries with a full lockdown (Norway), a partial lockdown (the Netherlands) and no lockdown (Sweden) during the first three months of the COVID-19 pandemic, and if such use correlates with worries of being infected by COVID-19 disease. Design: Data were collected in collaboration with Ipsos A/S in April-June 2020. An adapted version of the International Questionnaire to measure use of Complementary and Alternative Medicine (I-CAM-Q) was used with the categories “for prevention of COVID-19” and “to treat COVID-19-related symptoms” added. Data were collected among a representative sample in Norway, Sweden and the Netherlands using data assisted telephone interviews (Norway, n=990 and Sweden, n=500), and an online survey (the Netherlands, n=1004). Total response rate was 30%. Results: Very few consulted a health care provider with the intention to treat or prevent COVID-19 (1.2% and 1.0% respectively) with medical doctors mostly visited (1.0% and 0.9% respectively). Similarly, the use of selfmanagement strategies to prevent or treat COVID-19 was low (3.4% and 0.2% respectively); most commonly used for prevention of COVID-19 were vitamins and minerals (2.8%). Consultations with health care providers and use of self-management strategies for prevention of COVID-19 were positively associated with worries of being infected with COVID-19. Conclusions: The COVID-19 pandemic does not seem to have evoked a large-scale difference in behavior related to consultations with health care providers or the use of self-management strategies in any of the three countries