Part 1: online survey (quantitative) with questions on basic socio-demographic data, medical data and family characteristics (e.g. age, ethnicity, education) and information about FP.

online survey

Part 2: At the end of the online survey, participants are invited to attend one of the consecutively performed focus groups conducted according to standardized focus group methodology and moderated by a clinical psychologist and a specialist in reproductive medicine.

focus group meeting

Sibil Tschudin, PD Dr. med

This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.

In the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP).

Fertility Preservation in Men Affected by Cancer

Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid

Phase 1: exploratory online survey inquiring male cancer patients level of information with regard to FP

Phase 2: interview (strictly exploratory) in focus groups collecting data on male cancer patients level of information with regard to FP

exploratory online survey inquiring which kind of support regarding decision-making about FP do male cancer patients consider helpful

exploratory online survey inquiring how an online Decision Aid (DA) tool about FP has to be designed in order to be helpful for male cancer patients

Phase 2: interview (strictly exploratory) in focus groups evaluating which kind of support regarding decision-making about FP male cancer patients consider helpful

Phase 2: interview (strictly exploratory) in focus groups evaluating how an online DA tool about FP has to be designed in order to be helpful for male cancer patients

Krebsforschung Schweiz, Bern, Switzerland

University Hospital, Basel, Switzerland

YA-F cancer survivors will complete a baseline survey (T1) of sociodemographic and patient reported outcomes (PRO) and then will be sent a link to access the decision aid tool (website) with instructions to review the website before their upcoming visit. A follow-up survey (T2) will be emailed 4-weeks post-baseline, prior to their clinic visit, to evaluate website access and PROs. A post-visit survey (T3) will be emailed 6- weeks post-baseline (after their survivorship care visit) to assess PROs.

The decision aid intervention will be presented via a website

Online decision aid tool

Catherine Benedict

The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. The overall purpose of this research is to improve survivorship care by establishing a multi-disciplinary approach to managing cancer and fertility issues and prompt early referral to supportive and medical care resources.

Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).

Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.

Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).

Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care.

Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer

Pilot Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer

The Decisional Conflict Scale (DCS) is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. It is reliable and responsive to change, and the most widely used measure of decision-making quality. The survey has 16 questions, with responses on a 5-point scale ranging from "strongly agree" (1) to "strongly disagree" (5).

Total scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome). The outcome will be reported as the mean difference from baseline to 4-week and 6-week follow-up time points, with standard deviation.

This investigator-designed survey assesses perceived information needs about fertility topics such as the risk of infertility; risk of early menopause; options to assess fertility status; options to preserve fertility; and options for alternative family-building. The survey has 5 questions, each answered by a Yes / No response. Yes is scored as 1, and no is scored as 0. Total scores range from 0 to 5, with higher scores indicating greater perceived knowledge. The outcome will be reported as the mean difference from baseline to 4-week and 6-week follow-up time points, with standard deviation.

The Reproductive Concerns After Cancer (RCAC) Scale is a validated survey of cancer survivors' fertility and health concerns. The survey has 18 questions, answered on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total scores range from 18 to 90, with higher scores indicating greater distress (worse outcome). The outcome will be reported as the mean difference from baseline to 4-week and 6-week followup time points, with standard deviation.

The COMRADE is a measure of patient-based outcomes of risk communication within patient-provider interactions and treatment decision-making effectiveness. It consists of two subscales: Satisfaction with Communication \& Confidence in Decision-making. Items were adapted to refer to fertility and reproductive health care options. The measure has 20 questions. Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fertility Preservation in Men Affected by Cancer	NCT03876366	Cancer	online survey focus group mee...	18 Years -	University Hospital, Basel, Switzerland
Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer	NCT04200287	Cancer	Online decision...	18 Years - 45 Years	Stanford University
Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer	NCT04200287	Cancer	Online decision...	18 Years - 45 Years	Stanford University

Spots Global Cancer Trial Database for online decision aid tool