Clinical trial NCT02753296: Development and Evaluation of a Fertility Preservation Patient Decision Aid for Women With Cancer.
Official title: Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cancer
Fertility Preservation
Patient Decision Aid
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Yorkshire Cancer Research
name: Weston Park Hospital Cancer Charity
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Sheffield Hallam University
name: University of Leeds
name: The Leeds Teaching Hospitals NHS Trust
name: Breast Cancer Care (Charity)
name: Independent Cancer Patients' Voice (Charity)
name: University of Oxford
First posted: 2016-04-27
Enrollment: 98
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women of a reproductive age (16yrs+), who have been diagnosed with cancer, and are undergoing or has undergone cancer treatment(s) which may impact fertility will be eligible. The sample of women will be opportunistic and identified from those women referred to the study sites.

Brief summary: The aim of this research study is to develop a patient decision aid (PDA), and evaluate whether its integration within oncology services enable cancer services to effectively support and provide evidence based resources for women's fertility preservation decisions, following a diagnosis of any cancer type.

Detailed description: Women diagnosed with cancer have to make time-pressured decisions regarding fertility preservation with specialist fertility services whilst planning their cancer treatment with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; and women report wanting more specialist information to make these choices across service pathways. This research will develop a new evidence-based patient decision aid (PDA) to address this unmet need and evaluate its acceptability to women and services when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning.

The objectives are to:

1. Develop a PDA for use by oncology teams to support women making fertility preservation choices, whilst having a recent cancer diagnosis.
2. Assess the validity of the PDA to support women making informed decisions about fertility preservation before starting their cancer treatment.
3. Evaluate the acceptability of the PDA to a) women making fertility preservation decisions whilst planning their cancer treatment and b) oncology and fertility health professionals supporting women's oncology and fertility treatment choices.

This research employs a series of prospective, observational surveys, employing both quantitative and qualitative methods to develop and evaluate the PDA.

Data will be collected during 5 time points:

1. Face validity stage- The purpose of this stage is to assess the face validity of the PDA from women and health professionals. Qualitative and quantitative data collection will aim to explore understanding, the purpose of the PDA, and views on its utility.
2. Evaluation Stage Baseline- Quantitative data collected from eligible women following their initial treatment planning consultation. Questionnaires are completed prior to reading the PDA.
3. Evaluation Stage Time 1- Quantitative data collected from eligible women on arrival to their appointment at the Assisted Conception Unit (ACU). For those women who decide not to attend their appointment with the fertility expert the questionnaires will be either posted or handed to them at their next oncology appointment for completion, at the same time point.
4. Evaluation Stage Time 2a- Quantitative data collected from eligible women following completion of their first round of chemotherapy.
5. Evaluation Stage Time 2b- Qualitative interview data collected from eligible women following completion of their first round of chemotherapy, and from health professionals.

Eligibility criteria: Inclusion Criteria: All women aged \>16 of a reproductive age, with a diagnosis of any cancer, undergoing cancer treatment(s) which may impact fertility

Exclusion Criteria: Women who have started menopause/ not of a reproductive age

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Primary outcomes:
measure: Change in decisional conflict (Decisional Conflict Scale)
timeFrame: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
Secondary outcomes:
measure: Preparation for Decision Making Scale
timeFrame: Face validity stage (within one day after reading the PDA)
measure: Change in perception (Preparation for Decision Making Scale)
timeFrame: Time 1- the next oncology or fertility consultation (within one month after reading PDA)
measure: Change in decision making readiness (The Stage of Decision Making)
timeFrame: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
measure: The Decisional Regret Scale
timeFrame: Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
measure: Change in health outcomes (The EQ-5D)
timeFrame: Baseline (within 3 days after initial treatment planning consultation); Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
measure: Change in anxiety (The State Trait Anxiety Inventory)
timeFrame: Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
measure: Count Data
timeFrame: Through study completion (an average of 18 months)
measure: Learner Verification Questionnaire
timeFrame: Face validity stage (within one day of reading the PDA)
measure: Qualitative Interviews (telephone)
timeFrame: Face validity stage (within 1 week after reading the PDA)
measure: Qualitative Interviews (face to face)
timeFrame: Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Jessop Fertility
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital Cancer Charity
state: South Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds Centre for Reproductive Medicine
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: West Yorkshire
Study officials:
affiliation: Sheffield University
name: Georgina L Jones, D.Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones GL, Hughes J, Mahmoodi N, Greenfield D, Brauten-Smith G, Skull J, Gath J, Yeomanson D, Baskind E, Snowden JA, Jacques RM, Velikova G, Collins K, Stark D, Phillips R, Lane S, Bekker HL; (On behalf of the Cancer, Fertility and Me research team). Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol. BMJ Open. 2017 Mar 13;7(3):e013219. doi: 10.1136/bmjopen-2016-013219.