Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Malnutrition

Nutrition Disorders

Quality of Life

The control group is not offered any home food-delivery service, but continues with their habitual diet

The intervention group is offered home food-delivery service

A home food-delivery service is offered the intervention group of cancer patients

Home food-delivery service

Arne V Astrup, Professor

Eva Leedo, Cand Scient

The overall objective of the study is to investigate the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished patients suffering from cancer on various endpoints.

Despite the fact that nutritional deterioration has been associated with patients' functional impairment, the effect of individualized nutritional support or counselling to outpatients, focussing on ordinary food, have not yet been thoroughly explored (Ravasco P. et al. 2007). A few studies have investigated the effect of nutritional counselling on quality of life (QoL) in cancer patients after discharge (Ovesen et al. 1993, Persson et al. 2002, Isenring et al. 2004, Ravasco et al. 2005a, Ravasco et al. 2005b). However, there is to our knowledge not conducted any studies examining the effect of home delivered meals on QoL and other endpoints in outpatients suffering from cancer.

The overall objective of the study is to measure the effect of energy- and protein enriched home delivered meals vs. habitual diet in malnourished outpatients diagnosed with lung cancer. The intervention diet will consist of optional protein- and energy-dense main and in-between-meals. There will be 22 different main meals and 13 in-between meals to choose between. The meals are prepared by The Nordic Kitchen of Copenhagen University Hospital Herlev. The offered main meals will consist of a selection of warm dishes taken from the ordinary menu. The in-between meals are a collection of the Delights of Herlev (dishes previously shown to increase dietary intake among in-patients). The food will be delivered to the participants' home 3 times per week, and participants can order one warm dish and ad libitum in-between meals for each day.

Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients

Meals on Wheels, a Randomized Controlled Study on the Effect of a Home Food-delivery Service for Cancer Patients

All patients in the intervention group are requested to daily fulfil a compliance sheet during the whole 12-week period, where the intake of intervention dishes will be recorded. Project staff will review the completed sheets together with the study participant at mid-way (week 6) and at the final 12-week visit in order to minimize possible uncertainties. Moreover, eventual side-effects and reasons for non-compliance will be recorded.

All the intervention participants will receive an evaluation form in order to assess the acceptability of the offered meals, the food-delivery service, and a possible price they would give for this particular food-delivery service.

Definition of social status: if the participant is living alone or not

To assess the Global QoL, a questionnaire from the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-30, version 3, will be used. This is a validated, cancer-specific questionnaire with a total of 30 questions, looking back at the past week. The scoring of QoL is based on 2 specific questions with response options ranging from 1-7 which indicate very bad to very good. A Danish version of the questionnaire will be used.

Hand grip strength (in kg) will be measured with a Hydraulic Hand Dynamometer. Participants will be seated with forearms rested on the arms of the chair. They are asked to perform three maximum force trials with their dominant hand and using the second handle position. The test will be repeated within 30 seconds, and the maximum grip score from the three measured values will be used.

The 30-second-chair-stand test consist of manually counting the number of sit-stand-sit cycles completed during the 30 seconds of the test. A standard chair (with a seat height of 40cm) with or without a backrest but with armrests will be used. Initially, subject will be seated on the chair with their back in an upright position. They will be instructed to rise after the "1, 2, 3, go" command at their own preferred speed with their arms folded across their chest. If the participant is only able to perform the test by using armrest, the test will be recorded as "modified".

Body weight will be measured to the nearest 0.1 kg following standard procedures (i.e. without shoes, minimal clothing).

The Center for Epidemiological Studies Depression scale (CES-D) is a short self-report scale designed to measure depressive symptoms (Hann D. et al. 1999). The questionnaire contains 20 items, divided in four domains: Somatic Retarded Activity (7 items), Depressed Affect (5 items), Positive Affect (4 items), and Interpersonal Affect (2 items), and 2 single items that complete the total score. The total score ranges from 0 to 60; a score of ≥16 indicates a depressed symptomatology. The CES-D has been validated in several samples of cancer patients, and it is often administered to inpatients with cancer (Vodermaier A. et al. 2009). A Danish version of the questionnaire will be used.

Dietary intake will be assessed by a dietary interview covering patient's dietary intake over the past week. On basis of the dietary interview the total energy and protein intake per day is estimated. A food database with energy- and protein content of various foods is used for the estimation.

Data on re-admissions to the hospital and LOS will be collected from all participants medical charts (hospital medical system OPUS/GS).

Data on mortality will be collected from all participants' medical charts (hospital medical system OPUS/GS).

Using EORTC-QLQ-30 version 3 - looking back at the past week. Out of the 30 questions the functional score is based on 15 specific questions with 4 response options indicating either: not at all, a little, some or a lot. Involves questions related to physical-, role-, emotional-, cognitive- and social functioning.

Using EORTC-QLQ-30 version 3 - looking back at the past week. Out of the 30 questions the symptom score is based on 13 specific questions with 4 response options indicating either: not at all, a little, some or a lot.

Copenhagen University Hospital at Herlev

Head of Reseach

Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers

Standard care including information about treatment, potential side effects and expected symptoms under treatment with or without additional written material following the established procedure at the centre.

Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home.

Symptom Navi© Program

Manuela Eicher, Prof. Dr.

The Symptom Navi© Program is a program to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units.The current study aims to pilot test the implementation of the Symptom Navi© Program under real-life conditions by evaluating procedures, testing preliminary effectiveness and assessing potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods.

Patients treated in cancer outpatient settings in Switzerland have high unmet care needs, especially in the domain of self-management of symptoms. The Symptom Navi© Program was developed to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units. The acceptability and feasibility of the Symptom Navi© Program was supported by a qualitative study with 10 cancer patients who received semi-structured patient consultations and subsequently used the Symptom Navi© Flyers at home.

The overall objective of the current study is to pilot test the implementation of the Symptom Navi© Program under real-life conditions. The aims are to evaluate procedures, to test preliminary effectiveness and to assess potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods. The unit of randomization are the participating cancer outpatient centres with each centre representing a cluster. Intervention cluster will provide the Symptom Navi© Program, control clusters will provide usual care for symptom-management.

Implementation of the Symptom Navi© Program

Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)

Symptom interference with daily function in the affective and activity subdimension scores of the MD Anderson Symptom Inventory (MDASI)

Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G)

Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI)

Quality of nursing care assessed by the Patient-Reported Chemotherapy Indicators of Symptoms and Experiences (PR-CISE)

Manuela Eicher

Prof. Dr.

Symptoms and General Pathology

Pain

Analgesics

All Drugs and Chemicals

Two in-home visits (60 minutes) with at least weekly follow-up (visit or telephone call according to algorithm): Structured and tailored components; review of pain diary with participant, provision of information on pain medication, nurse coaching regarding pain self-management, detailed side-effect management plan, if distressing side-effects arise, re-evaluation together with participant at each subsequent visit.

Elisabeth Spichiger, PhD

Horst Rettke, PhD

Background: Up to 64% of cancer patients experience pain, and as many as 40% of patients with pain do not receive adequate pain management. And while potential to reduce pain has been shown in several interventions that support patients' self-management, effects have been moderate. Purpose: This multicenter mixed methods study primarily aims to evaluate the efficacy of the adapted German PRO-SELF© Plus Pain Control Program (PCP) on pain intensity, to explore the intervention's effect on associated symptoms and other patient and family caregiver (FC) outcomes, and to explore patients' and FCs' experiences with cancer pain management.

Methods: A nested concurrent mixed methods design will be used for this multi-center study, that is, a randomized controlled trial (RCT) will be combined with a qualitative substudy. Participants will be randomly assigned to a 6-week intervention or usual care group; outcomes will be evaluated at 6 weeks post-randomization. The primary outcome will be pain intensity. A total sample of 210 patients with cancer pain and approximately 105 FCs will be recruited from the oncology outpatient clinics of the University Hospitals Basel, Zurich and Bern. The intervention is designed to implement structured and tailored components (information, skill-building, nurse coaching) and aims at improving patients' pain self-management. Data analysis will follow an intent-to-treat strategy and generalized mixed models will be used. For the qualitative substudy, 60 patients and FCs of both groups will be interviewed. Data will be systematically summarized.

Background: Between 33% and 64% of cancer patients experience pain; however, despite effective treatment options, as many as 40% of patients with pain do not receive adequate pain management. And while potential to reduce pain has been shown in several interventions that support patients' self-management of cancer pain, effects to date have been moderate. However, in a recent randomized controlled trial (RCT), Miaskowski's PRO-SELF© Pain Control Program (PCP) showed statistically and clinically significant pain reduction. This intervention was subsequently adapted for a second trial as PRO SELF© Plus PCP. The planned multi-center mixed methods study is based on this earlier work. In our previous pilot study, the PRO-SELF© Plus PCP was translated and adapted for a German speaking population. The feasibility of the intervention and study procedures was established and the intervention enhanced based on the pilot study's implications.

Purpose: This multi-center mixed methods study aims (1) to evaluate the efficacy of the adapted German PRO-SELF© Plus PCP, designed to improve outpatients' and their family caregivers' (FCs) management of pain on pain intensity; (2) to explore the intervention's effect on associated symptoms and other patient and FC outcomes; (3) to explore patients' and FCs' experiences with cancer pain management in both the intervention group and the usual care group; and (4) to interpret quantitative and qualitative findings and eventually synthesize them. To our knowledge, this will be the first evaluation of an intervention to support pain self-management in German speaking outpatients with cancer related pain and their FCs.

Methods: A nested concurrent mixed methods design will be used for this multi-center study, that is, an RCT will be combined with a qualitative substudy. Participants will complete a baseline evaluation, after which they will be randomly assigned to a 6-week intervention or usual care group. Blinding of data collectors is not feasible. Participants in both groups will complete a daily pain and symptom diary; other outcomes will be evaluated at 6 weeks post-randomization. The primary outcome of this study will be average and worst pain intensity. A total sample of 210 patients with cancer pain and approximately 105 FCs will be recruited from the oncology outpatient clinics of the University Hospitals Basel, Zurich and Bern. The intervention is designed to implement structured and tailored components (information, skill-building, nurse coaching) of the German PRO-SELF© Plus PCP. Participants will receive weekly in-home or telephone visits. Data analysis will follow an intent-to-treat strategy and generalized mixed models will be used. Average per-patient costs for the intervention will be calculated. For the qualitative substudy, approximately 7-10 patients and FCs per group and site will be interviewed regarding their experiences with pain management and intervention. Interpretive description will be used, including stepwise, systematic and iterative processing of data, leading to a meaningful description and interpretation.

Significance: The planned RCT will test the efficacy of the adapted German PRO-SELF© Plus PCP, with findings from the qualitative substudy providing additional insights. Qualitative results will support the interpretation of quantitative results and vice versa. If efficacious in decreasing average and worst pain in patients with cancer by improving patients' and FCs' pain self-management, the adapted German PRO-SELF© Plus PCP could be adapted to and implemented in clinical practice. Specially trained oncology nurses in outpatient clinics and home care organizations could apply the intervention as needed.

Study to Test the Efficacy of the PRO-SELF® Plus Pain Control Program to Reduce Pain in Outpatients With Cancer

Mixed Methods Study to Test the Efficacy of the Adapted German PRO-SELF® Plus Pain Control Program, an Intervention Directed at Outpatients With Cancer and Their Family Caregivers to Reduce Pain and Related Symptoms

Measurement of Change in pain intensity using a numeric rating scale, 0-10,with 0 = no pain, 10 = worst imaginable pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients	NCT02093312	Lung Cancer Ambulant Malnourished	Home food-deliv...	-	Copenhagen University Hospital at Herlev
Meals on Wheels, the Effect of a Home Food-delivery Service for Cancer Patients	NCT02093312	Lung Cancer Ambulant Malnourished	Home food-deliv...	-	Copenhagen University Hospital at Herlev
Implementation of the Symptom Navi© Program	NCT03649984	Cancer	Symptom Navi© P...	18 Years -	University of Lausanne
Study to Test the Efficacy of the PRO-SELF® Plus Pain Control Program to Reduce Pain in Outpatients With Cancer	NCT02713919	Pain Management	Adapted German ...	18 Years -	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for outpatients

Every month we try and update this database with for outpatients cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for outpatients

Every month we try and update this database with for outpatients cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for outpatients cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.