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Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial.

ABSTRACT: Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings.We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline.Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients.ClinicalTrials.gov NCT02051660.

SUBMITTER: Scheffold K

PROVIDER: S-EPMC4545321 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial.

Scheffold Katharina K Philipp Rebecca R Engelmann Dorit D Schulz-Kindermann Frank F Rosenberger Christina C Oechsle Karin K Härter Martin M Wegscheider Karl K Lordick Florian F Lo Chris C Hales Sarah S Rodin Gary G Mehnert Anja A

BMC cancer 20150819

<h4>Background</h4>Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy f ...[more]

PMID: 26286128

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Project description:BackgroundWe have developed a novel and brief semi-structured psychotherapeutic intervention for patients with advanced or metastatic cancer, called Managing Cancer And Living Meaningfully. We describe here the methodology of a randomized controlled trial to test the efficacy of this treatment to alleviate distress and promote well-being in this population.Methods/designThe study is an unblinded randomized controlled trial with 2 conditions (intervention plus usual care versus usual care alone) and assessments at baseline, 3 and 6 months. The site is the Princess Margaret Cancer Centre, part of the University Health Network, in Toronto, Canada. Eligibility criteria include: ≥ 18 years of age; English fluency; no cognitive impairment; and diagnosis of advanced cancer. The 3-6 session intervention is manualized and allows for flexibility to meet individual patients' needs. It is delivered over a 3-6 month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. Usual care at the Princess Margaret Cancer Centre includes distress screening and referral as required to in-hospital psychosocial and palliative care services. The primary outcome is frequency of depressive symptoms and the primary endpoint is at 3 months. Secondary outcomes include diagnosis of major or minor depression, generalized anxiety, death anxiety, spiritual well-being, quality of life, demoralization, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.DiscussionManaging Cancer And Living Meaningfully has the potential to relieve distress and promote psychological well-being in patients with advanced cancer and their primary caregivers. This trial is being conducted to determine its benefit and inform its dissemination. The intervention has cross-national relevance and training workshops have been held thus far with clinicians from North and South America, Europe, the Middle East, Asia and Africa.Trial registrationClinicalTrials.gov NCT01506492 4 January 2012.

Project description:IntroductionThe Managing Cancer and Living Meaningfully (CALM) therapy for patients with advanced cancer was tested against a supportive psycho-oncological counseling intervention (SPI) in a randomized controlled trial (RCT). We investigated whether CALM was delivered as intended (therapists' adherence); whether CALM therapists with less experience in psycho-oncological care show higher adherence scores; and whether potential overlapping treatment elements between CALM and SPI can be identified (treatment differentiation).MethodsTwo trained and blinded raters assessed on 19 items four subscales of the Treatment Integrity Scale covering treatment domains of CALM (SC: Symptom Management and Communication with Health Care Providers; CSR: Changes in Self and Relationship with Others; SMP: Spiritual Well-being and Sense of Meaning and Purpose; FHM: Preparing for the Future, Sustaining Hope and Facing Mortality). A random sample of 150 audio recordings (75 CALM, 75 SPI) were rated on a three-point Likert scale with 1 = "adherent to some extent," 2 = "adherent to a sufficient extent," 3 = "very adherent."ResultsAll 19 treatment elements were applied, but in various frequencies. CALM therapists most frequently explored symptoms and/or relationship to health care providers (SC_1: n_applied = 62; 83%) and allowed expression of sadness and anxiety about the progression of disease (FHM_2: n_applied = 62; 83%). The exploration of CALM treatment element SC_1 was most frequently implemented in a satisfactory or excellent manner (n_sufficient or very adherent = 34; 45%), whereas the treatment element SMP_4: Therapist promotes acknowledgment that some life goals may no longer be achievable (n_sufficient or very adherent = 0; 0%) was not implemented in a satisfactory manner. In terms of treatment differentiation, no treatment elements could be identified which were applied significantly more often by CALM therapists than by SPI therapists.ConclusionResults verify the application of CALM treatment domains. However, CALM therapists' adherence scores indicated manual deviations. Furthermore, raters were not able to significantly distinguish CALM from SPI, implying that overlapping treatment elements were delivered to patients.

Project description:IntroductionRegardless of the healthcare setting, person-centred care and its implementation in caring for older people are a central issue for those who are responsible as professional caregivers and for those in need of care within the care process. Both aspects encompass the possibility of recognising personal preferences. To provide person-centred care, professional caregivers need to know about the individual preferences of the persons being cared for. Therefore, the PELI (an acronym for 'Preferences for Everyday Living Inventory') instrument was developed at the Polisher Research Institute (USA) for the systematic recording of individual preferences of older people in need of care. There is currently no comparable instrument available in the German language.MethodsAs part of the proposed project PELI-D, all versions of the original PELI instrument (nursing home version) were (1) culture-sensitively translated into German and will be (2) examined in a pilot study for their reliability, feasibility and practicability. For the project PELI-D, we worked together with our practice partners in Germany (Diaconia and Caritas in North Rhine-Westphalia) and collaborated with our partners in the USA who developed the PELI instrument. This study protocol focuses on the pilot study, which will be conducted by the German Center for Neurodegenerative Diseases (DZNE) (site Witten).Ethics and disseminationThis study was approved by the internal quality control committee of the DZNE (ID number: WI029 PELI-D) and by the ethics committee of the German Society of Nursing Science Duisburg branch office (ID number: 18-010). All personal information will be deidentified with a specific identification code and stored in a secured location apart from the rest of the study data. Only qualified and study-related staff will be allowed access to the data. The results of the study will be distributed nationally and internationally through peer-reviewed journals, conferences and journals for nursing care practice.

Dataset Information

Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial.

Publications

Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial.

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