A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02492100
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction	Behavioral: Multi-modality sexual dysfunction intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Multimodal Intervention to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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

Behavioral: Multi-modality sexual dysfunction intervention

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2017

More Information

Publications

None provided.

• Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02492100
• Other Study ID Numbers: 15-158
• First Posted: Jul 8, 2015
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital: Sexual Dysfunction Post-Bone Marrow Transplant

Study Results

Participant Flow

Arm/Group Title	Single Arm Pre and Post Sexual Health Intervention
Arm/Group Description	A total of 47 patients who screened positive for sexual dysfunction causing distress agreed to participate in this pre-/post- design single-arm study
Period Title: Overall Study
STARTED	47
COMPLETED	46
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Multi-modality Sexual Dysfunction Intervention
Arm/Group Description	- 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
Overall Participants	47
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52.5
Sex: Female, Male (Count of Participants)
Female	24 51.1%
Male	23 48.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.1%
White	44 93.6%
More than one race	1 2.1%
Unknown or Not Reported	0 0%
Global satisfaction with sex (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	16.07 (8.16)
Interest in sex (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	10.98 (3.88)
quality of life (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	107.98 (22.00)
Depression (HADS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.28 (3.10)
Anxiety (HADS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.59 (3.32)

Outcome Measures

1. Primary Outcome

Title	Feasibility Primary Endpoint
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Single Arm Study
Arm/Group Description	single arm study, pre/post design
Measure Participants	47
Count of Participants [Participants]	38 80.9%

2. Secondary Outcome

Title	Change in Sexual Function: Promis Sexual Function and Satisfaction Measure
Description	Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest.
Time Frame	Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Singe Arm Pre/Post Design
Arm/Group Description	single arm pre/post design
Measure Participants	46
Mean (Standard Deviation) [units on a scale]	15.39 (3.69)

3. Secondary Outcome

Title	Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Singe Arm Pre/Post Design
Arm/Group Description	single arm pre/post design
Measure Participants	46
Mean (Standard Deviation) [units on a scale]	123.88 (17.10)

4. Secondary Outcome

Title	Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Study
Arm/Group Description	single arm study, pre/post design
Measure Participants	46
Mean (Standard Deviation) [units on a scale]	2.33 (2.56)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	no adverse events
Arm/Group Title	Single Arm Study
Arm/Group Description	single arm study, pre/post design
All Cause Mortality
	Single Arm Study
	Affected / at Risk (%)	# Events
Total	1/47 (2.1%)
Serious Adverse Events
	Single Arm Study
	Affected / at Risk (%)	# Events
Total	0/47 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm Study
	Affected / at Risk (%)	# Events
Total	0/47 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.