Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 9:44 AM
Study NCT ID:
NCT06982066
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of implementing the ReSPECT intervention.', 'timeFrame': '2 months', 'description': 'Feasibility will be based on patient recruitment and completion of the intervention. The intervention will be considered feasible if AYA recruitment is greater than or equal to 60% and if greater than or equal to 80% of consented AYAs complete the intervention (retention). Intervention completion will be defined as AYA completion of the pre-visit questionnaire and post-intervention survey.'}, {'measure': 'Acceptability of the ReSPECT intervention.', 'timeFrame': '2 months', 'description': 'The intervention will be considered acceptable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as acceptable (average score of 4 or higher) on the Lyon Satisfaction Questionnaire, adapted for this study, which includes a 10-item satisfaction questionnaire where 1 is strongly disagree and 5 is strongly agree. Subjects will report via survey after the healthcare visit.'}, {'measure': 'Usability of the ReSPECT intervention.', 'timeFrame': '2 months', 'description': 'The intervention will be considered usable/sustainable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as usable (average score of 4 or higher) on the Usability/Sustainability of Intervention Scale, adapted for this study, on a 4-item usability questionnaire where 1 is strongly disagree and 5 is completely agree. Subjects will report via survey after the healthcare visit.'}, {'measure': 'Perceived utility of the ReSPECT intervention.', 'timeFrame': '2 months', 'description': 'Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.'}], 'secondaryOutcomes': [{'measure': 'Comparison of patient reported SRH communication before and after intervention implementation.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention percentage of patients reporting that their clinician talked to them about a SRH topic during the most recent clinic visit. Subjects will report via survey (yes/no) at baseline and after their healthcare visit.'}, {'measure': 'Comparison of clinician reported SRH communication before and after intervention implementation.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention percentage of clinicians reporting that they talked to their AYA patient about a SRH topic during the most recent clinic visit. Subjects will report (yes/no) via survey at baseline and after the healthcare visit.'}, {'measure': 'Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention patient report of confidence in talking to their oncology clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.'}, {'measure': 'Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention clinician report of confidence in talking to their AYA clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.'}, {'measure': 'Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention patient report of perceived benefit of discussing SRH with their clinician. Patients will complete a 6-item questionnaire adapted for this study on perceived benefit where 0 is "not at all" and 10 is "very much." Subjects will report via survey at baseline and after the healthcare visit.'}, {'measure': 'Intervention impact on decision-making.', 'timeFrame': '2 months', 'description': 'The proportion of patients that report the intervention helped them get the information that they needed to make informed decisions about SRH. Subjects will report (yes/no) via survey after their healthcare visit.'}, {'measure': 'Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.', 'timeFrame': '2 months', 'description': 'Comparison of pre- and post- intervention rating of distress/bother by SRH-related questions or concerns. Patients will complete a single item scale on the degree of bother on the Distress/Bother Scale where 1 is "Not at all bothersome" and 4 is "Bothers me a lot". Subjects will report via survey at baseline and after the healthcare visit.'}, {'measure': 'Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.', 'timeFrame': '2 months', 'description': 'Comparison of patient-reported engagement in sexual health risk behaviors pre- and post- intervention implementation. Patients will complete a study-specific survey consisting of several questions about engagement in sexual health risk behaviors (yes/no and nominal). Subjects will report via survey at baseline and after the healthcare visit.'}, {'measure': 'Comparison of patient-reported therapeutic alliance before and after the intervention.', 'timeFrame': '2 months', 'description': 'Comparison of patient-reported therapeutic alliance with primary oncology clinician pre- and post- intervention implementation. Patients will complete 16 items on The Human Connection Scale (4-point scale). Subjects will report via survey at baseline and after the healthcare visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent young adult', 'sexual health communication', 'cancer', 'patient provider communication', 'sexual and reproductive health'], 'conditions': ['Pediatric Cancer', 'Adolescent and Young Adult Cancer']}, 'descriptionModule': {'briefSummary': 'The overarching goal is to develop and demonstrate proof-of-concept of ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool), a multi-modal communication intervention to improve adolescent and young adult (AYA)- clinician sexual and reproductive health (SRH) communication in the outpatient oncology clinic setting.', 'detailedDescription': 'To improve sexual and reproductive health communication between adolescent and young adult oncology patients and their clinicians, the Investigator will be developing and testing proof-of-concept of a novel web-based intervention called ReSPECT (Reproductive and Sexual health Patient Education and Communication Tool). The overarching goal of this proposal is to develop and pilot test a patient-centered approach to improve sexual and reproductive health communication during cancer care.\n\nPrior to the clinical trial, Aim 1 of this study will develop and refine ReSPECT by integrating feedback from AYAs and pediatric oncology clinicians on individual intervention components followed by additional feedback collected through cognitive debriefing. Once Aim 1 is completed, the intervention will be ready for proof-of-concept testing.\n\nAims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nAdolescent and Young Adult Oncology Patients\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Be aged 15-25 years old at time of enrollment.\n2. Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:\n\n 1. Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.\n 2. Radiotherapy: any radiotherapy to treat the cancer diagnosis.\n 3. Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.\n3. Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.\n4. Be able to speak and read English\n5. Have permission to participate from a member of the patient's primary oncology team.\n6. Provision to sign and date the consent/assent form.\n7. Active study participation of primary oncology clinician\n8. Patient must have primary oncology care at Connecticut Children's Center for Cancer \\& Blood Disorders of Children's Hospital Los Angeles Cancer \\& Blood Disease Institute\n\nExclusion Criteria\n\nAn individual who meets and of the following criteria will be excluded from participation in this study:\n\n1. Not currently on cancer-directed therapy.\n2. Unable to speak and read English.\n3. Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)\n\nPediatric Oncology Clinicians\n\n1\\. Be a pediatric oncology physician, clinical fellow, or advanced practice provider (including nurse practitioners and physician assistants) that provides clinical care for AYA patients with cancer"}, 'identificationModule': {'nctId': 'NCT06982066', 'briefTitle': 'Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'Improving Health-Related Quality of Life Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention', 'orgStudyIdInfo': {'id': '24-081'}, 'secondaryIdInfos': [{'id': 'K08CA286736', 'link': 'https://reporter.nih.gov/quickSearch/K08CA286736', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReSPECT', 'description': 'Aims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.', 'interventionNames': ['Behavioral: ReSPECT']}], 'interventions': [{'name': 'ReSPECT', 'type': 'BEHAVIORAL', 'description': "ReSPECT is an interactive, web-based digital platform that integrates (1) an AYA-centered pre-visit questionnaire (PVQ) that will discretely alert clinicians to relevant SRH questions/concerns, (2) targeted patient education on PVQ selections, and (3) clinician-centered guidance for addressing SRH issues. At enrollment, all participants will complete a baseline survey (T1). AYAs will have access to the ReSPECT digital platform and will receive the first prompt to complete the PVQ 3-5 days before their next clinic appointment. Once completed, AYAs will receive an email/text with a link to tailored information based on their PVQ selections for review. Clinicians will receive an email with a link to the patient's PVQ results on the ReSPECT platform along with clinical management recommendations. All participants will complete a brief virtual survey (T2) and interview within 48 hours of the first postintervention clinic visit and a follow-up survey 2 months after study enrollment (T3).", 'armGroupLabels': ['ReSPECT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natasha Frederick, MD, MPH', 'role': 'CONTACT', 'email': 'nfrederick@connecticutchildrens.org', 'phone': '860-545-9618'}], 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'centralContacts': [{'name': 'Natasha Frederick, MD, MPH', 'role': 'CONTACT', 'email': 'nfrederick@connecticutchildrens.org', 'phone': '860-545-9618'}], 'overallOfficials': [{'name': 'Natasha Frederick, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'nfrederick@connecticutchildrens.org'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}