Sexual Dysfunction
Conditions
Keywords
Sexual Dysfunction Post-Bone Marrow Transplant
Brief summary
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.
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 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.
Interventions
BEHAVIORALMulti-modality sexual dysfunction intervention
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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) with hematologic malignancy who underwent an allogeneic HCT at least 6 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 National Comprehensive Cancer Network survivorship guidelines
Exclusion criteria
* Patients with relapsed disease post-HCT. * Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Primary Endpoint | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Function: Promis Sexual Function and Satisfaction Measure | Baseline to 6 Months | Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest. |
| Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant | Baseline to 6 Months | 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. |
| Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 | Baseline to 6 Months | change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multi-modality Sexual Dysfunction Intervention \- Patients in remission \> 6 months after allogeneic bone marrow transplant
* Patient Enrollment and Baseline Data Collection
* First Intervention Visit:
* Comprehensive assessment of sexual dysfunction
* Normalization & Education
* Therapeutic interventions
* Referral to Sexual Health Clinic if applicable
* Follow-Up Intervention Visit --- Referral to Sexual Health Clinic if applicable
Multi-modality sexual dysfunction intervention | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Multi-modality Sexual Dysfunction Intervention |
|---|---|
| Age, Continuous | 52.5 years |
| Anxiety (HADS) | 4.59 units on a scale STANDARD_DEVIATION 3.32 |
| Depression (HADS) | 4.28 units on a scale STANDARD_DEVIATION 3.1 |
| Global satisfaction with sex | 16.07 units on a scale STANDARD_DEVIATION 8.16 |
| Interest in sex | 10.98 units on a scale STANDARD_DEVIATION 3.88 |
| quality of life | 107.98 units on a scale STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
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.
Time frame: 6 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm Study | Feasibility Primary Endpoint | 38 Participants |
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.
Time frame: Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Study | Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9 | 2.33 units on a scale | Standard Deviation 2.56 |
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.
Time frame: Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Study | Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant | 123.88 units on a scale | Standard Deviation 17.1 |
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.
Time frame: Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Study | Change in Sexual Function: Promis Sexual Function and Satisfaction Measure | 15.39 units on a scale | Standard Deviation 3.69 |