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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05443737
• Collaborator: Rady Children's Hospital, San Diego (Other), City of Hope Medical Center (Other)
• Enrollment: 2,400
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 67.9
• Patients Per Site: 600
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 2400 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Stepped wedge cluster randomized controlled trialStepped 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: Jan 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2027
• Anticipated Study Completion Date: Aug 31, 2027

Arms and Interventions

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

Primary Outcome Measures

1. Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 0 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010-3000
2	Cancer Resource Center of the Desert	El Centro	California	United States	92243
3	University of California San Diego	La Jolla	California	United States	92093
4	Rady Children's Hospital San Diego	San Diego	California	United States	92123

Sponsors and Collaborators

• University of California, San Diego
• Rady Children's Hospital, San Diego
• City of Hope Medical Center

Investigators

• Principal Investigator: H. Irene Su, MD, MSCE, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Chun Irene Su, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05443737
• Other Study ID Numbers: 800780
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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, Professor, University of California, San Diego: Oncofertility; Fertility preservation; Adolescent and young adult cancer

Study Results

No Results Posted as of Jul 5, 2022