Table 3 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identifying number | |
Date of registration in primary registry | March 19, 2021 |
Secondary identifying numbers | None |
Source(s) of monetary or material support | American Cancer Society |
Primary sponsor | American Cancer Society |
Secondary sponsor(s) | None |
Contact for public queries | JG, PhD, MPH [Jessica.Gorman@oregonstate.edu] |
Contact for scientific queries | JG, PhD, MPH [Jessica.Gorman@oregonstate.edu] |
Public title | Opening the Conversation |
Scientific title | Opening the Conversation for Couples With Reproductive Health Concerns |
Countries of recruitment | USA |
Health condition(s) or problem(s) studied | Reproductive and sexual distress after cancer |
Intervention(s) | Experimental Intervention Group: Opening the Conversation intervention, 5 sessions Active Comparison Group: Side by Side intervention, 4 sessions |
Key inclusion and exclusion criteria | Ages eligible for study: ≥18 years to 44 years (cancer survivor, partner 1) and ≥18 years (partner 2) Sexes eligible for study: all Accepts healthy volunteers: no |
Inclusion criteria (partner 1): cancer diagnosis between the ages of 18 and 39; current age 18–44; cancer diagnosis between 6 months and 5 years prior to enrollment date; diagnosed with breast or gynecologic cancer; self-reported cancer stages 1–4 at time of diagnosis; committed partner who is willing to participate Inclusion criteria (partner 2): age 18 or older | |
Exclusion criteria: survivors and partners are excluded if either partner does not meet the eligibility criteria; both partners must enroll in order to participate. | |
Study type | Interventional |
Allocation: randomized intervention. Parallel assignment masking: double blind (investigator, outcomes assessor) | |
Primary purpose: supportive care | |
Phase III | |
Date of first enrolment | September 2021 |
Target sample size | 100 dyads (200 individuals) |
Recruitment status | Recruiting |
Primary outcome(s) | Reproductive distress, Sexual distress (time frame: 3 months) |
Key secondary outcomes | Communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, relationship quality, relationship intimacy, sexual satisfaction, self-efficacy to communicate about sex and intimacy, and quality of life |