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Exercise Intervention for Cancer Survivors

26. januar 2017 opdateret af: Duke University

Exercise Outcome Expectations Among Breast Cancer Survivors

This randomized controlled trial will test a multicomponent intervention to increase exercise Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels of exercise. Sixty early stage breast cancer survivors will be recruited from the Duke Cancer Institute. Participants will be randomized to the exercise OE intervention or an attention control group. Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer. The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of). The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.

Studieoversigt

Detaljeret beskrivelse

This study will test a theory-based intervention to increase levels of exercise among breast cancer survivors, in order to help them self-manage their long-term treatment side effects. The study focuses on outcome expectations (OEs), a significant yet understudied construct that is central to most behavior change theories. OEs refer to what people expect to obtain or avoid by engaging in a behavior; thus, people exercise because they believe it will produce desired outcomes. This randomized controlled trial will test a multicomponent intervention to increase exercise OEs and assess effects of OE changes on exercise intentions and levels of exercise. Sixty early stage (IA to IIB) inactive breast cancer survivors will be recruited from the Duke Cancer Institute. Participants will be randomized to the exercise OE intervention or an attention control group. Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer. The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of). The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise. OE importance, OE certainty, OE accessibility, exercise intentions, exercise, and self-efficacy (a potential co-variate) will be assessed through online surveys at baseline, 4-, 8-, and 12-weeks post-intervention. At each time point, accelerometer data will be collected as an objective exercise measure. Specific aims of the study are to: (1) examine trajectories of OE importance, certainty and accessibility between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4-, 8- and 12-weeks post-intervention; and (2) examine trajectories of exercise intentions and total weekly minutes of exercise, between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4, 8 and 12 weeks post-intervention. If the intervention increases exercise among breast cancer survivors it may lead to improved survivorship duration and quality of life. The intervention can be implemented readily in clinic settings to support survivors to exercise more and thus experience better long-term outcomes. This study also provides a foundation for a developing a nurse scientist's program of research focused on designing theory-based exercise interventions for chronically ill populations.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University School of Nursing

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. stage 1A - 2B breast cancer diagnosis;
  2. 2 months - 10 years status post surgery, radiation and chemotherapy;
  3. inactive (self-reported ≤ 150 min/wk moderate - strenuous-intensity exercise);
  4. no evidence of cancer recurrence;
  5. no pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program (e.g., severe orthopedic conditions, scheduled hip or knee replacement within 6 months, paralysis and/or dementia, unstable angina, history of myocardial infarction, congestive heart failure);
  6. English-speaking and writing;
  7. access and ability to use a computer for completion of online measures; and
  8. possession of smartphone

Exclusion Criteria:

None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: exercise outcome expectation workbook
Intervention arm participants will receive: 1) the ACS exercise and diet guidelines; and 2) an exercise outcome expectation workbook. The workbook contains self-directed activities to increase OE importance, certainty, and accessibility. The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many positive exercise outcomes breast cancer survivors may experience. Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist. Accessibility will be increased by having the participant think about the association between exercise and its outcomes.
The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many and diverse positive outcomes breast cancer survivors may experience. Participants will then be asked to focus on the three OEs they would most like to experience. Each section of the OE guide contains activities to target specific OE dimensions. Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist. Accessibility will be increased by having the participant think about the association between exercise and its outcomes
Aktiv komparator: diet workbook
Attention control participants will receive via mail 1) the ACS exercise and diet guidelines; and 2) a diet workbook. The diet workbook contains the same activities as the exercise outcome expectation workbook but is focused on diet instead of exercise.
The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
change in OE importance, as measured by questionnaire
Tidsramme: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in OE accessibility, as measured by questionnaire
Tidsramme: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in OE certainty, as measured by questionnaire
Tidsramme: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention

Sekundære resultatmål

Resultatmål
Tidsramme
change in intentions to exercise, as measured by questionnaire
Tidsramme: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention
change in total weekly minutes of exercise
Tidsramme: baseline 4- 8- and 12-weeks post intervention
baseline 4- 8- and 12-weeks post intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

23. januar 2015

Først indsendt, der opfyldte QC-kriterier

23. januar 2015

Først opslået (Skøn)

28. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2017

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro00059469

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neoplasmer

Kliniske forsøg med Exercise OE workbook

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