- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00405782
Exercise Intervention in Women With Metastatic Breast Cancer
24. juni 2016 opdateret af: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Pilot Study of a Moderate-Intensity Exercise Intervention in Women With Metastatic Breast Cancer
This study is being done to evaluate the impact of moderate-intensity exercise (such as walking) on quality of life, energy level, endurance and mood in women with metastatic breast cancer.
Studies have shown that women with early stage breast cancer who exercise during treatment have more energy, less sleep disturbance, less anxiety and depression, and better strength and endurance than women who do not exercise.
These studies have also shown that women who exercised during treatment for early stage breast cancer did not develop injuries or increased fatigue from exercising during chemotherapy and radiation treatments.
The investigators are conducting this trial to see if women with metastatic breast cancer experience similar benefits from exercise as women with earlier breast cancer.
The investigators also wish to determine whether women with advanced disease are able to exercise safely during their treatment under the supervision of an exercise physiologist.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- Participants will be randomized to one of two groups. Study participants assigned to Group A will immediately participate in a 16-week exercise program, and participants assigned to Group B will wait 16 weeks before taking part in an exercise program.
- Before beginning the exercise program (Group A) or waiting period (Group B), participants will undergo a series of tests to measure exercise capacity, fatigue level and quality of life. They will be asked to complete a series of questionnaires and meet with an exercise physiologist and undergo a treadmill test designed to measure physical fitness in patients with a chronic illness. The participant will complete the questionnaires again 8 weeks after enrolling in the protocol and will complete one final set and undergo a second treadmill test after the 16-week study period has ended.
- Participants in Group A will be given a 16-week gym membership, as well as a heart rate monitor and a pedometer. They will meet with an exercise physiologist, who will design an exercise program for each participant. Participants will meet with the exercise physiologist weekly for 4 weeks, then once per month for the duration of the study. The target exercise goal will be 150 minutes of moderate-intensity exercise each week.
- Participants will be given an exercise journal to record the minutes of cardiovascular exercise and steps taken each day. These journals will be reviewed by the exercise physiologist each week.
- Participants in Group B will be allowed to exercise as much as they wish during the first 16-weeks of their time on the study, but they will not be given a formal exercise plan or a gym membership until the completion of the 16-week waiting period. During this time, they will also complete questionnaires at the time of study entry, 8 weeks after enrolling, and at the end of 16 weeks. After the 16-week delay period has passed, participants in Group B will be given a pedometer, heart rate monitor and 16-week gym membership. They will also meet with an exercise physiologist weekly for one month, and the exercise physiologist will design an individualized exercise plan for these participants.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
101
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02115
- Beth Isreal Deaconess Medical Center
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Metastatic or locally advanced breast cancer not amenable to curative surgery
- Life expectance of greater than 12 months
- English speaking
- Pre- and postmenopausal
- Performance status 0-1
Exclusion Criteria:
- Baseline exercise of more than 150 minutes/week
- Active brain metastases
- Uncontrolled cardiac disease
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Immediate Exercise Group
Exercise Intervention begins immediately
|
Exercise program designed by exercise physiologist
|
Aktiv komparator: Delayed Exercise Group
Exercise intervention delayed by 16 weeks
|
Exercise program designed by exercise physiologist
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the impact of a 16 week exercise intervention on physical functioning and cardiorespiratory fitness in a group of patients with metastatic breast cancer.
Tidsramme: 16 weeks
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the impact of a 16-week exercise intervention on quality of life, fatigue and mood in a group of patients with metastatic breast cancer
Tidsramme: 16 weeks
|
16 weeks
|
To test the feasibility of an exploratory measure of health care utilization in a population of patients with metastatic breast cancer and potential impact on a 16-week exercise intervention on health care utilization.
Tidsramme: 16 weeks
|
16 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
1. august 2006
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. april 2016
Datoer for studieregistrering
Først indsendt
28. november 2006
Først indsendt, der opfyldte QC-kriterier
28. november 2006
Først opslået (Skøn)
30. november 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2016
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-212
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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