Sexual DysfunctionNCT02492100
A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
A study testing Multi-modality sexual dysfunction intervention in people with Sexual Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Multi-modality sexual dysfunction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Sexual Dysfunction
- Being tested
- Multi-modality sexual dysfunction intervention
- Keywords
- Sexual Dysfunction Post-Bone Marrow Transplant
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modality sexual dysfunction interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Multi-modality sexual dysfunction intervention | Experimental | - 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 Receives: Behavioral: Multi-modality sexual dysfunction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: Baseline to 6 Months
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.
Measured: 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.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492100
- Sponsor's protocol ID
- 15-158
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2015
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT02492100
- Acronym / sponsor ID
- 15-158
- Conditions
- Sexual Dysfunction
- Keywords
- Sexual Dysfunction Post-Bone Marrow Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-modality sexual dysfunction intervention | Experimental | Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modality sexual dysfunction intervention | Behavioural | Multi-modality sexual dysfunction intervention |
Primary outcome
Feasibility Primary Endpoint
Time frame: 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.
3 secondary outcomes
Change in Sexual Function: Promis Sexual Function and Satisfaction Measure
Time frame: Baseline to 6 Months
Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant
Time frame: Baseline to 6 Months
Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modality sexual dysfunction intervention in people with Sexual Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Primary Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.