Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428905
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
This phase III trial studies how well a telehealth self-management program works in improving survivorship care and outcomes in stage I-III non-small cell lung cancer or colorectal cancer survivors. Survivor self-management program focuses on coaching patients on follow-up care after cancer treatments. Participating in the program may improve knowledge and confidence about follow-up care, communication with cancer care and primary care doctors, and quality of life after cancer treatment in non-small cell lung cancer or colorectal cancer survivors.

Condition or disease Intervention/treatment Phase
Lung Non-Small Cell Carcinoma Stage I Colorectal Cancer AJCC v8 Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage II Colorectal Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIA Colorectal Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Colorectal Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 Stage IIC Colorectal Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survivorship Care Plan Other: Telemedicine Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the efficacy of the intervention on care coordination, communication, and primary care provider (PCP) knowledge, comparing the intervention and attention control arms at 4 and 8 months post-accrual.

II. Determine the efficacy of the intervention on survivor outcomes, comparing the intervention and attention control arms at 4 and 8 months post-accrual.

EXPLORATORY OBJECTIVE:

I. Assess the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (SURVIVOR SELF-MANAGEMENT): Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP.

ARM II (ATTENTION CONTROL): Patients receive an American Society of Clinical Oncology (ASCO) care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to review a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.

After study initiation, patients are followed up at 4 and 8 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancers
Actual Study Start Date : July 11, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (personalized care plan, telehealth sessions)
Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survivorship Care Plan
Receive personalized care plan/resource manual

Other: Telemedicine
Participate in telehealth sessions
Other Name: Telehealth

Active Comparator: Arm II (ASCO care plan, telehealth sessions)
Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Telemedicine
Participate in telehealth sessions
Other Name: Telehealth




Primary Outcome Measures :
  1. Care coordination [ Time Frame: At Baseline ]

    To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at baseline. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.

    Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.


  2. Care coordination [ Time Frame: At 4 months ]

    To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 4 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.

    Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.


  3. Care coordination [ Time Frame: At 8 months ]

    To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 8 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.

    Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.


  4. Oncologist/primary care providers (PCP) communication [ Time Frame: At Baseline ]

    To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at baseline (within group).

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  5. Oncologist/primary care providers (PCP) communication [ Time Frame: At 4 months ]

    To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 4 months (within group).

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  6. Oncologist/primary care providers (PCP) communication [ Time Frame: At 8 months ]

    To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 8 months (within group).

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  7. PCP knowledge in survivorship care [ Time Frame: At Baseline ]

    To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  8. PCP knowledge in survivorship care [ Time Frame: At 4 months ]

    To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  9. PCP knowledge in survivorship care [ Time Frame: At 8 months ]

    To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.

    Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better


  10. Survivor outcomes [ Time Frame: At Baseline ]

    Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at baseline into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.

    Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better


  11. Survivor outcomes [ Time Frame: At 4 months ]

    Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 4 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.

    Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better


  12. Survivor outcomes [ Time Frame: At 8 months ]

    Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 8 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.

    Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better


  13. Patient-centered communication [ Time Frame: At Baseline ]

    To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at baseline , controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.

    Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better


  14. Patient-centered communication [ Time Frame: At 4 months ]

    To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 4 months (short-term, primary effect), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.

    Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better


  15. Patient-centered communication [ Time Frame: At 8 months ]

    To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.

    Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better


  16. Quality of life: survey [ Time Frame: At Baseline ]

    A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at baseline, controlling for the baseline measure of patients' quality of life.

    Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better


  17. Quality of life: survey [ Time Frame: At 4 months ]

    A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 4 months (short-term, primary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.

    Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better


  18. Quality of life: survey [ Time Frame: At 8 months ]

    A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.

    Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better



Other Outcome Measures:
  1. Overall reach (participation rate) with primary care providers (Arm I) [ Time Frame: Up to 8 months ]
    Data analysis will be primarily descriptive. Records from the tracking database will be examined and used to understand the extent to which patients' primary care providers assigned to the intervention arm participated in all aspects of the intervention.

  2. Percentage of primary care providers who received a clinical care plan (Arm I) [ Time Frame: Up to 8 months ]
    Data analysis will be primarily descriptive. Data from the tracking database will also be used to understand the percentage of primary care providers who received a clinician care plan.

  3. Primary care providers' use of care plan information for survivorship care (Arm I) [ Time Frame: Up to 8 months ]
    Data analysis will be primarily descriptive. Primary care provider survivor clinical visit notes will also be used to qualitatively assess primary care providers' use of the clinician care plan information to provide quality survivorship care to also understand the level of adoption of the intervention.

  4. Potential barriers and facilitators for intervention implementation and maintenance [ Time Frame: Up to 8 months ]
    Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.

  5. Outcome Measure for facilitators [ Time Frame: Up to 8 months ]
    Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-small cell lung cancer (NSCLC) and colorectal cancer survivors who are 4 months post-treatment completion
  • History of stage I-III disease
  • Ability to read or understand English
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428905


Locations
Layout table for location information
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Virginia Sun    626-256-4673    VSun@coh.org   
Principal Investigator: Virginia Sun         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Virginia Sun City of Hope Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04428905    
Other Study ID Numbers: 19556
NCI-2020-03375 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19556 ( Other Identifier: City of Hope Medical Center )
R01CA249501 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms