<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01734499</url>
  </required_header>
  <id_info>
    <org_study_id>A12-3719</org_study_id>
    <nct_id>NCT01734499</nct_id>
  </id_info>
  <brief_title>The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors</brief_title>
  <acronym>CCIP</acronym>
  <official_title>The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is proposed to assess long-term Quality of Life issues in breast cancer survivors&#xD;
      by measuring the impact on the quality of life made by the structured &quot;Change Cycle Work&#xD;
      Shop&quot; coping class as compared to current local standard of care programs. It has been shown&#xD;
      that breast cancer treatment can have long-term bio-psychosocial consequences. Specific&#xD;
      evidence-based interventions are needed to address Quality of Life concerns in order to&#xD;
      improve the overall outcome of breast cancer and its treatment beyond the focus on mortality&#xD;
      rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the most common cancer among North American women. A combination of&#xD;
      screening mammography and improvements in treatment has resulted in a substantial decrease in&#xD;
      mortality which explains why more women diagnosed at a younger age are becoming long-term&#xD;
      survivors.Consequently, quality of life (QL) issues have become increasingly important in the&#xD;
      contemporary multidisciplinary management of breast cancer. Standard of car survivorship&#xD;
      program has evolved over several years to include 3 facets: (1)clinical surveillance program&#xD;
      to include routine follow up exams; (2) local support group programs; and (3) rehabilitation&#xD;
      program offering physical and occupational rehab, along with lymphedema prevention and&#xD;
      treatment.&#xD;
&#xD;
      Many studies have reported on successful interventions (listed in our references) with&#xD;
      improvements in quality of life; however the effects did not last long after intervention.&#xD;
      This has brought into question the real value of such interventions. The proposed class will&#xD;
      focus on teaching life skills that have shown long-lasting effect in the corporate world of&#xD;
      change. Thus, our goal is to determine if the impact of the class will be similar in the&#xD;
      healthcare arena, specifically cancer survivorship. Our last study on assessing quality of&#xD;
      life revealed that patients were suffering deficits in quality of life, specifically with&#xD;
      regard to the emotional scale despite the standard of care approach available. We therefore&#xD;
      propose this intervention to be studied as proof of concept so that depending on the results&#xD;
      of the proposed trial, this class can become a routine part of the survivorship program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>change from Baseline and at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>change from Baseline and at 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>change from Baseline and at 18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>change from Baseline and at 24 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Coping Class</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 4-hour structured program which will be offered once a month as the &quot;Coping Class&quot; by a certified facilitator of &quot;The Change Cycle.&quot; Quality of Life survey completed at 5 time points after informed consent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coping Class</intervention_name>
    <description>A 4-hour structured program which will be offered once a month as the &quot;Coping Class&quot; by a certified facilitator of &quot;The Change Cycle.&quot; The coping class uses standardized materials and skills training. Standardized materials for the intervention arm will include &quot;Change Moves Me&quot; 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 &quot;act as if&quot; philosophy, guiding participants through each stage of The Change Cycle, irrespective of which stage they are actually in.</description>
    <arm_group_label>Coping Class</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FACT-B Quality of Life</intervention_name>
    <description>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).</description>
    <arm_group_label>Coping Class</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  established diagnosis of breast cancer&#xD;
&#xD;
          -  diagnosis from January 2010 onward&#xD;
&#xD;
          -  must be patient of Texas Tech University Health Sciences Center-Breast Center of&#xD;
             Excellence&#xD;
&#xD;
          -  must agree to participate in study structure of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who do not accept randomization&#xD;
&#xD;
          -  women with medical conditions that preclude them from attending the coping class&#xD;
&#xD;
          -  women with personal issues that preclude them from attending the coping class&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakhshanda L Rahman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center-Amarillo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/uscs</url>
    <description>United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report.</description>
  </link>
  <link>
    <url>http://www.changecycle.com</url>
    <description>Change Cycle</description>
  </link>
  <reference>
    <citation>U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2009.http://www.cdc.gov/uscs.</citation>
  </reference>
  <reference>
    <citation>http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-and-figures-2010 (accessed on 9/10/2011).</citation>
  </reference>
  <reference>
    <citation>http://statecancerprofiles.cancer.gov/prevalence/index.php?</citation>
  </reference>
  <reference>
    <citation>Garfinkel L, Boring CC, Heath CW Jr. Changing trends. An overview of breast cancer incidence and mortality. Cancer. 1994 Jul 1;74(1 Suppl):222-7. doi: 10.1002/cncr.2820741304.</citation>
    <PMID>8004590</PMID>
  </reference>
  <reference>
    <citation>De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217.</citation>
    <PMID>19248047</PMID>
  </reference>
  <reference>
    <citation>Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.</citation>
    <PMID>19001605</PMID>
  </reference>
  <reference>
    <citation>American Cancer Society. Cancer Facts and Figures 2009. American Cancer society: Atlanta, GA, 2009</citation>
  </reference>
  <reference>
    <citation>Meyerowitz BE. Psychosocial correlates of breast cancer and its treatments. Psychol Bull. 1980 Jan;87(1):108-31. No abstract available.</citation>
    <PMID>7375595</PMID>
  </reference>
  <reference>
    <citation>Glanz K, Lerman C. Psychosocial impact of breast cancer: A critical review. Ann Behav Med 14:204-212, 1992</citation>
  </reference>
  <reference>
    <citation>Bloom JR, Stewart SL, Chang S, Banks PJ. Then and now: quality of life of young breast cancer survivors. Psychooncology. 2004 Mar;13(3):147-60. doi: 10.1002/pon.794.</citation>
    <PMID>15022150</PMID>
  </reference>
  <reference>
    <citation>Ganz PA, Desmond KA, Leedham B, Rowland JH, Meyerowitz BE, Belin TR. Quality of life in long-term, disease-free survivors of breast cancer: a follow-up study. J Natl Cancer Inst. 2002 Jan 2;94(1):39-49. doi: 10.1093/jnci/94.1.39. Erratum In: J Natl Cancer Inst 2002 Mar 20;94(6):463.</citation>
    <PMID>11773281</PMID>
  </reference>
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    <citation>Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.</citation>
    <PMID>21656954</PMID>
  </reference>
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    <citation>Calman KC. Definitions and dimensions of quality of life. In Quality of life of cancer patients, Aaronson NK, Beckmann J (eds). Raven Press: New York, 1987; 1-10</citation>
  </reference>
  <reference>
    <citation>Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.</citation>
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  </reference>
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  </reference>
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    <citation>McCaul KD, Sandgren AK, King B, O'Donnell S, Branstetter A, Foreman G. Coping and adjustment to breast cancer. Psychooncology. 1999 May-Jun;8(3):230-6. doi: 10.1002/(SICI)1099-1611(199905/06)8:33.0.CO;2-#.</citation>
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  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 19, 2016</last_update_submitted>
  <last_update_submitted_qc>April 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Survivorship</keyword>
  <keyword>Coping</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734499
org study id: A12-3719
nct id: NCT01734499
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quality of Life Questionnaire
time frame: Baseline
measure: Quality of Life Questionnaire
time frame: change from Baseline and at 6 months
measure: Quality of Life Questionnaire
time frame: change from Baseline and at 12 months
measure: Quality of Life Questionnaire
time frame: change from Baseline and at 18 months
measure: Quality of Life Questionnaire
time frame: change from Baseline and at 24 months
arm group label: Coping Class
arm group type: Experimental
description: 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.
arm group label: Standard of Care
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Coping Class
description: 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.
arm group label: Coping Class
intervention type: Behavioral
intervention name: Standard of Care
description: 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.
arm group label: Standard of Care
intervention type: Behavioral
intervention name: FACT-B Quality of Life
description: 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).
arm group label: Coping Class
arm group label: Standard of Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rakhshanda L Rahman, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center-Amarillo
facility: 
country: United States
url: http://www.cdc.gov/uscs
description: United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report.
url: http://www.changecycle.com
description: Change Cycle
citation: U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2005 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2009.http://www.cdc.gov/uscs.
citation: http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-and-figures-2010 (accessed on 9/10/2011).
citation: http://statecancerprofiles.cancer.gov/prevalence/index.php?
citation: Garfinkel L, Boring CC, Heath CW Jr. Changing trends. An overview of breast cancer incidence and mortality. Cancer. 1994 Jul 1;74(1 Suppl):222-7. doi: 10.1002/cncr.2820741304.
PMID: 8004590
citation: De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217.
PMID: 19248047
citation: Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.
PMID: 19001605
citation: American Cancer Society. Cancer Facts and Figures 2009. American Cancer society: Atlanta, GA, 2009
citation: Meyerowitz BE. Psychosocial correlates of breast cancer and its treatments. Psychol Bull. 1980 Jan;87(1):108-31. No abstract available.
PMID: 7375595
citation: Glanz K, Lerman C. Psychosocial impact of breast cancer: A critical review. Ann Behav Med 14:204-212, 1992
citation: Bloom JR, Stewart SL, Chang S, Banks PJ. Then and now: quality of life of young breast cancer survivors. Psychooncology. 2004 Mar;13(3):147-60. doi: 10.1002/pon.794.
PMID: 15022150
citation: Ganz PA, Desmond KA, Leedham B, Rowland JH, Meyerowitz BE, Belin TR. Quality of life in long-term, disease-free survivors of breast cancer: a follow-up study. J Natl Cancer Inst. 2002 Jan 2;94(1):39-49. doi: 10.1093/jnci/94.1.39. Erratum In: J Natl Cancer Inst 2002 Mar 20;94(6):463.
PMID: 11773281
citation: Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.
PMID: 21656954
citation: Calman KC. Definitions and dimensions of quality of life. In Quality of life of cancer patients, Aaronson NK, Beckmann J (eds). Raven Press: New York, 1987; 1-10
citation: Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PMID: 9060536
citation: Stanton AL, Danoff-Burg S, Cameron CL, Bishop M, Collins CA, Kirk SB, Sworowski LA, Twillman R. Emotionally expressive coping predicts psychological and physical adjustment to breast cancer. J Consult Clin Psychol. 2000 Oct;68(5):875-82.
PMID: 11068973
citation: McCaul KD, Sandgren AK, King B, O'Donnell S, Branstetter A, Foreman G. Coping and adjustment to breast cancer. Psychooncology. 1999 May-Jun;8(3):230-6. doi: 10.1002/(SICI)1099-1611(199905/06)8:33.0.CO;2-#.
PMID: 10390735
citation: Schnoll RA, Harlow LL, Stolbach LL, Brandt U. A structural model of the relationships among stage of disease, age, coping, and psychological adjustment in women with breast cancer. Psychooncology. 1998 Mar-Apr;7(2):69-77. doi: 10.1002/(SICI)1099-1611(199803/04)7:23.0.CO;2-8.
PMID: 9589505
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responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No