The STRONG Nutrition Support Study for People With Pancreatic Cancer (STRONG)
2026年9月14日 更新者：UNC Lineberger Comprehensive Cancer Center
This single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation therapy.
Approximately 80 participants will be randomized 1:1 to receive nutrition counseling plus either the STRONG app or printed nutrition education materials.
Outcomes include feasibility, acceptability, nutritional status, quality of life, healthcare utilization, treatment delivery, caregiver outcomes, and survival.
Findings will inform the design of a future trial evaluating whether app-based, tailored nutrition support improves outcomes compared with traditional nutrition education.
調査の概要
研究の種類
介入
入学 (推定)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emma C Hume
- 電話番号：9199664260
- メール：Emma.Hume@unc.edu
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
-
主任研究者：
- Kea Turner, PhD, MPH, MA
-
コンタクト：
- Emma C Hume
- 電話番号：919-966-4260
- メール：Emma.Hume@unc.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Patients Participants
Inclusion Criteria:
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Diagnosis of pancreatic ductal adenocarcinoma
- Has initiated or scheduled to initiate systemic therapy and/or radiation therapy within 30 days of study enrollment
- Able to speak and read English
Exclusion Criteria:
- Enrolled in hospice care or has a plan for hospice enrollment at the time of study enrollment
- Not community dwelling at the time of study enrollment, including individuals who are incarcerated, residing in a skilled nursing facility, long-term care facility, or other institutional setting where meals, nutrition management, or access to study procedures are primarily controlled by the institution
- Unable to consume food or beverages orally at the time of consent, including individuals who are fully dependent on total parenteral nutrition or who have complete malignant bowel obstruction or severe gastric outlet obstruction that prevents meaningful oral intake or makes oral nutrition unsafe.
- Any condition or circumstance that, in the judgment of the investigator or designee, such as a patient's oncologist, would make study participation inappropriate or would interfere with the participant's ability to complete study procedures, such as advanced dementia or other severe cognitive impairment.
Caregiver Participants
Inclusion Criteria:
- Age ≥18 years at the time of consent.
- Identified by an enrolled patient participant as their primary caregiver or support person.
- Able to speak and read English
- Able to provide informed consent.
- Willing and able to complete caregiver study procedures, including baseline and follow-up questionnaires and, if selected and interested, an optional exit interview.
Exclusion Criteria:
• Any condition or circumstance that, in the judgment of the investigator or designee, would make participation inappropriate or would interfere with completion of study procedures, such as advanced dementia or other severe cognitive impairment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1: Remote Dietitian-Led Nutrition Counseling Plus STRONG
Participants randomized to the STRONG arm will receive individualized nutrition counseling delivered remotely by a registered dietitian, in addition to access to the STRONG intervention.
The intervention will be delivered over approximately 3 months and will include one initial remote dietitian visit and two remote follow-up visits.
Participants will use the STRONG app to support nutrition-related education, self-management, and engagement between counseling visits.
|
STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
|
|
アクティブコンパレータ：Arm 2: Remote Dietitian-Led Nutrition Counseling Plus Printed Nutrition Education Materials
Participants randomized to the comparison arm will receive the same schedule of individualized remote dietitian-led nutrition counseling as participants in the STRONG arm, consisting of one initial visit and two remote follow-up visits over approximately 3 months.
In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.
|
individualized remote dietitian visits consisting of one initial visit and two remote follow-up visits over approximately 3 months.
In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：Baseline
|
Proportion of eligible patient participants who provide informed consent and enroll in the study.
The feasibility benchmark is ≥50%.
Recruitment Rate (%) = (Number of eligible patients who consent and enroll ÷ Number of eligible patients approached) × 100
|
Baseline
|
|
Retention Rate
時間枠：Baseline
|
Proportion of enrolled patient participants who remain in the study through completion of the 3-month intervention period.
The feasibility benchmark is ≥85%.
Retention Rate (%) = (Number of enrolled participants who complete the 3-month intervention period ÷ Total number of enrolled participants) × 100
|
Baseline
|
|
Study Assessment Completion
時間枠：Up to 6 months
|
The proportion of enrolled participants who complete at least 2 of the 3 scheduled study assessments during the study period.
Assessment Completion Rate (%) = (Number of enrolled participants who complete ≥2 of 3 assessments ÷ Total number of enrolled participants) × 100
|
Up to 6 months
|
|
Remote Nutrition Counseling Completion
時間枠：Up to 6 months
|
Proportion of randomized patient participants who complete at least 2 of the 3 planned remote dietitian counseling visits during the 3-month intervention period.
The feasibility benchmark is ≥70%.
Counseling Completion Rate (%) = (Number of randomized participants who complete ≥2 of 3 counseling visits ÷ Total number of randomized participants) × 100
|
Up to 6 months
|
|
STRONG Engagement
時間枠：Up to 6 months
|
The proportion of STRONG-arm participants who demonstrate sustained engagement with the STRONG intervention by accessing STRONG at least once per week during at least 6 of the 12 intervention weeks.
STRONG Engagement Rate (%) = (Number of STRONG-arm participants who access STRONG ≥1 time/week during ≥6 of 12 intervention weeks ÷ Total number of STRONG-arm participants) × 100
|
Up to 6 months
|
|
Food and Symptom Diary Completion
時間枠：Up to 6 months
|
Among STRONG-arm patient participants, the proportion who complete the food and symptom diary on at least 2 of the 3 days preceding each of the three planned dietitian counseling visits. The feasibility benchmark is ≥70%. Diary Completion Rate (%) = (Number of STRONG-arm participants who complete the diary on ≥2 of 3 days before all 3 counseling visits ÷ Total number of STRONG-arm participants) × 100 |
Up to 6 months
|
|
Intervention Fidelity
時間枠：Up to 6 months
|
Proportion of completed dietitian counseling visits in which all required counseling elements outlined in the study counseling checklist were documented as delivered. The fidelity benchmark is ≥80%. Intervention Fidelity (%) = (Number of completed counseling visits with documentation that all required checklist elements were delivered ÷ Total number of completed counseling visits) × 100 |
Up to 6 months
|
|
Reasons for Non-Participation or Attrition
時間枠：Up to 6 months
|
Reasons for declining participation, inability to enroll, withdrawal, missed counseling visits, incomplete diary use, or incomplete study assessments will be documented and summarized descriptively when available.
|
Up to 6 months
|
|
Overall Satisfaction with STRONG
時間枠：Up to 6 months
|
Proportion of STRONG-arm patient participants who complete the 3-month survey and report satisfaction with STRONG.
The acceptability benchmark is ≥80%.
Satisfaction Rate (%) = (Number of STRONG-arm participants who complete the 3-month survey and report satisfaction with STRONG ÷ Number of STRONG-arm participants who complete the 3-month survey) × 100
|
Up to 6 months
|
|
Satisfaction with Intervention Components
時間枠：Up to 6 months
|
Among STRONG-arm patient participants, the proportion who report satisfaction with each of the three intervention components: remote nutrition counseling, STRONG, and the food and symptom diary. Component Satisfaction Rate (%) = (Number of STRONG-arm participants who report satisfaction with the component ÷ Number of STRONG-arm participants who complete the relevant satisfaction item) × 100 |
Up to 6 months
|
|
Perceived Benefit
時間枠：Up to 6 months
|
Proportion of STRONG-arm patient participants who report that STRONG was beneficial or helpful for managing nutrition concerns during pancreatic cancer treatment. Perceived Benefit Rate (%) = (Number of STRONG-arm participants who report that STRONG was beneficial or helpful ÷ Number of STRONG-arm participants who complete the relevant survey item) × 100 |
Up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Nutritional Status
時間枠：Baseline and up to 6 months
|
The Patient-Generated Subjective Global Assessment (PG-SGA) Short Form is a nutrition screening tool that assesses recent weight change, food intake, nutrition-impact symptoms, and functional status.
Scores range from 0 to 36, with higher scores indicating greater nutritional risk and need for intervention: 0-1 suggests no immediate intervention, 2-3 indicates possible need for patient education or symptom management, 4-8 indicates a need for intervention by a dietitian or nutrition professional, and ≥9 indicates a critical need for nutrition intervention and/or symptom management.
|
Baseline and up to 6 months
|
|
Changes in General Health-related Quality of Life
時間枠：Baseline and up to 6 months
|
General health-related quality of life was assessed using Change in Functional Assessment of Cancer Therapy-General (FACT-G) score. The Functional Assessment of Cancer Therapy-General (FACT-G) is a validated 27-item questionnaire used to assess health-related quality of life (HRQoL) in people with cancer. It evaluates four domains: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), and Functional Well-Being (0-28), giving a total score ranging from 0 to 108. Each item is rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Very much"). Higher FACT-G scores indicate better quality of life, while lower scores indicate greater impairment or burden. |
Baseline and up to 6 months
|
|
Appetite/Cachexia-Related Quality of Life
時間枠：Baseline, up to 6 months
|
Change in Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscale score from baseline to 3 months and from baseline to 6 months.
The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) is a patient-reported measure designed to assess quality of life and symptoms associated with cancer-related anorexia/cachexia.
It combines the FACT-G questionnaire with an additional 12-item Anorexia/Cachexia Subscale (A/CS), for a total of 39 items.
Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored.
The FAACT total score ranges from 0-156, and higher scores generally indicate better quality of life and fewer anorexia/cachexia-related concerns.
Changes in FAACT scores over time can therefore be used to evaluate whether a patient's symptoms and overall quality of life have improved or worsened.
|
Baseline, up to 6 months
|
|
Hepatobiliary/Pancreatic Cancer-Related Quality of Life
時間枠：Baseline, up to 6 months
|
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score from baseline to 3 months and from baseline to 6 months.
The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is a 44-item patient-reported questionnaire assessing health-related quality of life in patients with hepatobiliary cancer.
It combines the 27-item FACT-G with a 17-item Hepatobiliary Cancer Subscale (HCS).
Each item is scored from 0 ("Not at all") to 4 ("Very much"), with negatively worded items reverse-scored.
The total FACT-Hep score ranges from 0 to 176, with higher scores indicating better quality of life and lower scores indicating greater symptom burden or impairment.
|
Baseline, up to 6 months
|
|
Healthcare Utilization
時間枠：Up to 6 months
|
Healthcare Utilization: Number of emergency department visits during the study period, assessed by participant self-report and/or medical record abstraction, when available.
|
Up to 6 months
|
|
Treatment Delivery
時間枠：Up to 6 months
|
Treatment Delivery will be defined based on records related to treatment delay, dose reduction, and treatment discontinuation during the study period, assessed by medical record abstraction.
|
Up to 6 months
|
|
Survival Outcomes
時間枠：Up to 6 months
|
Overall survival and progression-free survival, assessed using cancer registry data and/or medical record abstraction.
|
Up to 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
時間枠：Up to 6 months
|
Caregiver burden will be assessed using the 12-item Short Form of the Zarit Burden Interview.
The outcome will be the change in ZBI score from baseline to 3 months and from baseline to 6 months.
The Zarit Burden Interview (ZBI) 12-item Short Form is a self-report measure of caregiver burden.
It assesses how caregiving affects the caregiver's emotional, social, physical, and financial well-being.
The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
|
Up to 6 months
|
|
Change in caregiver quality of life
時間枠：Baseline, up to 6 months
|
Caregiver quality of life will be assessed using the Caregiver Quality of Life Index-Cancer (CQOLC), a self-report instrument designed to assess the quality of life of individuals providing care to patients with cancer.
The CQOLC evaluates multiple domains of caregiver quality of life, including emotional distress, burden, positive adaptation, and disruption of daily activities.
The total score ranges from 0-140, with higher scores indicating better caregiver quality of life[M.
|
Baseline, up to 6 months
|
|
Change in caregiver distress
時間枠：Baseline, up to 6 months
|
Caregiver distress will be assessed using the caregiver-specific version of the National Comprehensive Cancer Network (NCCN) Distress Thermometer.
The Distress Thermometer is a self-report measure of overall distress rated on a 0-to-10 scale, with 0 indicating no distress and 10 indicating extreme distress.
The caregiver-specific version includes additional problem areas relevant to caregiving, such as assisting with symptom management and providing emotional support.
Higher scores indicates greater distress.
|
Baseline, up to 6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Kea Turner, PhD, MPH, MA、UNC Lineberger Comprehensive Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2029年8月1日
研究の完了 (推定)
2029年8月1日
試験登録日
最初に提出
2026年9月8日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STRONG
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Researchers may request de-identified data 1 year after publication.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。