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The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors (CCIP)

19. april 2016 oppdatert av: Texas Tech University Health Sciences Center
This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured "Change Cycle Work Shop" coping class as compared to current local standard of care programs. It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences. Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Breast cancer is the most common cancer among North American women. A combination of screening mammography and improvements in treatment has resulted in a substantial decrease in mortality which explains why more women diagnosed at a younger age are becoming long-term survivors.Consequently, quality of life (QL) issues have become increasingly important in the contemporary multidisciplinary management of breast cancer. Standard of car survivorship program has evolved over several years to include 3 facets: (1)clinical surveillance program to include routine follow up exams; (2) local support group programs; and (3) rehabilitation program offering physical and occupational rehab, along with lymphedema prevention and treatment.

Many studies have reported on successful interventions (listed in our references) with improvements in quality of life; however the effects did not last long after intervention. This has brought into question the real value of such interventions. The proposed class will focus on teaching life skills that have shown long-lasting effect in the corporate world of change. Thus, our goal is to determine if the impact of the class will be similar in the healthcare arena, specifically cancer survivorship. Our last study on assessing quality of life revealed that patients were suffering deficits in quality of life, specifically with regard to the emotional scale despite the standard of care approach available. We therefore propose this intervention to be studied as proof of concept so that depending on the results of the proposed trial, this class can become a routine part of the survivorship program.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Texas Tech University Health Sciences Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • female
  • 18 years old or older
  • established diagnosis of breast cancer
  • diagnosis from January 2010 onward
  • must be patient of Texas Tech University Health Sciences Center-Breast Center of Excellence
  • must agree to participate in study structure of randomization

Exclusion Criteria:

  • those who do not accept randomization
  • women with medical conditions that preclude them from attending the coping class
  • women with personal issues that preclude them from attending the coping class

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Coping Class
A 4-hour structured program which will be offered once a month as the "Coping Class" by a certified facilitator of "The Change Cycle." Quality of Life survey completed at 5 time points after informed consent.
Atferdsmessig: Coping Class
A 4-hour structured program which will be offered once a month as the "Coping Class" by a certified facilitator of "The Change Cycle." The coping class uses standardized materials and skills training. Standardized materials for the intervention arm will include "Change Moves Me" Participant's Guide/Journal, Locator Assessment Profile, The Change Cycle Color Model, and class evaluation. The structure of the class includes a profile of each stage to gain perspective and understanding, teaching personal change skills for each stage and a primary focus for movement to the next stage. The overall design follows an "act as if" philosophy, guiding participants through each stage of The Change Cycle, irrespective of which stage they are actually in.
Atferdsmessig: FACT-B Quality of Life
The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument. The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).
Aktiv komparator: Standard of Care
Standard of Care. Three components of this: (1)Surveillance Program, (2)Local support groups centered at community cancer centers, (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation.Quality of Life surveys completed at 5 time points after informed consent.
Atferdsmessig: FACT-B Quality of Life
The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument. The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).
Atferdsmessig: Standard of Care
Standard of Care. Three components of this: (1)Surveillance Program: all patients diagnosed with breast cancer are seen every six months for the first two years and yearly thereafter to rule out disease recurrence by history and physical exam at each visit in addition to the annual mammogram. (2)Local support groups centered at community cancer centers. These are generally attended by 12-16 women monthly; all breast cancer patients receive the information about these groups. Associated with these programs, some classes are offered sporadically in nutrition, and exercise. (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation to all women, thus provides prevention and treatment of lymphedema and monitored shoulder range of motion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Quality of Life Questionnaire
Tidsramme: Baseline
Baseline
Quality of Life Questionnaire
Tidsramme: change from Baseline and at 6 months
change from Baseline and at 6 months
Quality of Life Questionnaire
Tidsramme: change from Baseline and at 12 months
change from Baseline and at 12 months
Quality of Life Questionnaire
Tidsramme: change from Baseline and at 18 months
change from Baseline and at 18 months
Quality of Life Questionnaire
Tidsramme: change from Baseline and at 24 months
change from Baseline and at 24 months

Samarbeidspartnere og etterforskere

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Sponsor

Texas Tech University Health Sciences Center

Etterforskere

  • Hovedetterforsker: Rakhshanda L Rahman, MD, Texas Tech University Health Sciences Center-Amarillo

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

21. november 2012

Først innsendt som oppfylte QC-kriteriene

26. november 2012

Først lagt ut (Anslag)

27. november 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A12-3719

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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