Идёт набор NCT07471685

Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors

Без фазы С лечением Cancer Survivorship Family Planning Adolescent and Young Adult Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nurse Navigator-Delivered Family Building Decision Support, Survivorship Education.
Кому может быть актуально: Состояния в реестре: Cancer Survivorship, Family Planning, Adolescent and Young Adult Cancer. Базовые параметры: 18 лет — 39 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors

Обзор

This study aims to develop and pilot-test a nurse navigator-delivered behavioral program to support female adolescent and young adult (AYA) cancer survivors in making informed, values-driven family-building decisions after completion of cancer treatment. Female AYA survivors often face fertility impairments, uncertainty about reproductive potential, elevated obstetric risks during pregnancy, and significant emotional distress related to parenthood planning. Currently, few interventions address these post-treatment decision-making needs. The intervention consists of four videoconference sessions that combine personalized, risk-based reproductive health education with coping strategies derived from Acceptance and Commitment Therapy and Patient Activation Theory. A pilot randomized controlled trial will evaluate feasibility, acceptability, and preliminary changes in knowledge, decisional conflict, self-efficacy, and reproductive-health-related distress among 48 participants randomized to the intervention or a survivorship-education control condition. Findings will inform future testing of the intervention's efficacy in a larger clinical trial.

Вмешательства

Поведенческое Nurse Navigator-Delivered Family Building Decision Support
Four \~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include: Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management). ACT-derived coping skills (values cl
Поведенческое Survivorship Education
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

Первичные конечные точки

Feasibility as measured by number of adolescents and young adults (AYAs) enrolled [Срок оценки: up to 10 months]
Feasibility as measured by the number of participants who complete all four sessions [Срок оценки: Post-treatment (4-6 weeks)]
Feasibility as measured by frequency of program skills use [Срок оценки: Post-treatment (4-6 weeks), follow-up (8-10 weeks)]
Feasibility as measured by frequency of specific program skills use [Срок оценки: Post-treatment (4-6 weeks), follow-up (8-10 weeks)]
Acceptability as measured by the Client Satisfaction Questionnaire [Срок оценки: Post-treatment (4-6 weeks)]
Acceptability as measured by the Treatment Acceptability Questionnaire [Срок оценки: Post-treatment (4-6 weeks)]
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) [Срок оценки: Post-treatment (4-6 weeks)]

Вторичные конечные точки (5)

Decisional conflict as measured by the Decisional Conflict Scale [Срок оценки: Baseline, follow-up (8-10 weeks)]
Self-efficacy as measured by the Decision Self-Efficacy Scale [Срок оценки: Baseline, follow-up (8-10 weeks)]
Distress as measured by the Reproductive Concerns after Cancer Scale [Срок оценки: Baseline, follow-up (8-10 weeks)]
Distress as measured by the Fertility Problem Inventory [Срок оценки: Baseline, follow-up (8-10 weeks)]
Family building knowledge as measured by knowledge item pool [Срок оценки: Baseline, follow-up (8-10 weeks)]

Критерии участия

Критерии включения

Female (biological sex) AYA cancer survivor age 15-39 at original diagnosis and 18-39 at enrollment.
Completed cancer treatment with curative intent.
Prior exposure to treatments posing gonadotoxic risk (e.g., alkylating agents, total body irradiation) and/or treatments increasing obstetric risk (e.g., chest radiation, radiation to uterus, anthracycline exposure).
Has not completed family building.
Able to speak/read English.
Willing and able to complete videoconference sessions and REDCap surveys.