Redes III Patient Navigator Qol Study
Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Illinois
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Chicago, Illinois, Forenede Stater, 60201
- Northwestern University
-
-
Texas
-
San Antonio, Texas, Forenede Stater, 78229
- The University of Texas Health Science Center at San Antonio
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Self identified Hispanic/Latino
- At least 18 yrs old
- Fluent in spoken Spanish or English
- Diagnosed with breast, prostate or colorectal cancer within the past fifteen months and thus considered a cancer survivor and are currently not undergoing treatment, with the exception of hormone therapy for prostate patients
- No evidence of metastatic disease
- No current severe mental illness
- No substance dependence within the past year -
Exclusion Criteria:
- Does not meet inclusion criteria
- Psychotic Disorder
- Active Suicidal Ideation
- Substance dependence (alcohol/drugs) within the past 12 months
- Does not meet the requisite cutoff of 3 or more correct responses on SPMSQ (Short Portable Mental Status Questionnaire)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: PN+LCNC
Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
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Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
|
|
Aktiv komparator: PN only
Patient Navigation ONLY.
Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
Navigation will occur ONLY on contact with navigators initiated by the study participants.
|
Participants will be navigated by PN on request
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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General quality of life
Tidsramme: 15 months
|
The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to evaluate general domains of QOL.
The FACT-G, now in its fourth revision, is one of the most widely used instruments to assess overall adjustment to cancer treatment and survivorship.
It is a 27-item self-report questionnaire that takes less than 15 minutes to administer.
The FACT-G assesses QOL in four domains of well-being: physical, social/family, emotional and functional well-being.
Patients are asked to indicate the extent to which they agree with statements such as "I have pain," "I feel ill," "I get emotional support from my family," "I get support from my friends," "I feel sad," "I feel nervous," "I am sleeping well," and "I am content with the quality of my life right now."
The scale is validated for use in many settings with many age groups.
We will calculate a composite score for general QOL as well as subscale scores for specific domains of QOL.
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15 months
|
|
Disease specific quality of life
Tidsramme: 15 months
|
We will administer three cancer-specific FACT versions, the FACT-B (breast cancer survivors), FACT-C (colorectal cancer survivors) or FACT-P (prostate cancer survivors).
Each version addresses QOL issues that are common sequelae of that certain cancer.
For example, the FACT-P evaluates concerns on sexuality, pain, and bowel and bladder function, the FACT-C asks questions about bowel movement control, weight loss and cramping in the abdominal area, and the FACT-B inquires about hair loss, shortness of breath and swelling in the arms.
Reliability of the FACT-G, as well as all cancer site-specific FACT measures are acceptable (Cronbach's α>.70).
Composite scores for disease-specific QOL will be calculated across each cancer site.
Cancer site specific modules scores are standardized and can be combined across cancer sites.
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15 months
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Treatment Follow-up compliance
Tidsramme: 15 months
|
Because all of our HL cancer survivors will be recruited within 12-months post-treatment completion for a primary tumor, we will follow ACS guidelines for follow-up care for one- to two-years post-treatment.
We will assess via self-report whether the participant missed a scheduled follow-up appointment during the study period.
A compliance categorical outcome measure (compliant vs. non-compliant) will be calculated for each participant.
Compliance will be defined as attending all scheduled follow-up appointments specific to cancer treatment follow-up during the study period.
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15 months
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Amelie G Ramirez, DRPH, The University of Texas Health Science Center at San Antonio
- Studieleder: Frank Penedo, PhD, Northwestern University
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HSC20110094H
- U54CA153511 (U.S. NIH-bevilling/kontrakt)
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