|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02492100 |
|
Date of registration:
|
02/07/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
|
|
Scientific title:
|
A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
47 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02492100 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Areej El-Jawahri, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Sexual Dysfunction
|
|
Intervention(s)
|
|
Behavioral: Multi-modality sexual dysfunction intervention
|
|
Primary Outcome(s)
|
|
Feasibility Primary Endpoint
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9
[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 Sexual Function: Promis Sexual Function and Satisfaction Measure
[Time Frame: Baseline to 6 Months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|