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Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients

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: NCT05443737
Recruitment Status : Recruiting
First Posted : July 5, 2022
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
Rady Children's Hospital, San Diego
City of Hope Medical Center
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.

Condition or disease Intervention/treatment Phase
Cancer Fertility Preservation Behavioral: Multi-component oncofertility care intervention Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge cluster randomized controlled trial
Masking: Single (Care Provider)
Masking Description: Fertility specialists and their support staff will be blinded to the intervention status of the cluster from which a patient is referred to minimize differences in counseling in patients whom they expect to receive financial navigation.
Primary Purpose: Supportive Care
Official Title: Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
Experimental: Multi-component oncofertility care intervention
Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.
 Behavioral: Multi-component oncofertility care intervention
The multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated.
No Intervention: Usual Care
Eligible cancer patients presenting to oncology clinical visits will receive usual care.


Outcome Measures
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Primary Outcome Measures :
  1. Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care [ Time Frame: 12 weeks after oncology visit ]
    The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.

  2. Decisional Conflict [ Time Frame: 12 weeks after oncology visit ]
    The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict).


Secondary Outcome Measures :
  1. Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care [ Time Frame: 12 weeks after oncology visit ]
    The proportion of eligible female and male patients (aged 0 to 42 years for females; 0 to 50 years for males) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.

  2. Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care [ Time Frame: 12 weeks after oncology visit ]
    The proportion of eligible female patients (aged 0 to 42 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.

  3. Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care [ Time Frame: 12 weeks after oncology visit ]
    The proportion of eligible male patients (aged 0 to 50 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed cancer or cancer relapse
  • Primary language English or Spanish
  • Receiving oncology care at participating clinical sites
  • Ages 0 to 42 years if female
  • Ages 0 to 50 years if male

Exclusion Criteria:

  • Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
Contacts and Locations
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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): NCT05443737


Contacts
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Contact: H. Irene Su, MD, MSCE 858-822-5986 hisu@health.ucsd.edu
Contact: Sally AD Romero, PhD, MPH 858-822-1371 saromero@health.ucsd.edu

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Saro Armenian, DO, MPH    626-471-7320    sarmenian@coh.org   
Principal Investigator: Saro Armenian, DO, MPH         
Cancer Resource Center of the Desert Active, not recruiting
El Centro, California, United States, 92243
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: H. Irene Su, MD, MSCE    858-822-5986    hisu@health.ucsd.edu   
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Paula Aristizabal, MD, MAS    858-966-5811    paristizabal@rchsd.org   
Principal Investigator: Paula Aristizabal, MD, MAS         
Sponsors and Collaborators
University of California, San Diego
Rady Children's Hospital, San Diego
City of Hope Medical Center
Investigators
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Principal Investigator: H. Irene Su, MD, MSCE University of California, San Diego
More Information
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Responsible Party: Hui-Chun Irene Su, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05443737    
Other Study ID Numbers: 800780
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Access Criteria: Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Chun Irene Su, University of California, San Diego:
Oncofertility
Fertility preservation
Adolescent and young adult cancer