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This research study is evaluating the feasibility and impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood.
- It is expected that about 50 stem cell transplant survivors will take part in this research study.
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 introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.
The intervention includes a comprehensive assessment by a transplant clinician who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve the participant's symptoms. The study will use a series of questionnaires to measure a participant's sexual function, quality of life, and mood.
The main purpose of this study is examine whether this intervention is feasible and helpful for participants in terms of improving their symptoms and overall quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-modality sexual dysfunction intervention | Experimental | - Patients in remission > 6 months after allogeneic bone marrow transplant
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-modality sexual dysfunction intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Primary Endpoint | intervention deemed feasible if at least 75% of patients screening positive for sexual dysfunction causing distress agree to participate and at least 80% complete at least one additional follow-up visit. This is not a composite outcome. Study is deemed feasible (yes) if both criteria are met. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Function: Promis Sexual Function and Satisfaction Measure | Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest. | Baseline to 6 Months |
| Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Pre and Post Sexual Health Intervention | A total of 47 patients who screened positive for sexual dysfunction causing distress agreed to participate in this pre-/post- design single-arm study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi-modality Sexual Dysfunction Intervention | - Patients in remission > 6 months after allogeneic bone marrow transplant
Multi-modality sexual dysfunction intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility Primary Endpoint | intervention deemed feasible if at least 75% of patients screening positive for sexual dysfunction causing distress agree to participate and at least 80% complete at least one additional follow-up visit. This is not a composite outcome. Study is deemed feasible (yes) if both criteria are met. | overall 94% (47 of 50) patients who screened positive for sexual dysfunction agreed to participate in the study and 80% attended at least 2 intervention visits | Posted | Count of Participants | Participants | 6 months |
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6 months
no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study | single arm study, pre/post design | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri | Massachusetts General Hospital | 248-763-3912 | ael-jawahri@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Sep 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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quality of life at 6 months compared to baseline using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant. Score range 0-164 with higher score indicating better quality of life. |
| Baseline to 6 Months |
| Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 | change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms. | Baseline to 6 Months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Global satisfaction with sex | score ranges from 3-20 with higher scores indicating more satisfaction | Mean | Standard Deviation | units on a scale |
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| Interest in sex | raw score ranges from 2-20 with higher scores indicating more interest in sex | Mean | Standard Deviation | units on a scale |
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| quality of life | quality of life measured by FACT-BMT with score range of 0-164 with higher score indicating better quality of life | Mean | Standard Deviation | units on a scale |
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| Depression (HADS) | using the HADS-Depression, score range 0-21 with higher score indicating higher depression symptoms. | Mean | Standard Deviation | units on a scale |
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| Anxiety (HADS) | using the HADS-Anxiety score range 0-21, with higher scores indicating higher anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
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| Secondary | Change in Sexual Function: Promis Sexual Function and Satisfaction Measure | Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 Months |
|
|
|
| Secondary | Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant | quality of life at 6 months compared to baseline using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant. Score range 0-164 with higher score indicating better quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 Months |
|
|
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| Secondary | Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 | change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 Months |
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| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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