- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04064892
Physical Activity Intervention for Young Cancer Survivors
Physical Activity Interventions for Young Cancer Survivors
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Young breast cancer survivors (i.e. those < 50 years old) have lower survival rates than their older counterparts and experience unique physical and mental challenges associated with their cancer treatments. Depression, anxiety, and poor body image are common in young breast cancer survivors. Research in older breast cancer survivors has shown that physical activity can decrease cancer recurrence and mortality, and improve many aspects of quality of life. Few physical activity intervention studies have been conducted in young breast cancer survivors, despite the fact that young survivors would be best served by age-specific interventions designed to target their needs. Remotely-delivered, technology-based interventions may be important to help young breast cancer survivors overcome unique barriers to increasing physical activity and improving quality of life.
The study aims are: 1) Explore the feasibility and acceptability of a technology-based, remotely-delivered, peer-moderated physical activity intervention for young breast cancer survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure the intervention's effect on multiple aspects of quality of life
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
La Jolla, California, Forenede Stater, 92093
- University of California, San Diego
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosed with breast cancer between 18-49 years old
- Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment
- Self-report low levels of moderate to vigorous physical activity each week
- Accessible by phone or video chat
- Have a Fitbit compatible cellphone, tablet, or laptop with Internet
Exclusion Criteria:
- medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
- currently pregnant
- unable to commit to intervention schedule
- prisoner
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Exercise Intervention
Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention
|
The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, & Fitbit message board) to support behavior change.
All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly.
Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physical Activity
Tidsramme: Baseline to 12 weeks
|
The ActiGraph GT3X+ accelerometer will be used to measure change in minutes of moderate to vigorous physical activity from baseline to 12 weeks.
For 7 days around each assessment time point, participants will wear the accelerometer.
|
Baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body Image Scale
Tidsramme: Baseline to 12 weeks
|
The Body Image Scale will be used to measure changes in perceptions of body image from baseline to 12 weeks.
Scores range from 0 to 30.
A higher score indicates more distress.
|
Baseline to 12 weeks
|
Female Sexual Function Index
Tidsramme: Baseline to 12 weeks
|
The Female Sexual Function Index will be used to measure change in self-reported sexual functioning from baseline to 12 weeks.
Scores range from 2 to 36.
A higher score indicates fewer problems with sexual functioning.
|
Baseline to 12 weeks
|
PROMIS Cancer - Fatigue
Tidsramme: Baseline to 12 weeks
|
Change in fatigue from baseline to 12 weeks will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT), PROMIS Cancer- Fatigue.
CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers.
Participants will complete 4-12 items.
This measure yields a T-Score with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of fatigue.
|
Baseline to 12 weeks
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 181367
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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