Notice2021-23456
Supplemental Evidence and Data Request on Nutrition as Prevention for Improved Cancer Outcomes
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 28, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Nutrition as Prevention for Improved Cancer Outcomes, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 86 Issue 206 (Thursday, October 28, 2021)</title>
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[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59718-59720]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23456]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Nutrition as Prevention
for Improved Cancer Outcomes
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Nutrition as
Prevention for Improved Cancer Outcomes, which is currently being
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program.
Access to published and unpublished pertinent scientific information
will improve the quality of this review.
DATES: Submission Deadline on or before November 29, 2021.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#3451445774555c46451a5c5c471a535b42"><span class="__cf_email__" data-cfemail="294c594a6948415b580741415a074e465f">[email protected]</span></a>
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: <a href="/cdn-cgi/l/email-protection#7c190c1f3c1d140e0d5214140f521b130a"><span class="__cf_email__" data-cfemail="a8cdd8cbe8c9c0dad986c0c0db86cfc7de">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Nutrition as
Prevention for Improved Cancer Outcomes. AHRQ is conducting this
technical brief pursuant to Section 902 of the Public Health Service
Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Nutrition as Prevention for Improved Cancer Outcomes,
including those that describe adverse events. The entire research
protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/improved-cancer-outcomes/protocol">https://effectivehealthcare.ahrq.gov/products/improved-cancer-outcomes/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Nutrition as Prevention for Improved Cancer
Outcomes helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ 1: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions prior to cancer treatment in preventing negative
treatment outcomes such as effects on dose tolerance, hospital
utilizations, adverse events and survival?
a. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary by cancer type,
treatment type (chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. KQ1c: Compared to adults without muscle wasting, do nutritional
interventions prevent the negative outcomes associated with cancer
[[Page 59719]]
treatment in adults with muscle wasting?
d. KQ1d: Do the effects of nutritional interventions on preventing
the negative outcomes associated with cancer treatment vary across
special populations (e.g., individuals with multiple comorbid
conditions)?
KQ 2: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions during cancer treatment in preventing negative treatment
outcomes such as effects on dose tolerance, hospital utilizations,
adverse events and survival?
a. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary by cancer type,
treatment type (chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. Compared to adults without muscle wasting, do nutritional
interventions prevent the negative outcomes associated with cancer
treatment in adults with muscle wasting?
d. Do the effects of nutritional interventions on preventing the
negative outcomes associated with cancer treatment vary across special
populations (e.g., individuals with multiple comorbid conditions)?
KQ 3: In adults diagnosed with cancer who have or are at risk for
cancer-associated malnutrition, what is the effect of nutritional
interventions prior to or during cancer treatment on associated
symptoms such as fatigue, nausea and vomiting, appetite, physical and
functional status (e.g., frailty), and quality of life?
a. Do the effects of nutritional interventions on symptoms
associated with cancer treatment vary by cancer type, treatment type
(chemotherapy, radiation, surgery) and stage of disease?
b. Do the effects of nutritional interventions vary across the
lifespan (e.g., adults aged >=65 years vs. <65 years)?
c. Compared to adults without muscle wasting, do nutritional
interventions differentially effect symptoms associated with cancer
treatment in adults with muscle wasting?
d. Do the effects of nutritional interventions on symptoms
associated with cancer treatment vary across special populations (e.g.,
individuals with multiple comorbid conditions)?
KQ 4: In adults with cancer who are overweight or obese, what is
the effect of nutritional interventions intended for weight loss prior
to or during cancer treatment in preventing negative treatment outcomes
such as effects on dose, hospital utilizations, adverse events and
survival?
Contextual Question (CQ)
CQ 1: What evidence is available on the cost-effectiveness of
nutritional interventions for preventing negative outcomes associated
with cancer treatment?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
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KQ3: pre- or during
KQ1: pre-treatment KQ2: nutritional treatment nutritional KQ4: weight loss in
PICOTS nutritional interventions interventions (NIs) and overweight/obese adults
interventions during treatment patient-centered with cancer
(PNIs) (NIDTs) outcomes
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Population............ Adults diagnosed with cancer at or after age 18 who have or are Overweight (BMI 25-<30)/
at risk for cancer-associated malnutrition. obese (BMI >=30)
Subgroups: adults >=18y of age
<bullet> Cancer and treatment characteristics (cancer type, diagnosed with cancer.
treatment type (systemic therapy, radiation, surgery), stage
of disease).
<bullet> Adults >=65y vs younger.
<bullet> Muscle wasting (e.g., sarcopenia, cachexia, pre-
cachexia) vs. no muscle wasting.
<bullet> Special populations (individuals with multiple co-
morbid conditions).
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Interventions......... Nutritional interventions under the supervision of a nutrition Nutritional
professional (e.g., dietician, nutritionist, or other licensed Interventions intended
clinicians). for weight loss
(includes both PNIs
and NIDTs).
<bullet> Diet or nutrition therapy (via oral or enteral (e.g.,
nasogastric, gastrostomy, jejunostomy) feeding.
[cir] Special diets (e.g., fasting (intermittent or short-
term), calorie restriction, ketogenic, Mediterranean diet,
high calorie, high protein).
[cir] Supplements.
<bullet> Total parenteral therapy.
<bullet> Nutritional counseling.
<bullet> Combined nutritional interventions (e.g., nutritional
counseling with nutrition therapy).
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Comparators........... Standard of care Standard of care Standard of care vs Standard of care vs
vs PNIs or PNIs vs NIDTs, NIDT vs PNIs or NIDTs, NIDTs PNIs or NIDTs, NIDTs
vs PNIs. NIDT or PNIs vs. vs. NIDTs, PNIs vs. vs. NIDTs, PNIs vs.
NIDTs. PNIs, PNIs vs NIDTs. PNIs, PNIs vs NIDTs.
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Outcomes.............. Intermediate Outcomes Intermediate Outcomes.
BMI, Body composition, Weight (loss, Fatigue, nausea and BMI, Body composition,
gain). vomiting, appetite, Weight (loss, gain).
physical/functional
status (e.g., frailty).
Final Outcomes. Final Outcomes.
Cancer treatment tolerance: treatment Quality of life........ Cancer treatment
interruptions, reductions, or delays. tolerance: treatment
interruptions,
reductions, or delays.
Hospital utilizations: ER visits, Hospital utilizations:
Admissions, Length of stay. ER visits.
Admissions, Length of
stay.
Adverse events. Adverse events.
<bullet> Chemotherapy/radiation <bullet> Chemotherapy/
therapy limiting toxicity. radiation therapy
limiting toxicity.
<bullet> Post-op complication. <bullet> Post-op
complication.
<bullet> NI-related AEs. <bullet> NI-related
AEs.
<bullet> Unintended harms. <bullet> Unintended
harms.
Survival. Survival.
Nutritional status. Nutritional Status.
Malnutrition (underweight, wasting, Malnutrition
overweight). (underweight, wasting,
overweight).
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[[Page 59720]]
Timing................ Nutritional interventions delivered pre- cancer treatment (KQ1, KQ3, KQ4) and during
cancer treatment (KQ2, KQ3, KQ4).
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Setting............... Outpatient Oncology Care, Ambulatory Care, Cancer Treatment Centers, inpatient, home-
based, hospice, telemedicine.
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Abbreviations: KQ = key question; BMI = body mass index; ER = emergency room; PICOTS = population, intervention,
comparator, outcomes, timing, setting; RCT = randomized controlled trial; NRCT = non-randomized controlled
trial.
Dated: October 22, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-23456 Filed 10-27-21; 8:45 am]
BILLING CODE 4160-90-P
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