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Intervention to Motivate Standing &Walking in Gastrointestinal Cancer Surgical Patients

2019年2月21日 更新者:Niraj J. Gusani MD、Milton S. Hershey Medical Center
Observational research has linked physical activity with faster recovery, improved quality of life, and greater survival; however, little is known about the effects of physical activity in pre-operative, peri-operative, or post-operative treatment contexts and there is a need for interventions to improve patient outcomes across the cancer treatment continuum. Three propositions derived from basic research, epidemiological evidence, and clinical practice informed our intervention development efforts: (1) Patient outcomes will be enhanced by interventions that increase physical activity (i.e., standing, walking) across the cancer treatment continuum (i.e., pre-operative, peri-operative, post-operative). (2) Reducing sedentary behavior (i.e., seated or reclined activities involving minimal energy expenditure) will enhance patient outcomes both by increasing physical activity and by stimulating additional adaptive physiological responses to reduced sedentary time (responses which are independent of physical activity-induced responses). (3) Patients with gastrointestinal cancers often suffer functional limitations that limit their independence and their health behaviors are strongly influenced by the family environment so interventions that engage caregivers (e.g., spouses) will be more effective than those that target patients/survivors alone.

調査の概要

状態

完了

詳細な説明

Phase 1 Screening and Baseline Assessment in Clinic Patients will be recruited by their physician upon diagnosis and immediately after the Penn State Surgical Oncology team presents then with the surgical treatment option. The patient must be able to identify an adult caregiver. The caregiver must be someone who is willing to participate in the study for the intervention period.

Once enrolled by the research assistant, the participant will complete an intake questionnaire to capture demographic information. The participant will then be given a tablet computer, training on how to use it to complete the questionnaires at the beginning and end of each day, an activity monitor with materials for securing it, and training on how/where to affix it on the leg.

In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase). Although intentions are necessary for behavior change, a recent review of experimental evidence indicates that they are not sufficient. In the volitional phase, people translate those intentions into action by developing actions plans that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk around my neighborhood) and coping plans that specify how they will overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have already developed an electronic daily planning tool that can be used at the beginning of each day to form action and coping plans for the target behaviors in this intervention. In the first two months of this project, we will tailor this existing planning tool for the target population by drawing from existing and emerging research on strategies for and barriers to health behaviors among cancer patients.

The control group will not receive the educational or daily planning components of the motivational intervention. They will, however, engage in self-monitoring by virtue of wearing activity monitors and using tablet computers to provide self-report data on their physical activity and sedentary behavior.

After the patient's surgery while staying at the Penn State Hershey Medical Center, the study coordinator will provide the caregiver with behavioral goals to help the patient recover from his/her surgery, and additional information about how the caregiver can support the patient's behavior change efforts.

Phase 2: Intervention Period

For the duration of the study, participant will:

  • Complete beginning-and end -of-day questionnaires on the tablet computer. The beginning of day questionnaire will evaluate the patient's intentions and plans for daily physical activity. The end of day questionnaire will evaluate actual physical activity completed daily as well as the patient's physical, emotional, and social well-being.
  • Wear and activity monitor

For participants in the experimental group the research assistant will also:

  • Deliver the educational intervention for patients and caregivers during their first visit after they have signed the consent forms.
  • Train patients how to use the daily planning tool prior to the beginning -of- day prior to the beginning-of-day questionnaires.

The theoretical basis for our intervention draws from both social-cognitive theory (i.e., Health Action Process Approach [HAPA]) and self-determination theory. The Health Action Process Approach differentiates between motivational and volitional phases of action control. In the motivational phase, people form intentions or goals for their behavior based on factors such as risk awareness and outcome expectations. In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase). Although intentions are necessary for behavior change, a recent review of experimental evidence indicates that they are not sufficient. In the volitional phase, people translate those intentions into action by developing actions plans that specify when/where/how they will act (e.g., after lunch I will go on a 30 min walk around my neighborhood) and coping plans that specify how they will overcome anticipated barriers to desired behavior (e.g., if it rains after lunch, I will go to the mall to walk for 30 min). Repeated planning of this nature is the basis for breaking existing behavioral habits and forming newer (and hopefully more adaptive) ones. We have already developed an electronic daily planning tool that can be used at the beginning of each day to form action and coping plans for the target behaviors in this intervention. In the first two months of this project, we will tailor this existing planning tool for the target population by drawing from existing and emerging research on strategies for and barriers to health behaviors among cancer patients.

Self-determination theory posits that social factors, such as family relationships, can also influence motivation. Our recent work using experience sampling methodology and accelerometry has shown that spouses' autonomy support for patient physical activity and the spouse's level of physical activity were associated with patients' greater daily moderate physical activity and steps taken Individuals whose family members or health care providers show autonomy support for increasing physical activity and decreasing sedentary behavior are more likely to make those changes for reasons that come from within themselves and are freely chosen. Because close family members influence the emotional and physical well-being of patients, their inclusion in behavioral interventions is logical and has the potential to boost the effects of those interventions. In this study, caregivers will be educated about the importance of autonomy support in behavior change and strategies for supporting their partner's autonomy around physical activity and sedentary behavior change across the stages of treatment. This education will be delivered by the nurse coordinator at the initial education session following enrollment.

Collectively, these three components of patient education, daily planning, and caregiver education were assembled to strengthen intentions for desired health behaviors (motivational phase of behavior change), to increase the likelihood that such intentions will translate into action (volitional phase of behavior change), and to provide social resources that support behavior change in both of those phases.

The control group will not receive the educational or daily planning components of the motivational intervention. They will, however, engage in self-monitoring by virtue of wearing activity monitors and using tablet computers to provide self-report data on their physical activity and sedentary behavior.

During the intervention period the study coordinator will also contact the patient via phone weekly to ask questions related to the patients safety including questions about frequency of falls mild/moderate/severe, chest pain, dizziness, musculoskeletal soreness or pain, and changes in swelling.

Phase 3: Follow-Up Telephone Call

The research assistant will call the participant 30, 60, and 90 days after surgery to assess the frequency of hospital readmission or emergency room visits since being discharged.

Phase 4: Follow- Up Questionnaire

21 days after discharge form the hospital, participants and caregivers will complete a brief questionnaire that we will mail to them with a self-addressed stamped envelope.

研究の種類

介入

入学 (実際)

32

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。

研究場所

    • Pennsylvania
      • Hershey、Pennsylvania、アメリカ、17033
        • Penn State Hershey Medical Center

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of gastrointestinal tract cancer (hepatobiliary) requiring surgical resection. for treatment
  • Failing to meet the aerobic component of national physical activity guidelines over past week (e.g., < 150 min moderate-intensity physical activity or < 75 min vigorous-intensity physical activity).
  • Excessive sedentary behavior over the past week (> 8 hrs/day sitting).
  • Minimum age 18 years.
  • A spouse or adult child serving as a caregiver who is also willing to participate.

Exclusion Criteria:

  • Functional limitations that preclude normal physical activity.
  • Patients who will be scheduled for surgery < 10 days after their clinic visit.
  • Medical contraindications to physical activity.

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:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Education/Daily Planning
Physical Activity Education and Daily Planning Tool
In this study, we will use educational materials delivered at the initial enrollment session and in daily "facts of the day" presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase)
介入なし:No Education/Daily Planning
No Physical Activity Education/ Daily Planning Tool

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
Percentage of patients with diagnosed gastrointestinal cancer who showed daily compliance using activity monitors and tablet computers to measure physical activity.
時間枠:up to 1 year
To demonstrate the feasibility and acceptability of using activity monitors and tablet computers to measure physical activity (standing, walking)/sedentary behavior (sitting) and deliver daily interventions in this patient population, we will evaluate daily compliance using activity monitors and tablet computers.
up to 1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of patients with a diagnosis of gastrointestinal cancer that benefit from an intervention of physical activity daily planning and education.
時間枠:up to 1 year
To evaluate the efficacy of this intervention, we will conduct a pilot study of a two-arm randomized controlled trial of the intervention against a self-monitoring control group.
up to 1 year

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:Niraj J Gusani, M.D., M.S.、Milton S. Hershey Medical Center
  • スタディディレクター:David E Conroy, Ph.D、Penn State University

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。

一般刊行物

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

2013年10月1日

一次修了 (実際)

2015年7月1日

研究の完了 (実際)

2018年12月1日

試験登録日

最初に提出

2013年10月28日

QC基準を満たした最初の提出物

2013年11月6日

最初の投稿 (見積もり)

2013年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月22日

QC基準を満たした最後の更新が送信されました

2019年2月21日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 41440

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。

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