Other Cancer
Conditions
Keywords
Other Cancer
Brief summary
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
Detailed description
Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.
Interventions
BEHAVIORALMobile App + enhanced standard care
An intervention to help address sexual dysfunction among HCT survivors
Standard of care administered by the institution
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment. * Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member. * Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines
Exclusion criteria
* Recurrent disease requiring treatment * Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Based on Proportion of Subjects Enrolled | 2 years | feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups | 8 weeks | compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (raw score range 2-10). |
| Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups | 8 weeks | compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (raw score range 3-15). |
| For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups | 8 weeks | for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (raw score range 0-55) |
| Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups | 8 weeks | patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (raw score range 4-25). We will use raw score for reporting in this study given the extent of illness in this population. |
| Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups | 8 weeks | compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196) |
| Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups | 8 weeks | compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21) |
| Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups | 8 weeks | compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21) |
| For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups | 8 weeks | For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication (raw score 0-25) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile App Plus Enhanced Standard Care * Patients will received enhanced standard care in addition to access to the sexual health mobile app.
* The app will also prompt patients to engage their partners with specific exercises.
Mobile App + enhanced standard care: An intervention to help address sexual dysfunction among HCT survivors
Enhanced Standard Care: Standard of care administered by the institution | 30 |
| Enhanced Standard Care * Patients will receive Enhanced Standard Care
* Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD
* Patients will not have access to the sexual health mobile app
Enhanced Standard Care: Standard of care administered by the institution | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Mobile App Plus Enhanced Standard Care | Enhanced Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 54.5 Years | 57.7 Years | 57.2 Years |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 29 Participants | 57 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Feasibility Based on Proportion of Subjects Enrolled
feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.
Time frame: 2 years
Population: This is the total number of patients identified as eligible for the study (to reflect feasibility metric)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Study Sample | Feasibility Based on Proportion of Subjects Enrolled | 60 Participants |
Secondary
Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups
compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups | 4.5 score on a scale |
| Enhanced Standard Care | Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups | 6.4 score on a scale |
Secondary
Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups
compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups | 3.6 score on a scale |
| Enhanced Standard Care | Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups | 5.4 score on a scale |
Secondary
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups
patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (raw score range 4-25). We will use raw score for reporting in this study given the extent of illness in this population.
Time frame: 8 weeks
Population: comparison of outcomes at week-8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups | 14.6 score on a scale |
| Enhanced Standard Care | Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups | 12.3 score on a scale |
Secondary
Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups
compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (raw score range 2-10).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups | 6.70 score on a scale |
| Enhanced Standard Care | Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups | 5.7 score on a scale |
Secondary
Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups
compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (raw score range 3-15).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups | 9.7 score on a scale |
| Enhanced Standard Care | Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups | 8.3 score on a scale |
Secondary
Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups
compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups | 115.6 score on a scale |
| Enhanced Standard Care | Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups | 108.3 score on a scale |
Secondary
For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups
For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication (raw score 0-25)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups | 13.5 score on a scale |
| Enhanced Standard Care | For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups | 12.1 score on a scale |
Secondary
For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups
for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (raw score range 0-55)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Study Sample | For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups | 36.6 score on a scale |
| Enhanced Standard Care | For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups | 27.9 score on a scale |