Breast Cancer, Contraception, Fertility, Hot Flashes, Sexual Dysfunction
Conditions
Keywords
Breast cancer survivor, Cancer survivorship, Survivorship care plan, Vaginal dryness, Vulvovaginal atrophy, Vasomotor symptom, Infertility, Family planning
Brief summary
The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.
Detailed description
Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study. YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks. Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions. All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues. Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.
Interventions
OTHERReproductive 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.
OTHERControl
Web-based resource lists and text-based study adherence reminders
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Breast cancer (Stages 0-III) diagnosis * Breast cancer diagnosis age ≤ 45 years * ≤ 5 years since breast cancer diagnosis * Current age 18 to 50 years * Completed treatment with surgery, radiation and chemotherapy (if applicable) * Able to read English * Able to consent to the study * Access to an Internet connection Exclusion: • Women who are pregnant at recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 50% Decrease in Hot Flash Score | Baseline and 24 weeks | 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. |
| Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3 | 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. |
| Number of Participants Using a WHO Class I or II Contraception | 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) |
| Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Provider Preparedness Scale | 24 weeks | Change in score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression (PHQ-8) | 12 and 24 weeks | Change in score |
| Menopause Quality of Life (MENQOL) | 12 and 24 weeks | Change in score |
| Social Support (MOS Social Support) | 12 and 24 weeks | Change in score |
| Insomnia Scale | 12 and 24 weeks | Change in score |
| Female Sexual Function Inventory | 12 and 24 weeks | Change in score |
| Confidence for Managing Reproductive Health Issues Scale | 12 and 24 weeks | Change in score |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 prompts. | 86 |
| 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 | 96 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | SCPR Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 96 Participants | 182 Participants |
| Age, Continuous | 40.3 years STANDARD_DEVIATION 5.9 | 39.6 years STANDARD_DEVIATION 6 | 40.0 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 90 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 77 Participants | 80 Participants | 157 Participants |
| Region of Enrollment United States | 86 participants | 96 participants | 182 participants |
| Sex: Female, Male Female | 86 Participants | 96 Participants | 182 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 96 |
| other Total, other adverse events | 0 / 86 | 0 / 96 |
| serious Total, serious adverse events | 0 / 86 | 0 / 96 |
Outcome results
Primary
Number of Participants Using a WHO Class I or II Contraception
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)
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCPR Intervention | Number of Participants Using a WHO Class I or II Contraception | 43 Participants |
| Control | Number of Participants Using a WHO Class I or II Contraception | 41 Participants |
Primary
Number of Participants With a 50% Decrease in Hot Flash Score
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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCPR Intervention | Number of Participants With a 50% Decrease in Hot Flash Score | 50 Participants |
| Control | Number of Participants With a 50% Decrease in Hot Flash Score | 53 Participants |
Primary
Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score
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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCPR Intervention | Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score | 37 Participants |
| Control | Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score | 39 Participants |
Primary
Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3
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.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SCPR Intervention | Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3 | 24 Participants |
| Control | Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3 | 14 Participants |
Secondary
Healthcare Provider Preparedness Scale
Change in score
Time frame: 24 weeks
Population: Data were not collected
Other Pre-specified
Confidence for Managing Reproductive Health Issues Scale
Change in score
Time frame: 12 and 24 weeks
Other Pre-specified
Depression (PHQ-8)
Change in score
Time frame: 12 and 24 weeks
Other Pre-specified
Female Sexual Function Inventory
Change in score
Time frame: 12 and 24 weeks
Other Pre-specified
Insomnia Scale
Change in score
Time frame: 12 and 24 weeks
Other Pre-specified
Menopause Quality of Life (MENQOL)
Change in score
Time frame: 12 and 24 weeks
Other Pre-specified
Social Support (MOS Social Support)
Change in score
Time frame: 12 and 24 weeks