Clinical trial NCT04059237: Pilot Study of a Decision Aid Intervention for Family-building After Cancer
Official title: Pilot Study of a Decision Aid Intervention for Family-building After Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-16
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests a web-based decision aid and planning too to help young female cancer survivors manage fertility and family-building issues in post treatment survivorship.

Detailed description: The overall goal of this work is to pilot test a single-arm intervention of a decision aid and planning tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.

Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a single-arm pilot trial.

Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a pre-post study design.

Eligibility criteria: Inclusion Criteria:

* Female
* Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
* Understands verbal and written English
* Desires future children or uncertainty regarding family-building plans
* Access to the Internet and use of a computer, tablet, or smartphone

Exclusion Criteria:

* Currently undergoing cancer treatment excluding long-term adjuvant or maintenance therapies, such as tamoxifen
* Significant physical or mental disability that prevents completion of study activities

Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.

Primary outcomes:
measure: Measure Decision Conflict Scale
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Fertility Information Needs
timeFrame: Baseline, 1 month, 3 months
measure: Measure Illness Perceptions Questionnaire-Revised (IPQ-R)
timeFrame: Baseline, 1 month, 3 month
measure: Measure Reproductive Concerns After Cancer (RCAC) Scale
timeFrame: Baseline, 1 month, 3 months
measure: Measure Impact of Events Scale-Revised (IES-R)
timeFrame: Baseline, 1 month, 3 month
measure: Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale
timeFrame: Baseline, 1 month, 3 months
measure: Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Catherine Benedict
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benedict C, Ford JS, Schapira L, Simon P, Spiegel D, Diefenbach M. Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study. BMJ Open. 2019 Dec 29;9(12):e033630. doi: 10.1136/bmjopen-2019-033630.