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NCT Number: NCT05443737

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

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.

Recruiting

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Key information

Conditions

Cancer Fertility Preservation Neoplasms

Age range

0 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis

Treatment and study plan

Multi-component oncofertility care intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

H. Irene Su, MD, MSCE

CONTACT

[email protected]

858-822-5986

Sally AD Romero, PhD, MPH

CONTACT

[email protected]

858-822-1371

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Official study title

Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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