Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-03 @ 2:30 AM
Study NCT ID:
NCT02129569
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2014-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in emotional distress in patients measured as anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used and the model parameters will be estimated by the method of restricted maximum likelihood.'}], 'secondaryOutcomes': [{'measure': 'Change in activation for self-management in patients using the Patient Activation Measure (PAM)', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in activation for self-management in caregivers using the PAM', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in fatigue in patients using the PROMIS', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in fatigue in caregivers using the PROMIS', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in depression in patients using the PROMIS', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in depression in caregivers using the PROMIS', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in HRQOL in patients using the PROMIS short form, Global Health', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Change in HRQOL in caregivers using the PROMIS short form, Global Health', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.'}, {'measure': 'Feasibility of the intervention, assessed via attrition rates', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Acceptability of the intervention, assessed via consent rates', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Satisfaction with the intervention assessed using an exit interview survey', 'timeFrame': 'At 12 weeks'}, {'measure': 'Integrity of the intervention, assessed through fidelity monitoring', 'timeFrame': 'Up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well psychoeducational and behavioral strategies work in reducing distress and anxiety in patients with multiple myeloma and their family caregivers. Education and walking programs, may be able to reduce distress and anxiety and improve the well-being and quality of life of patients with multiple myeloma and their family caregivers. Understanding how different forms of education and support can promote emotional wellness may help nurse researchers find ways to improve services provided to patients and family members during cancer treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate the effect of the intervention, as compared to the control group, on emotional distress, the primary outcome, measured as anxiety in patients with multiple myeloma and their caregivers at the transition.\n\nII. Evaluate the effect, including the effect size, of the intervention, as compared to the control group, on activation for self-management, fatigue, depression, and health-related quality of life (HRQOL) in both patients and caregivers.\n\nIII. Assess the feasibility, acceptability, and content integrity of the intervention in patients with multiple myeloma and their family caregivers.\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I: Participants meet with a nurse in-person for approximately 30 minutes to receive information about strategies for cognitive self-management of distress and an individualized walking prescription to gradually increase their walking to 30 minutes per day, 5 times per week. Participants wear a pedometer for at least 3 consecutive days during weeks 1, 6, and 12. Participants are also contacted by the nurse via telephone at 1 and 3 weeks for supplemental counseling support.\n\nARM II: Participants meet with a nurse in-person for approximately 20 minutes to receive National Cancer Institute (NCI) educational booklets and a link to the American Cancer Society (ACS) website. Participants are also contacted by the nurse via telephone at 1 and 3 weeks but the calls are primarily social in nature and do not include counseling support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENTS: Within 12 months of a new diagnosis of multiple myeloma or less than or equal to 2 cycles of treatment (all stages, with or without treatment)\n* PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2\n* PATIENTS: Ambulatory with or without an assistive device (cane, walker)\n* PATIENTS: Cognitively intact, as evidenced by orientation to person, place, and time\n* PATIENTS: Ability to speak, read, and comprehend English\n* PATIENTS: Has an identified family caregiver who is willing to participate\n* CAREGIVERS: Any family member, who is identified by the patient as his/her caregiver\n* CAREGIVERS: ECOG performance status less than or equal to 2\n* CAREGIVERS: Ambulatory with or without an assistive device (cane, walker)\n* CAREGIVERS: Cognitively intact, as evidenced by orientation to person, place, and time\n* CAREGIVERS: Ability to speak, read, and comprehend English\n* CAREGIVERS: Has an identified family member who is a patient\n* CAREGIVERS: Caregivers do not need to reside with the patient\n\nExclusion Criteria:\n\n* PATIENTS: Have severe pain (pain score of 7 to 10 on a 0 to 10 scale)\n* PATIENTS: Are at high risk for bone fracture or who have a new fracture needing intervention, as determined by the physician\n* PATIENTS: Have untreated venous thrombosis, as determined by the physician\n* PATIENTS: Have a life expectancy of less than six months, as determined by the physician, and their caregivers\n* PATIENTS: Receiving active, concurrent treatment for a prior history of cancer (hormonal therapies allowed)\n* CAREGIVERS: Diagnosis of cancer and received cancer treatment within one year\n* CAREGIVERS: Medical condition that significantly affects their ability to walk\n* PATIENT or CAREGIVER: Is hearing impaired to the degree that they are unable to hear instructions via the phone\n* PATIENTS or CAREGIVER: Lives in a skilled nursing facility'}, 'identificationModule': {'nctId': 'NCT02129569', 'briefTitle': 'Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness', 'orgStudyIdInfo': {'id': 'CASE5A13'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00836', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CASE 5A13', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (psychoeducational and behavioral interventions)', 'description': 'Participants meet with a nurse in-person for approximately 30 minutes to receive information about strategies for cognitive self-management of distress and an individualized walking prescription to gradually increase their walking to 30 minutes per day, 5 times per week. Participants wear a pedometer for at least 3 consecutive days during weeks 1, 6, and 12. Participants are also contacted by the nurse via telephone at 1 and 3 weeks for supplemental counseling support.', 'interventionNames': ['Other: Psychoeducational intervention', 'Behavioral: behavioral intervention', 'Other: counseling intervention', 'Other: questionnaire administration', 'Other: quality-of-life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (control)', 'description': 'Participants meet with a nurse in-person for approximately 20 minutes to receive NCI educational booklets and a link to the ACS website. Participants are also contacted by the nurse via telephone at 1 and 3 weeks but the calls are primarily social in nature and do not include counseling support.', 'interventionNames': ['Other: educational intervention', 'Other: telephone-based intervention', 'Other: questionnaire administration', 'Other: quality-of-life assessment']}], 'interventions': [{'name': 'Psychoeducational intervention', 'type': 'OTHER', 'description': 'Receive information about strategies for cognitive self-management of distress', 'armGroupLabels': ['Arm I (psychoeducational and behavioral interventions)']}, {'name': 'behavioral intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'Behavior Therapy', 'Behavioral Modification', 'Behavioral Therapy', 'Behavioral Treatment'], 'description': 'Receive individualized walking prescription and wear pedometer', 'armGroupLabels': ['Arm I (psychoeducational and behavioral interventions)']}, {'name': 'counseling intervention', 'type': 'OTHER', 'otherNames': ['counseling and communications studies'], 'description': 'Receive supplemental counseling support over the phone', 'armGroupLabels': ['Arm I (psychoeducational and behavioral interventions)']}, {'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive NCI educational booklets and a link to the ACS website', 'armGroupLabels': ['Arm II (control)']}, {'name': 'telephone-based intervention', 'type': 'OTHER', 'description': 'Receive calls that are primarily social in nature', 'armGroupLabels': ['Arm II (control)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (psychoeducational and behavioral interventions)', 'Arm II (control)']}, {'name': 'quality-of-life assessment', 'type': 'OTHER', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (psychoeducational and behavioral interventions)', 'Arm II (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Susan Mazanec', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}