Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility as measured by number of adolescents and young adults (AYAs) enrolled
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
研究组 & 干预措施
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 clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance.
- Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises.
干预措施: Nurse Navigator-Delivered Family Building Decision Support (Behavioral)
Survivorship Educational Materials
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
干预措施: Survivorship Education (Behavioral)
结局指标
主要结局
Feasibility as measured by number of adolescents and young adults (AYAs) enrolled
时间窗: up to 10 months
Feasibility will be assessed by study enrollment. The intervention will be considered feasible if N=48 AYAs enroll during the 10-month study period.
Feasibility as measured by the number of participants who complete all four sessions
时间窗: Post-treatment (4-6 weeks)
The intervention will be considered feasible if \>80% of participants complete all four sessions.
Feasibility as measured by frequency of program skills use
时间窗: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate the frequency with which they used skills or ideas presented in the intervention program, on a scale from 1 (not at all) to 6 (every day), since their last study session.
Feasibility as measured by frequency of specific program skills use
时间窗: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate use of 16 specific program skills or strategies since their last study session, on a scale of 1 (not at all) to 5 (6 or more days per week).
Acceptability as measured by the Client Satisfaction Questionnaire
时间窗: Post-treatment (4-6 weeks)
The Client Satisfaction Questionnaire is an 8-item scale assessing participants' views of an intervention as acceptable and satisfactory. Items are rated on a 4-point scale (e.g., 1 "very dissatisfied" to 4 "very satisfied") and averaged. The intervention will be considered acceptable if \>80% of intervention arm participants rate it as \>3 out of 4.
Acceptability as measured by the Treatment Acceptability Questionnaire
时间窗: Post-treatment (4-6 weeks)
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. The intervention will be acceptable if \>80% of intervention arm participants rate it as \>5 out of 7 on the TAQ.
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
时间窗: Post-treatment (4-6 weeks)
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
次要结局
- Decisional conflict as measured by the Decisional Conflict Scale(Baseline, follow-up (8-10 weeks))
- Self-efficacy as measured by the Decision Self-Efficacy Scale(Baseline, follow-up (8-10 weeks))
- Distress as measured by the Reproductive Concerns after Cancer Scale(Baseline, follow-up (8-10 weeks))
- Distress as measured by the Fertility Problem Inventory(Baseline, follow-up (8-10 weeks))
- Family building knowledge as measured by knowledge item pool(Baseline, follow-up (8-10 weeks))