- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00801008
Exercise and Relaxation Intervention for Young Adult Cancer Survivors
19. april 2012 opdateret af: Carolyn Rabin, The Miriam Hospital
The purpose of this study is to develop an exercise and relaxation program for young adults (age 18 to 39) who have completed their treatment for cancer.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
There is evidence that cancer diagnosis and treatment during young adulthood puts survivors at risk for a number of medical and psychosocial difficulties including cardiovascular disease, second cancers and psychological distress.
The proposed research is aimed at developing a physical activity and relaxation intervention for young adult cancer survivors in order to address some of their medical and psychosocial risks.
The objective of the study is to pilot test a 12-week physical activity and relaxation intervention in this population.
We hypothesize that the intervention will be feasible for and acceptable to young adult cancer survivors.
We also hypothesize that the intervention group will demonstrate increased levels of physical activity, improved mood and reduced fatigue relative to the wait list control group at the 12-week and 24-week follow-up assessments; statistically significant differences may not be found due to the small sample size, however.
In addition, we will conduct exploratory tests of intervention effects on fitness, flexibility, body mass, and waist circumference.
Sixty participants will be recruited for the pilot study.
Participants will be randomly assigned to receive a 12-week physical activity and relaxation intervention or to a wait list control group.
Intervention group participants will receive 12 weeks of behavior change counseling, based on the Transtheoretical Model and Social Cognitive Theory, to help them adopt a program of brisk walking and learn mindfulness meditation.
They will also be given access to an online discussion group.
Participants in both arms of the study will be assessed at baseline, 12 weeks, and 24 weeks.
Following the 24-week assessment, wait list control participants will offered the 12-week intervention and one additional assessment (i.e., at 36 weeks).
Data will be collected on intervention feasibility (e.g., number of counseling sessions delivered) and acceptability (e.g., general satisfaction ratings).
ANCOVAs will be used to conduct preliminary tests of intervention effects (e.g., on physical activity, mood, and fatigue).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rekruttering
- Miriam Hospital
-
Kontakt:
- Carolyn Rabin, PhD
- Telefonnummer: 401-793-8234
- E-mail: CRabin@lifespan.org
-
Ledende efterforsker:
- Carolyn Rabin, PhD
-
-
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
18 år til 39 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age 18 to 39
- diagnosed with any form of cancer (except non-melanoma skin cancer)
- diagnosed between age 18 and 39 in the past 10 years
- completed all surgery, chemotherapy and radiation therapy
- currently in a cancer remission
- able to speak and write English fluently
- sedentary (i.e., not regularly physically active)
- not currently engaging in a relaxation strategy
- score above a cutoff on a fatigue screener
Exclusion Criteria:
- the intention to get pregnant
- the presence of a known medical condition or history of severe psychiatric illness that would make participation dangerous or very difficult
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 |
|---|---|
|
Eksperimentel: Exercise and Relaxation Intervention
Participants in this arm will receive a 12 week exercise and relaxation intervention
|
Comparison of an exercise and relaxation intervention to a wait-list control condition
|
|
Ingen indgriben: Wait List Control Condition
Participants in this arm will be offered the exercise and relaxation intervention after a 12 week delay.
|
Comparison of an exercise and relaxation intervention to a wait-list control condition
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Feasibility measure: number of counseling sessions delivered
Tidsramme: 12 weeks
|
12 weeks
|
|
Acceptabilitetsmål: svar på punktet "Hvor tilfreds var du generelt med interventionen?"
Tidsramme: 12 uger
|
12 uger
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Referater af moderat intensitet aktivitet på syv dages PAR
Tidsramme: 12 uger
|
12 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carolyn Rabin, PhD, The Miriam Hospital
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. juli 2009
Primær færdiggørelse (Forventet)
1. december 2013
Studieafslutning (Forventet)
1. december 2013
Datoer for studieregistrering
Først indsendt
2. december 2008
Først indsendt, der opfyldte QC-kriterier
2. december 2008
Først opslået (Skøn)
3. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. april 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2012
Sidst verificeret
1. april 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 09-091-01-CPPB
- MRSG-09-091-01-CPPB
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 .
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