Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles_kamen@urmc.rochester.edu', 'phone': '585-275-9958', 'title': 'Dr. Charles Kamen', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, this was a pilot, Phase I trial, and hence had a limited sample size. This study was conducted in a single geographic region. Finally, we analyzed only two time points: baseline and post-intervention.'}}, 'adverseEventsModule': {'timeFrame': '2 years, 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Individual Exercise Intervention - Cancer Survivors', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dyadic Exercise Intervention - Cancer Survivors', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Individual Exercise Intervention - Caregivers', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dyadic Exercise Intervention - Caregivers', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': '1 mm segment depression in EKG', 'notes': '1 mm ST segment depression in Lead II at the end of treadmill test, therefore it was immediately terminated. He was not feeling any discomfort or pain, but because of known heart disease, the exercise physiologist thought it would be best.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'notes': 'While exercising, exacerbated her back problems. She has since gone to Chiropractor and massage therapist to help ease pain. Was instructed to stop doing any resistance activity. She will no longer be doing any EXCAP exercises.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psychological Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'OG001', 'title': 'Dyadic Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '-.65', 'spread': '9.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'degrees of freedom=40', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).'}, {'type': 'SECONDARY', 'title': 'Immune Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'OG001', 'title': 'Dyadic Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'degrees of freedom=40', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Provision of Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'OG001', 'title': 'Dyadic Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.90', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'degrees of freedom=40', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individual Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'FG001', 'title': 'Dyadic Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Both cancer survivors and their caregivers were screened, consented, and randomized to one of two intervention arms (Individual Exercise or Dyadic Exercise). 22 cancer survivor/caregiver dyads were recruited (44 individuals).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Individual Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'BG001', 'title': 'Dyadic Exercise Intervention', 'description': 'Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.17', 'spread': '11.05', 'groupId': 'BG000'}, {'value': '53.90', 'spread': '12.59', 'groupId': 'BG001'}, {'value': '55.12', 'spread': '11.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-23', 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Provision of Social Support', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.'}], 'primaryOutcomes': [{'measure': 'Psychological Distress', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.'}], 'secondaryOutcomes': [{'measure': 'Immune Biomarkers', 'timeFrame': 'Baseline to post-intervention (6 weeks later)', 'description': 'We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.', 'detailedDescription': 'This was a pilot feasibility study to refine our methodology before a larger Phase II trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Cancer Survivors:\n\n* Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.\n* Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments\n* Have a caregiver willing to participate int he study\n* Be able to read English\n* Be 21 years of age or older\n* Give written informed consent\n\nInclusion Criteria for Caregivers:\n\n* Be nominated by a cancer survivor\n* Be able to read English\n* Be 21 years of age or older\n* Give written informed consent\n\nExclusion Criteria:\n\n* have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.\n* For caregivers, be currently undergoing active treatment for cancer'}, 'identificationModule': {'nctId': 'NCT01883635', 'briefTitle': 'Exercise Intervention for Cancer Survivors and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Dyadic Exercise Intervention for Cancer Survivors and Caregivers', 'orgStudyIdInfo': {'id': '46413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Exercise Intervention', 'description': 'Survivor-only progressive walking and resistance exercise', 'interventionNames': ['Behavioral: Survivor-only progressive walking and resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Dyadic Exercise Intervention', 'description': 'Dyadic progressive walking and resistance exercise', 'interventionNames': ['Behavioral: Dyadic progressive walking and resistance exercise']}], 'interventions': [{'name': 'Survivor-only progressive walking and resistance exercise', 'type': 'BEHAVIORAL', 'otherNames': ['EXCAP'], 'description': 'Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only', 'armGroupLabels': ['Individual Exercise Intervention']}, {'name': 'Dyadic progressive walking and resistance exercise', 'type': 'BEHAVIORAL', 'otherNames': ['EXCAP-PA'], 'description': 'Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad', 'armGroupLabels': ['Dyadic Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Charles Kamen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Professor', 'investigatorFullName': 'Charles Kamen', 'investigatorAffiliation': 'University of Rochester'}}}}