Duke Cancer Institute
Durham, North Carolina, 27710, United States
Location status: Recruiting
Location contact
Caroline S Dorfman, PhD
PRINCIPAL_INVESTIGATOR
Michael W Willis, BA
CONTACT
Smrithi Divakaran, MBBS, MSPH
CONTACT
NCT Number: NCT07471685
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.
Interested in participating?
Request Info18 year–39 year
Female
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Caroline S Dorfman, PhD
PRINCIPAL_INVESTIGATOR
Michael W Willis, BA
CONTACT
Smrithi Divakaran, MBBS, MSPH
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
Time frame: 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.
Time frame: Post-treatment (4-6 weeks)
The intervention will be considered feasible if >80% of participants complete all four sessions.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, follow-up (8-10 weeks)
Participants will respond to a novel 8-item questionnaire assessing unmet fertility information needs. Participants will respond yes (1) or no (0) to questions asking if they have as much information as they would like about different fertility-related topics. The total score ranges from 0 to 8, with higher scores indicating a greater number of unmet fertility information needs.
Time frame: Baseline, follow-up (8-10 weeks)
Family building priorities will be assessed by the Family Building Priorities Tool, a measure that presents 10 topics that people may consider when deciding which family building options to pursue. Participants are asked to rank each item from 10 (most important) to 1 (least important).
Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Participants will be asked to indicate yes (1) or no (0) to questions asking if they have spoken with anyone about family building goals, and if they have taken any action steps toward family building goals. Participants will also be asked who they spoke with about their family building goals (if anyone), what specific steps they have taken toward family building (if they have taken any steps)), and what barriers they have faced to working toward family building goals (if they have taken no steps).
Contact information is provided by the study sponsor or research team.
Michael W Willis, BA
CONTACT
Smrithi Divakaran, MBBS, MSPH
CONTACT
Duke University
Other
Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
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.
Published trials that share one or more normalized conditions with this study.
NCT07579065
Behavior, Behavioral Symptoms
Reggio Emilia, Italy
View Trial DetailsNCT07161713
Cancer Survivors, Cancer Survivorship
Stony Brook, New York, United States
View Trial DetailsNCT06844981
Cancer Survivorship, Mental Disorders
New Brunswick, New Jersey, United States
View Trial DetailsNCT06725953
Cancer Survivorship, Chemotherapy Side Effects
Oklahoma City, Oklahoma, United States
View Trial Details