Exercise and Nutrition for Head and Neck Cancer Patients (ENHANCE)
24 października 2016 zaktualizowane przez: Dr. Nicole Culos-Reed, University of Calgary
Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations.
This translates into a lack of clinical programming available for these patient populations.
Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning.
To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes.
A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population.
Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program.
Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life.
In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work.
The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs.
delayed) as well as in those who receive the maintenance program (vs.
no maintenance).
This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Alberta
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Calgary, Alberta, Kanada, T2N4N2
- Tom Baker Cancer Centre
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Calgary, Alberta, Kanada, T2N1N4
- University of Calgary
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Over 18 Years of Age
- Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
- Will receive radiation as part of treatment plan
- Able to walk without assistance
- Received clearance for exercise from treating oncologist
- Lives in Calgary, Alberta area
- Can speak and write English
- Is interested in participating in the study
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Immediate Lifestyle Intervention - Maintenance Program
Patients will receive a 12-week lifestyle program during treatment.
Patients will also receive maintenance support following the 12-week program.
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Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
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Eksperymentalny: Immediate Lifestyle Intervention - No Maintenance Program
Patients will begin the 12-week lifestyle intervention during treatment.
Patients will not receive a maintenance support following the 12-week intervention.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
|
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Eksperymentalny: Delayed Lifestyle Intervention - Maintenance Program
Patients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis).
Patients will then receive maintenance support following the 12-week program.
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Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
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Eksperymentalny: Delayed Lifestyle Intervention - No Maintenance Program
Patients will receive a 12-week lifestyle intervention program following treatment completion (12 weeks following diagnosis).
Patients will not receive maintenance support following the 12-week program.
|
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week.
In addition, participants will be required to attend six education sessions during the 12-week intervention.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Body Composition
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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DXA Scan will be used to assess body composition
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of Life
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Quality of Life will be assessed using the Functional Assessment of Cancer Therapy- Anemia module (FACT-AN), and the NCCN-FACT Fact Head/Neck Symptom Index-22 (FHNSI-22).
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Physical Activity Behaviour
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Physical activity will be assessed using Godin's (Godin, 1985) leisure score index (LSI) of the GLTEQ (Godin Leisure Time Exercise Questionnaire).
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Smoking History
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Smoking history will be assessed by a self report questionnaire which will classify patients as non-smokers, former smokers and current smokers.
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Depression
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Depression will be assessed using the Center for Epidemiological Studies on Depression Scale (CES-D).
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Karnofsky Performance Score (KPS)
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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The Karnofsky Performance Score (KSP) will be used to measure the participant's general ability to accomplish tasks of daily-living and overall well-being.
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Inflammatory Markers
Ramy czasowe: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Inflammatory factors will be evaluated as they are associated with cancer cachexia and muscle wasting and may be modified by exercise (Seruga et al., 2008; Baldwin, 2011).
An overnight fasted blood draw will be collected at baseline, 3 months post diagnosis, 6 months post diagnosis, 9 months post diagnosis, and 12 months post diagnosis.
Serum inflammatory cytokine concentrations will be assessed in-house (Dr.
Raylene Reimer's laboratory) according to our established protocols.
TNF, IL-6, IL-1, IL-8 and C-reactive protein will be quantified using Milliplex Human Cytokine kits (Millipore, Billerica, MA).
Plate reading will be provided as a fee-for service through Eve Technologies Inc. (Calgary, AB).
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At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
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Cancer related Symptom Management
Ramy czasowe: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
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Participants will complete the ESAS bi-weekly, before and after class.
The ESAS is a valid and reliable assessment tool to evaluate the nine more common symptoms experienced by cancer patients (Chang et al., 2000).
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At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
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Diet Behaviour - 3 Day food record
Ramy czasowe: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
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The 3-Day Diet Record is said to be the most accurate for mean macronutrient content and appropriate for use in studies where subjects may consume a wide variety of foods (American Dietetics Association / Dietitians Canada, 2000).
Participants are instructed to record their daily consumption over a period of three days, one of which must be a weekend day.
Written instructions and a sample entry are provided to increase accuracy of the daily record.
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At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
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Diet Behaviour: PG-SGA
Ramy czasowe: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
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The PG-SGA assessment tool has been show to improve treatment outcomes, decrease side-effects, and improve weight-management in cancer patients, and therefore will be used weekly to assess and identify malnutrition among patients (McMahon et al., 2000; Doyle et al., 2006).
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At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
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Health related Fitness Measures - Resting Heart Rate
Ramy czasowe: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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Resting heart rate will be measured by palpating the radial artery and taking a 15 second count as per the CPAFLA protocol (CPAFLA, 2003).
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At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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Health Related Fitness Outcome - Blood Pressure
Ramy czasowe: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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A resting blood pressure (mmHg) will be measured in duplicate on the left arm using a sphygmomanometer and stethoscope using standardized procedures (CPAFLA, 2003).
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At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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Health Related Fitness Outcome - 6 minute walk test
Ramy czasowe: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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The six-minute walk test (6MWT) will be used to assess changes in functional aerobic capacity.
Using the standardized protocol, participants will be asked to walk as far as they can around a 400-meter track for six minutes [43].
The point reached at 6 minutes will be marked and measured to the nearest 0.5 meter.
Rating of perceived exertion (Borg scale) will be completed immediately after completion of the functional aerobic capacity test.
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At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
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Health Related Fitness Outcome - Grip Strength
Ramy czasowe: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
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Muscular strength will be assessed using a combined grip strength of the right and left hands will also be assessed using a hand dynamometer.
A sum will be determined in kilograms from the best score of 2 trials recorded for each hand according to the CPAFLA protocol.
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At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
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Health Related Fitness Outcome - Lower Body Strength
Ramy czasowe: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
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Lower body strength will be assessed using a 30-second sit to stand test.
The number of times participants can stand from a seated position in 30-second will be examined.
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At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
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Health Related Fitness Outcome - Flexibility
Ramy czasowe: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
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Flexibility will be assessed by a trunk forward flexion sit-and-reach test using a Wells-Dillon flexometer.
The test will follow a standard protocol, with two trials allowed and the highest score to the nearest 0.5 cm recorded.
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At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
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Health Related Fitness Outcome - Balance
Ramy czasowe: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
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Balance will be assessed using a static balance test.
The test requires the participant to balance on one foot and then the other as long as they can (length of time to a maximum of 45 seconds) while standing on a 2.54 by 2.54 by 30.5 cm base using a standardized protocol, reported by Fleishman.
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At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Lauren C Capozzi, PhD Student, University of Calgary
- Główny śledczy: Harold Lau, MD, Tom Baker Cancer Centre, University of Calgary
- Główny śledczy: Raylene Reimer, PhD, University of Calgary
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2012
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2014
Ukończenie studiów (Rzeczywisty)
1 grudnia 2014
Daty rejestracji na studia
Pierwszy przesłany
31 sierpnia 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 września 2012
Pierwszy wysłany (Oszacować)
10 września 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
26 października 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 października 2016
Ostatnia weryfikacja
1 października 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ENHANCE10001991
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .