Trial Outcomes & Findings for Reproductive Health Survivorship Care Plan (NCT NCT02667626)

Last Updated: 2020-04-20

Results Overview

50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

182 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2020-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	SCPR Intervention Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Overall Study STARTED	86	96
Overall Study COMPLETED	86	95
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SCPR Intervention Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Reproductive Health Survivorship Care Plan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCPR Intervention n=86 Participants Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.	Control n=96 Participants Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders	Total n=182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	96 Participants n=7 Participants	182 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.3 years STANDARD_DEVIATION 5.9 • n=5 Participants	39.6 years STANDARD_DEVIATION 6.0 • n=7 Participants	40.0 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	96 Participants n=7 Participants	182 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants	90 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	80 Participants n=7 Participants	157 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants	96 participants n=7 Participants	182 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Outcome measures

Outcome measures
Measure	SCPR Intervention n=86 Participants Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control n=96 Participants Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Number of Participants With a 50% Decrease in Hot Flash Score	50 Participants	53 Participants

PRIMARY outcome

Timeframe: 24 weeks

Fertility concerns subscale score \<=3. Scores for the fertility subscale calculated by averaging responses (range 1-5) to the 3 subscale questions. The minimum score is 1, the maximum score is 5, Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	SCPR Intervention n=86 Participants Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control n=96 Participants Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3	24 Participants	14 Participants

PRIMARY outcome

Timeframe: 24 weeks

Use of World Health Organization Class I or II contraceptive methods (intrauterine devices, female sterilization, male partner sterilization, combined hormonal contraception, progestin implants or injections)

Outcome measures

Outcome measures
Measure	SCPR Intervention n=86 Participants Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control n=96 Participants Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Number of Participants Using a WHO Class I or II Contraception	43 Participants	41 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

The Vulvovaginal Atrophy Score is a 4-item scale on vaginal dryness, soreness, irritation and dyspareunia experienced in the prior 4 weeks\]. Each item has a 4-point Likert scale response (0-none, 1-mild, 2-moderate, 3-severe). The scale is summarized by averaging responses, with higher scores indicating a greater level of vaginal atrophy.

Outcome measures

Outcome measures
Measure	SCPR Intervention n=86 Participants Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence	Control n=96 Participants Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Control: Web-based resource lists and text-based study adherence reminders
Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score	37 Participants	39 Participants

SECONDARY outcome

Timeframe: 24 weeks

SCPR Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irene Su, MD MSCE

University of California, San Diego

Phone: 8588225986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place