Adolescent and Young Adult Cancer, Cancer Survivorship, Family Planning
Conditions
Keywords
AYA, oncofertility, fertility after cancer, survivorship
Brief summary
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.
Interventions
BEHAVIORALNurse 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.
BEHAVIORALSurvivorship Education
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by number of adolescents and young adults (AYAs) enrolled | 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 | 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 | 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 | 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 | 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 | 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) | 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict as measured by the Decisional Conflict Scale | Baseline, follow-up (8-10 weeks) | Decisional conflict related to family building options will be assessed using the Decisional Conflict Scale. Participants will respond to 16 questions about decisional conflict related to family building from 0 (strongly agree) to 4 (strongly disagree). The total scores ranges from 0 to 64, with higher scores indicating greater conflict. |
| Self-efficacy as measured by the Decision Self-Efficacy Scale | Baseline, follow-up (8-10 weeks) | Self-efficacy will be assessed using the Decision Self-Efficacy Scale; items will be worded to assess self-efficacy for family building decision-making. Participants will respond to 11 items assessing decision self-efficacy from 0 (not at all confident) to 4 (very confident). The total score ranges from 0 to 44, with higher scores indicating greater self-efficacy. |
| Distress as measured by the Reproductive Concerns after Cancer Scale | Baseline, follow-up (8-10 weeks) | Distress will be assessed using the 18-item Reproductive Concerns after Cancer Scale. Participants will respond to statements with ratings from 1 (strongly disagree) to 5 (strongly agree) about concerns related to having (more) biological children. The total score ranges from 18 to 90, with higher scores indicating greater reproductive-related concerns. |
| Distress as measured by the Fertility Problem Inventory | Baseline, follow-up (8-10 weeks) | Distress will be assessed using the Fertility Problem Inventory, which asks participants to rate their agreement with 38 statements across 4 domains (social concerns, relationship concerns, rejection of childfree lifestyle, need for parenthood). Participants will rate each statement from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 38 to 228, with higher scores indicating greater fertility-related distress. |
| Family building knowledge as measured by knowledge item pool | Baseline, follow-up (8-10 weeks) | Knowledge will be assessed using an item pool developed for the study. Each participant will respond true (1) or false (0) to 10 items, with the specific items being dependent on the risk-based education provided and associated family building options discussed during the intervention sessions. Knowledge will be calculated as the percent of correct items. |
Countries
United States
Contacts
CONTACTSmrithi Divakaran, MBBS, MSPH
CONTACTMichael W Willis, BA
PRINCIPAL_INVESTIGATORCaroline S Dorfman, PhD
Duke University
Outcome results
None listed